Frequently Asked Questions

Doctors likely found your PFO when trying to find the cause of your stroke. Often, the cause of stroke is never known. These strokes are called cryptogenic (Crypto means hidden. Gen means cause.) Doctors are aware that a PFO can lead to a stroke. To reduce the risk of another stroke, your doctors may recommend closing your PFO with the Amplatzer™ PFO Occluder. More than 130,000 patients have received the Amplatzer PFO Occluder.¹ The device has been proven safe and effective in many large studies.^2,3

1. Abbott data on file.
2. Mas J-L, Derumeaux G, Guillon B, et al. Patent foramen ovale closure or anticoagulation vs. antiplatelets after stroke. N Engl J Med. 2017; 377: 1011-21.
3. Saver JL, Carroll JD, Thaler DE, et al. Long-term outcomes of patent foramen ovale closure or medical therapy after stroke. N Engl J Med. 2017; 377: 1022-32.

Be sure to talk with your doctor about any medication you may be taking, as they may advise you to adjust your medication before the procedure. Your doctor may tell you not to eat or drink anything after midnight prior to the procedure. You should arrange for a ride to and from the hospital and ask someone to help you at home (if necessary).

This minimally invasive procedure will take place in a heart catheterization laboratory. Before beginning the procedure, you will receive a sedating medication to help you relax and a local anesthetic so that you don’t feel any significant discomfort. The catheter-based procedure involves making a tiny cut, typically in the right groin area, and inserting a small tube to guide the Amplatzer PFO Occluder through the blood vessels to close the PFO within your heart.

Once the Amplatzer PFO Occluder is placed across the PFO, the cardiologist will carefully study its position using cardiac imaging tools. When the cardiologist is satisfied with the position of the device, it will be released to remain permanently in the heart, and all catheters will be removed.

You should expect to be home within 24 hours. Your doctor will talk to you about your care before you go home. Your doctor may recommend a routine like the one described here.

For one month after your procedure:

• Aspirin (81 to 325 mg) every day
• Clopidogrel (75 mg) every day

For at least six months after your procedure:

• Aspirin (81 to 325 mg) every day
• Additional medicine prescribed by your doctor

Six months after your procedure:

• An echocardiogram

Ongoing guidance:

• Visit your doctor for regular check ups.
• Contact your doctor if you have any bleeding, pain, discomfort or changes in your overall health.
• Carry your Amplatzer™ PFO Occluder implant card with you at all times.
• For your safety and to avoid damage to your occluder:
  • Tell all medical professionals that you have had PFO closure.
  • Talk about your implant BEFORE you have any imaging procedures: medical, dental, or MRI (magnetic resonance imaging).

You should avoid strenuous physical activity for at least two weeks after your procedure. Your doctor will provide you with more information.

Your PFO occluder will not be affected by household appliances or security systems. Tell all your doctors, including your dentist, that you have a PFO occluder. If you need medical imaging, tell the technician that you have a PFO occluder. The device may reduce the clarity of your medical images.

The Amplatzer™ PFO Occluder contains a nickel-titanium alloy. This is considered safe for most people. It may not be the right choice for people who are allergic to nickel or who have allergies to metal. Talk to your doctor to determine the right treatment option for you.

A heart specialist (cardiologist) looks at results of a test called an echocardiogram (eck-oh-kar-dee-oh-gram). This test uses sound waves to create pictures of your heart. These pictures can show if there is a problem with the way the heart is formed. They can also show if there is a problem with the way blood flows through the heart.

A cardiologist may want a detailed look at blood flow in the heart. They do this through a bubble study and it is another way a doctor looks for a PFO.

Your doctors will do everything they can to find the cause of your stroke. However, the cause of ischemic stroke is not known in thirty percent of people.

Your neurologist and cardiologist will gather information about your brain, heart, and blood vessels. The following tests may be used to collect images and other health information:

• Ultrasound
• CAT Scan (CT)
• Magnetic Resonance Imaging (MRI)
• EKG/ECG
• Blood tests

About one in four people has a PFO.¹ Most do not have a stroke. However, you had an ischemic stroke and now your doctors know you have a PFO. There may be a link. Your doctors will investigate.

In some cases, a PFO plays an important role in causing stroke. A PFO can permit a blood clot to pass from the right atria to the left atria in the heart. If the clot blocks a blood vessel that supplies the brain, it causes an ischemic stroke. Read more about PFO and stroke here.

1. Kutty et al, Patent Foramen Ovale. The known and the to be known. Journal of the American College of Cardiology. 2012. Vol 59 (19) 1665-71.

PFO closure can often be done as an outpatient procedure and should last between one and two hours. It is often done without general anesthesia. You can expect to go home the same day.

Be sure to talk with your doctor about any medication you may be taking, as they may advise you to adjust your medication before the procedure. Your doctor may tell you not to eat or drink anything after midnight prior to the procedure. You should arrange for a ride to and from the hospital and ask someone to help you at home (if necessary).

