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Frequently Asked Questions

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Please discuss any questions you may have with your doctor.

About PFO Closure

How do I know which treatment option is right for me?

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 a PFO occluder device. PFO occluder devices have been proven safe and effective in many large studies.1,2,3

  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. Søndergaard L, Kasner SE, Rhodes JF, et al. Patent foramen ovale closure or antiplatelet therapy for cryptogenic stroke. N Engl J Med. 2017; 377: 1033-42
What do I need to do before the PFO closure procedure?

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).

What happens during the PFO closure procedure?

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 PFO occluder through the blood vessels to close the PFO within your heart.

Once the 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.

What happens after the PFO closure procedure?

After the procedure, your medical team will discuss an after-care plan with you. You should expect to be discharged from the hospital within 24 hours. You may be prescribed aspirin (81 to 325 mg) and clopidogrel (75 mg) to be taken daily for one month after the procedure, followed by daily aspirin (81 to 325 mg) alone for at least five additional months. Your doctor may prescribe additional medication beyond six months. You will have an echocardiogram at six months so that your doctor can make sure that your occluder is properly set.

Regular check-ups with your doctor are very important. Call or see your doctor whenever you have questions or if you have any unusual problems such as bleeding, pain, discomfort or changes in your overall health.

You will also be given a PFO occluder implant card. Please carry it with you at all times and tell other doctors that you have had the procedure before any medical, dental or MRI (magnetic resonance imaging) procedures. Failure to do so may result in health problems or damage to the occluder.

How long after surgery do I need to wait to resume normal activity?

It is recommended that patients avoid strenuous physical activity for at least two weeks after occluder placement. Your doctor will provide you with more information.

Can a PFO occluder cause problems in certain places or situations?

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.

Should I be concerned about having a metal device in my heart?

The 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.

Is PFO closure right for me?

How does my doctor know I have a PFO?

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.

How does my doctor know what caused my stroke?

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
Could the PFO be the cause of my stroke?

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.

  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.

About the Procedure

How long is the procedure?

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.

What do I need to do before the PFO closure procedure?

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).

What happens during the PFO closure procedure?

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 PFO occluder through the blood vessels to close the PFO within your heart.

Once the 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.

What happens once the implant is in my body?

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

How effective is PFO closure treatment?

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.

Things to consider

What risks are associated with the PFO closure procedure?

As with any medical procedure, complications can occur. Your doctor will review the risks with you so you can decide what is right for you. 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 PFO 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
Who should not have the procedure?

Your doctor will check to make sure that you do not have:

  • A tumor or blood clots that would block delivery or placement of the occluder
  • Blood vessels that are too small to allow for delivery of the occluder
  • A body organ (all of in part) such as the heart, blood vessels, or heart valves that would interfere with the required device size
  • Other types of heart defects
  • A heart infection or inflammation of the heart

Please discuss any questions you may have with your doctor.

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