RECENTLY PUBLISHED

THE AMERICAN HEART ASSOCIATION/AMERICAN STROKE ASSOCIATION (AHA/ASA) RELEASED UPDATED GUIDELINES ON SECONDARY STROKE PREVENTION, WITH A RECOMMENDATION FOR PFO CLOSURE.

The guidelines state that “it is now considered reasonable to close patent foramen ovale percutaneously in selected patients: those with younger age with nonlacunar stroke or no other cause at any age.”

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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™ PFO occluder

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

Learn more

Frequently asked questions

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 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.
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 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.

What happens after the PFO closure procedure?

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).
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
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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