This minimally invasive procedure will take place in a heart catheterization laboratory. Before beginning the procedure, you will receive a sedating medication to help you relax and a local anesthetic so that you don’t feel any significant discomfort. The catheter-based procedure involves making a tiny cut, typically in the right groin area, and inserting a small tube to guide the Amplatzer PFO Occluder through the blood vessels to close the PFO within your heart.

Once the Amplatzer PFO Occluder is placed across the PFO, the cardiologist will carefully study its position using cardiac imaging tools. When the cardiologist is satisfied with the position of the device, it will be released to remain permanently in the heart, and all catheters will be removed.

Within a few days of the procedure, your body’s own tissue will start to grow over the Amplatzer PFO Occluder. The device becomes imbedded in your heart, where it may stay permanently.

The goal of PFO closure is to reduce the risk of your having another stroke. Studies show that PFO closure significantly reduces this risk.^1,2 There have been multiple studies that have compared the experience of patients who received PFO closure along with medicine that reduces blood clots, to that of patients who only received medicine. The American Academy of Neurology analyzed the results of these studies and taken together concluded that PFO closure plus medicine reduces the risk of a second stroke by 59% compared to medicine alone.³

1. Mas J-L, Derumeaux G, Guillon B, et al. Patent foramen ovale closure or anticoagulation vs. antiplatelets after stroke. N Engl J Med. 2017; 377: 1011-21.
2. Saver JL, Carroll JD, Thaler DE, et al. Long-term outcomes of patent foramen ovale closure or medical therapy after stroke. N Engl J Med. 2017; 377: 1022-32.
3. Messé et al, Practice Advisory update summary: Patent foramen ovale and secondary stroke prevention. Neurology, 2020, 94: 876-885.

More than 130,000 people have received an Amplatzer PFO Occluder.¹ The safety of the device has been proven in several large studies. One study followed patients for a median of 5.9 years.²

1. Abbott data on file.
2. Saver JL, Carroll JD, Thaler DE, et al. Long-term outcomes of patent foramen ovale closure or medical therapy after stroke. N Engl J Med. 2017; 377: 1022-32.
   

The Amplatzer PFO Occluder is a device that is implanted in the heart to close a PFO. The device has two connected discs that are made from Nitinol wire mesh.

No, the Amplatzer™ PFO Occluder stays in the heart permanently. Once the device has been implanted, your own heart tissue grows over the device.

Talk to you doctor about allergy testing. Results may show how you would respond to the nitinol wire in the device. If you have a metal allergy, your doctor may do a patch test before deciding if the implant is right for you.

If you have insurance through your employer or pay for private insurance, PFO closure is most likely covered. Check your insurance policy for coverage criteria and exclusions. This information can be found on most private insurance company websites.

Abbott recommends prior authorization to ensure a patient meets the criteria for coverage before scheduling the procedures. Your physician will prepare and request a prior-authorization on your behalf. Please note that standard Medicare does not require or accept prior authorization requests for procedures

Prior-authorization is a process many insurance companies require before a procedure such as PFO closure. This process helps you and your healthcare provider understand if the procedure will be covered and under what conditions. The process varies, but typically requires a letter from your doctor. In this letter, your doctor will describe the medical necessity of the procedure for you.

As with any medical procedure, there is a possibility of complications. The most serious risks include:

• Blood clot in the heart, leg or lung, requiring long-term anticoagulation therapy
• Blood or fluid build-up between the heart muscle and the sac that covers the heart, requiring a drainage procedure
• Irregular and/or rapid heart rate (particularly atrial fibrillation)
• Perforation of the heart muscle or vessels
• Stroke (major or minor)
  
• Death

Additional potential risks associated with the procedure or the occluder include:

• Allergic reaction to anesthesia
• Allergic reaction to the contrast dye used to visualize the heart during the procedure
• Allergic reaction to a drug used during the procedure
• Allergic metal reaction: Nitinol (nickel, titanium), platinum/iridium, stainless steel (chromium, iron, manganese, molybdenum, nickel)
• Irregular heart rhythm
• Bleeding
• Blood clot on the occluder
• Blood vessel blockage due to blood clots or air
• Chest pain
• Fever
• Fluid buildup around lungs
• Headache or migraine
• Heart attack
• Heart valve damage that interferes with valve closure
• High or low blood pressure
• Incomplete closure of PFO
• Infection
• Injury to the heart or vessels
• Injury to the nerves in the arm or lower neck
• Movement of the occluder from its position within the PFO or to other parts of the body
• Sudden interruption of blood flow to an organ or body part
• Surgery or intervention to remove the occluder
• Trouble or inability to breathe

The Amplatzer PFO Occluder should not be implanted in patients who:

• Have a tumor or blood clots at the implantation site of the device or in the vessels through which the device is advanced to reach the heart
• Have blood vessels too small to allow the delivery system to pass through
• Have an anatomy in which the device would interfere with heart or vascular function
• Have other types of heart defect
• Have infection of the heart