Frequently Asked Questions

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

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).

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.

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.

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 is not suitable for patients who:

• Have a tumor or blood clots at the site where the occluder will be placed or in the vessels through which it will be used to reach the heart
• Have blood vessels too small to allow the delivery system to pass through
• Have an anatomy in which the occluder would interfere with heart or vascular function
• Have other types of heart defects
• Have a heart infection

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.

Your PFO occluder will not be affected by household appliances or security systems. There may be an issue with clarity of medical images, such as MRI, which could be slightly reduced because of the wire nitinol braid of the Amplatzer™ PFO Occluder. For this reason, you should inform the imaging technician that you have a PFO occluder.

Although Amplatzer™ products have always met the standards for nickel leaching, in 2014 those standards were improved through the use of Intaglio wire treatment on all Amplatzer™ PFO Occluders. The Intaglio wire treatment reduces the amount of nickel that may be leached by more than 95% depending on the model.

The Amplatzer™ PFO Occluder consists of a nickel-titanium alloy, which is generally considered safe. However, patients who are allergic to nickel may have an allergic reaction to this device, especially those with a history of metal allergies.

Amplatzer™ products have always met the standards for the release of small nickel ions; in 2014, those standards were improved through the use of “Intaglio” (Titanium Oxide), a protective layer that serves as a barrier between the blood and the nickel present in the device. This protective barrier has been tested to reduce the amount of nickel that may be released by more than 95%, depending on the model. Lower levels of nickel increase safety and may reduce the potential for an adverse reaction to nickel.¹ Please talk to your doctor to determine the right treatment option for you.