PFO (Patent Foramen Ovale) Closure

This practice does not deal with patients under the age of 16. Adults with Patent Foramen Ovale (PFOs) often have minimal symptoms. In addition it may be picked up when doing a routine electrocardiogram (ECG) or echocardiogram (TTE).

Four different unbrella devices used for PFO/ASD closure (Starflex, Biostar, Amplatser and Premere (from top left clockwise). Other devices are also available.

X-rays of a PFO closure procedure. Start Top left and following clockwise. Balloon across PFO to check the size. Then 1st arms of umbrella pulled against left side of PFO. Then send umbrella arms of the same device placed on the right side of the PFO, sandwiching the flap. Final panel shows the delivery stalk detatched so the device is left in place.

The Procedure

This involves closing the hole without needing to cut the chest. There is >95% chance of successful closure.

• You are given a either a general anaesthetic or local anaesthetic.
• The operation is guided by X-rays from the outside, and sometimes by ultrasound pictures from a probe in your throat or your leg.
• A pipe is passed from a needle puncture in the leg to the heart.
• A wire is passed across the hole in the heart.
• A balloon is used to see how big the hole is.
• A stiff tube is passed over the wire and an umbrella device is placed across the hole.
• The pipes are taken out and the hole in the leg (where the pipes have been) is pressed on to stop the bleeding.

What are the complications?

Your blood is thinned during the procedure. Therefore there can be bleeding problems from the leg and also internally. Sometimes blood leaks into the bag surrounding the heart and a further procedure is needed to help release it. Very rarely emergency surgery is required. The complications are :

• Rhythm problems - this usually settles with medication.
• Bleeding (see above)
• Device detatchment- if the umbrella moves, then it has to be recaptured. If it cannot be recaptured, then surgery may be needed to remove it.
• Stroke- if a small clot form on the device or any of the pipes and moves to the brain.

The complication rate is up to 2% after the procedure. Death is very rare.

How does the body react to a permanent implant?

The materials used in the devices 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 your heart.

You 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 including MRI scans. For this reason, be sure to inform the doctor that you have 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.

What happens after the procedure?

Within 24 hours after the procedure, 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.

• You might go home the evening of the procedure or possibly the following morning.
• You 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.

What can and cant I do?

• You can drive after 1 week.
• You can go back to work after 1 week
• Do not lift anything greater than 10 pounds for 1 week after the procedure.
• Please avoid planned dental treatment for at least 3 months. Antibiotics may also need to be taken 1 hour before certain medical procedures (for example, dental cleaning/dental surgical procedures as well as certain surgeries) if you have to have these procedures within the 1st 6 months.