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Have you had a cryptogenic stroke? PFO closure has helped thousands of people just like you.

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Every year, 15 million people around the world suffer from a stroke¹. In nearly 25% of strokes, the cause cannot be detected despite standard testing – these are called cryptogenic strokes.²

Research has shown that around 50% of young adults who’ve had a cryptogenic stroke have a hole between the left and right atrium of their heart, called a patent foramen ovale (PFO)². This condition is a potential underlying cause of a cryptogenic stroke. However, you can greatly reduce the risk of another stroke by having the PFO closed with a PFO occluder.

Learn more about PFO closure Get an overview on strokes

Did you know

25%
About 25% of strokes are cryptogenic²
50%
Nearly 50% of patients with cryptogenic stroke have a PFO³
97%
Patients experienced up to a 97% risk reduction of recurring stroke after PFO closure⁴

One week after her PFO closure, Christine was back on the treadmill running 5 miles an hour.

After Christine Lee’s stroke at age 33, her neurologist ordered a transesophageal echocardiogram to look for a PFO. Nearly six months after her first stroke, she had a TIA. Her neurologist then made a referral to an interventional cardiologist, and he recommended she get the PFO closure procedure within seven days.

Hear about her experience

I’ve had so many emails from readers who say their neurologist won’t make that referral to an interventional cardiologist. They just won’t. They want to know the name of my cardiologist, because they’re so desperate.”

— Christine Lee, USA
Amplatzer Testimonial Christine Lee Watch now
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Find out how PFO closure might help you

If you’ve had a cryptogenic stroke and are unsure if you have a PFO, contact the physician who treated you for your stroke.

If you’ve had a cryptogenic stroke and have a PFO, contact an interventional cardiologist to see if PFO closure is right for you.

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Amplatzer™ PFO occluder
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Preventing Another Stroke

With the Amplatzer™ PFO Occluder, your doctor may be able to significantly reduce the risk of another stroke. Patients who have had the PFO closure procedure have experienced up to a 97% reduction in their risk of recurring stroke.⁴

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Frequently asked questions

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

Before the PFO closure procedure, other potential causes for your past stroke should be ruled out by your neurologist and cardiologist. If your stroke was identified as a cryptogenic stroke and it’s been determined that you have a PFO, your team of doctors may recommend the Amplatzer™ PFO Occluder.

Before undergoing PFO closure, your doctors will also evaluate specific factors that need to be considered for the procedure itself, including:

  • Your overall medical status
  • The suitability of your vessels and the size and shape of your heart
  • Your suitability for general or local anesthesia
  • Your suitability to have an ultrasound imaging of your heart
  • Your suitability for the necessary radiation exposure during the PFO closure procedure
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?

The PFO closure procedure will take place in a heart catheterization laboratory, where minimally invasive procedures are performed. 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 skin incision (cut), typically in the right groin area, and inserting a small tube (called a catheter) to guide the Amplatzer™ PFO Occluder through the blood vessels to close the PFO within your heart.

Once the 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 Amplatzer™ PFO Occluder, it will be released to remain permanently in the heart, and all catheters will be removed. The procedure should last between one and two hours.

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 an Amplatzer™ 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.

What risks are associated with the PFO closure procedure?

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
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References:
  1. World Health Organization
  2. Saver, J.L. Cryptogenic Stroke. NEJM 2016; 374: 2065-74.
  3. Mojadidi, M.K. et al, Cryptogenic Stroke and Patent Foramen Foramen Ovale. Journal of the American College of Cardiology, Vol 71, No. 9, 2018 1035-42.
  4. 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.
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