How is a PFO closed using a catheter-based procedure?
Catheter-based procedures are commonly used to diagnose and treat heart-related problems. For example, catheter-based procedures are used to diagnose and treat clogged arteries and heart attacks. A catheter can also be used to guide the placement of a patent foramen ovale closure device - which becomes a permanent implant - that will close the hole (prevent the flaps from opening) in the heart wall.
To further briefly explain what happens in a PFO catheter-based procedure, a cardiac catheterization involves slowly moving a catheter (a long, thin, flexible, hollow tube) into the heart. The catheter is initially inserted into a large vein through a small incision made usually in the inner thigh (groin area) and then is advanced into the heart. One or more tests will be done to measure the PFO and to be sure there are no other defects. An imaging test called angiography, (an injection of a certain type of dye followed by an x-ray motion picture) may be used to better visualize the heart. An ultrasound imaging technique, to see the defect better and also to determine the size of the closure device needed, may be used. One technique, intracardiac echo (ICE), involves passing an imaging device up to the heart through the vein in the patient’s other leg. Another technique uses an ultrasound probe passed down the esophagus (transesophageal echo, or TEE) to allow your doctor to see the heart structures and blood flow as the device is being placed. In addition, a special balloon on a catheter is moved to the area of the hole and inflated across the hole in order to measure the size of the hole when it is gently stretched.
A PFO closure device is moved through the catheter to the heart and specifically to the location of the heart wall defect. Once in the correct location, the PFO closure device is allowed to expand its shape to straddle each side of the hole. The device will remain in the heart permanently to stop the abnormal flow of blood between the two atria chambers of the heart. The catheter is then removed and the procedure is complete.
How long does the procedure take?
The cardiac catheterization procedure for a PFO closure typically takes 2 to 4 hours to complete. A local anesthetic is used to numb the groin area where the catheter was inserted. Use of general anesthesia or sedation by IV is situation dependent -- depending on doctor preference and particular patient needs.
What types of PFO closure devices are there?
Two major types of PFO closure devices are currently being used at the Cleveland Clinic - the CardioSEAL® Occluder and the StarFlex® Occluder.
The CardioSEAL® Occluder is available for use under humanitarian device regulations. For more information on use of the CardioSEAL® Occluder under humanitarian device regulations, see the document, "Humanitarian Device Exemption (HDE)."
The CardioSEAL® Occluder consists of a two wire frameworks to which two small pieces of polyester fabric are attached. The metal in the framework and the fabric are the same that is used in implants in other open-heart and other surgeries. The implant looks like two opened square umbrellas, with the two opened sides directly against each other. Special spring coils in the framework help hold the device in place, with one "umbrella" positioned on each side of the defect. Pressure from the blood in the heart also helps to keep the device in place. Your doctor will choose an occluder device that is slightly larger than the size of the defect. Over time, the patient’s own tissue grows into and around the fabric and metal framework.
The StarFlex® Occluder is a newer version of the CardioSEAL® Occluder and is an investigational device in the United States. It is approved for use in countries outside the United States, but is only currently available to US patients who are enrolled in a clinical trial. To learn more about participating in the StarFlex® Device clinical trial, see the document, "The StarFlex® Septal Occluder of Patent Foramen Ovale (PFO): The CLOSURE I Trial."
How does the body react to a permanent implant?
The materials used in the closure device products have a proven long-term safety history and have been widely used in heart surgery procedures. It’s not likely that the body will have a negative reaction to these devices. Within a few days, the body’s own tissue will begin to grow over the device. By 3 to 6 months, the device is completely covered by heart tissue and at that point becomes a part of the wall of the patient’s heart.
The patient will not be able to feel the device. The implant will not be affected by airport or other security sensors, or by any household appliances, or medical imaging methods. However, the clarity of medical images may be slightly reduced because of the wire frame on the occluder devices. For this reason, be sure to inform the imaging technician that you or your child has such a device in your heart. You will receive an identification card that should be carried with you/or by your child to show to medical personnel if necessary.
Can a catheter-based PFO closure procedure be used in all cases?
No. At the present time, the FDA has approved the use of the CardioSEAL® Occluder for a very specific indication. The StarFlex® Occluder is available in the United States only to patients enrolled in the CLOSURE I trial, a trial being conducted at the Cleveland Clinic.
The desire to close PFOs through a nonsurgical, catheter-based procedure (such as with the CardioSEAL® Occluder) is gaining doctors’ interest. These methods may avoid the long-term need for powerful blood-thinning medications (the most often used current method of treatment) and still reduce the risk of recurrent stroke or TIA.
How does the catheter-based PFO closure procedure compare with the use of medication?
The catheter-based procedure has not been compared with medical therapy (the blood-thinning drugs aspirin, warfarin) for PFO closure in the "gold standard" format for comparison, a clinical trial. One of the goals of a trial at the Cleveland Clinic, the CLOSURE I trial, will be to determine how these two approaches to PFO closure compare in this scientific format. To learn more about this clinical trial, see the document, "Participating in the CLOSURE I Trial for the StarFlex® Septal Occluder System."
Doctors who are using or studying the CardioSEAL® or the StarFlex® Occluders believe the primary advantage of these catheter-based approaches is that they permanently seal the defect, making the long-term use of blood-thinning medications unnecessary in some patients. They also believe this approach may reduce the risk of a recurrent stroke or transient ischemic attack as much as medications have been shown to do. Although this has not been proven yet in a scientific clinical trial, such a trial is currently underway.
Your doctor will discuss these two treatment alternatives with you in order to make the best decision for you or your child.
What follow-up tests and home care instructions are typically given following a catheter-based procedure for PFO closure?
Within 24 hours after the procedure, a chest x-ray, electrocardiogram, and echocardiogram are conducted to make sure that the device is positioned correctly. Bed rest in the hospital for 6 hours after device placement is required. The patient may go home the evening of the procedure or possibly the following morning. The patient may experience minor pain at the catheter incision site and a slight sore throat for a few days if an ultrasound probe was used to check device placement. The patient will be instructed not to lift anything greater than 10 pounds for 1 week after the procedure. Your doctor will discuss when you or your child can return to regular activity (usually within a week).
Your doctor will prescribe medications that will need to be taken at home. Aspirin or other blood-thinning drug will need to be taken daily for 6 months or longer to prevent blood clots from forming. Antibiotics will also need to be taken 1 hour before certain medical procedures (for example, dental cleaning/dental surgical procedures as well as certain surgeries) for up to 1 year post device placement. Your doctor will provide information on which procedures will require antibiotic pre-treatment.
As with all medications, take them only as directed by your doctor, never stop taking the medication without talking with your doctor first, and call your doctor if you experience unpleasant reactions or have any concerns about the medication.
Finally, a few follow-up return trips to the hospital will be necessary over the next year to monitor the patient’s heart and device placement. Each visit -- at 1 month, 6 months, and 1 year -- will include a chest x-ray, electrocardiogram, and echocardiogram.
If you have any questions regarding this procedure, contact:
Kim Brown, RN, BSN
216/444-5380
800/223-2273 ext. 45380
brownk@ccf.org
© Copyright 1995-2008 The Cleveland Clinic Foundation. All rights reserved
Can't find the health information you’re looking for? Ask a Health Educator, Live!
Click here to go to the Children's Hospital Web site.
Know someone who could use this information?....send them this link.
This information is provided by the Cleveland Clinic and is not intended to replace the medical advice of your doctor or health care provider. Please consult your health care provider for advice about a specific medical condition. This document was last reviewed on: 4/26/2004
