Centers of Excellence in Interventional Cardiology and Radiology

Congenital Heart Disease

Patent Foramen Ovale (PFO)

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Generalities

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The foramen ovale is a small hole located in the atrial septum that is used during fetal circulation to speed up the travel of blood through the heart. When in the womb,a baby does not use it’s own lungs for oxygen-rich blood, it relies on the mother to provide oxygen rich blood from the placenta through the umbilical cord to the fetus. Therefore, blood can travel from the veins to the right side of the baby’s heart and cross to the left side of the heart through the foramen ovale and skip the trip to the baby’s lungs.

Normally the foramen ovale closes at birth when increased blood pressure on the left side of the heart forces the opening to close. If the atrial septum does not close properly, it is called a patent foramen ovale. This type of defect generally works like a flap valve, only opening during certain conditions when there is more pressure inside the chest. This increased pressure occurs when people strain while having a bowel movement, cough, or sneeze. If the pressure is great enough, blood may travel from the right atrium to the left atrium. If there is a clot or particles in the blood traveling in the right side of the heart, it can cross the PFO, enter the left atrium, and travel out of the heart and to the brain (causing a stroke) or into a coronary artery (causing a heart attack).

Although it’s common to have a patent formen ovale, most people with the condition never know they have it. A patent foramen ovale is often discovered during tests for other problems. Learning that you have a patent foramen ovale is understandably worrisome, but most people never need treatment for this disorder.

How Common is Patent Foramen Ovale?

The prevalence of PFO is about 25 percent in the general population. In patients who have stroke of unknown cause (cryptogenic stroke), the prevalence of PFO increases to about 40 percent. This is especially true in patients who have had a stroke at age less than 55 years. A PFO can be associated with atrial septal aneurysm, which is characterized by excessive mobility of the atrial septum.

Symptoms of PFO

Most patients do not have any symptoms with PFO.

1. Stroke and PFO: – about 40% of patients who have an ischemic stroke have no known cause (called cryptogenic stroke). PFO is present and associated with an increase in stroke in about 40% of cases. The most common symptoms of stroke are:

weakness or numbness of the face, arm or leg on one side of the body

loss of vision or dimming (like a curtain falling) in one or both eyes

loss of speech, difficulty talking or understanding what others are saying

sudden, severe headache with no known cause

loss of balance, unstable walking, usually combined with another symptom

2. Migraine headache and PFO: – migraine headaches are more common in patients with PFO. While it seems as though closure of PFO results in improvement of migraine symptoms, larger studies are needed to confirm this finding.

The possible link between patent foramen ovale and stroke or migraine is controversial and research studies are ongoing.

3. In some cases a patent foramen ovale can cause a significant amount of blood to bypass the lungs, resulting in low blood oxygen levels (hypoxia). This usually happens when other conditions are present, such as congenital or valvular heart disease or pulmonary hypertension.

Diagnosis of PFO

PFO can be detected by echocardiogram, wich shows the structure and function of your heart. The standard form of this test is called a transthoracic echocardiogram. In some cases the patient is asked to cough or perform the Valsalva maneuver to increase pressure in the right atrium. This can increase the flow of blood from the right to left atrium.

Your doctor may also uses saline contrast study (bubble study). With this approach, a sterile salt solution is shaken until tiny bubbles form and then is injected into a vein. The bubbles travel to the right side of your heart and appear on the echocardiogram. If there’s no hole between the left atrium and right atrium, the bubbles will simply be filtered out in the lungs. If you have a patent foramen ovale, some bubbles will appear on the left side of the heart.

Transesophageal echo, can provide a closer and more detailed view of the PFO.

Indications

Most people with a patent foramen ovale don’t need treatment. In certain circumstances, however, your doctor may recommend that you have a procedure to close the patent foramen ovale.

Reasons for closure

If a patent foramen ovale is found when an echocardiogram is done for other reasons, a procedure to close the opening usually isn’t performed. Procedures to close the opening in the heart may be used in the following circumstances:

If you are undergoing to surgery to correct a congenital heart defect and you also have a patent foramen ovale, the surgeon may close the opening when making other repairs to the heart.

In adults having other types of heart surgery, a patent foramen ovale may be closed at the time of the operation.

Closure of a patent foramen ovale may be done to treat low blood oxygen levels linked to the patent foramen ovale.

Closure of a patent foramen ovale to prevent migraines isn’t currently recommended.

Closure of a patent formaen ovale to prevent a stroke remains controversial. Closure may be recommended for individuals with recurrent strokes despite medical therapy, when no other cause has been found (patients who have had a stroke or transient ischemic attack (TIA) may be placed on some type of blood thinner medication, such as aspirin, plavix (clopidogrel), or coumadin (warfarin) to prevent recurrent stroke).

Procedures to close patent foramen ovale include:

1. Device closure. Using cardiac catheterization, doctors can insert a device that plugs the patent foramen ovale.

2. Surgical repair. A surgeon can close the patent foramen ovale by opening up the heart and stitching shut the flap-like opening. This can sometimes be done with the use of robotic techniques and a very small incision.

Procedure

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The use of the percutaneous route to close the patent foramen ovale (PFO) is becoming more common. Transcatheter occlusion is an effective alternative to surgical intervention and is becoming the treatment of choice for most cases of this kind of congenital defect.

The procedure is performed in catheterism lab, using electrocardiographic control. Usually, it is done under general anesthesia; but sometimes, may be performed using local anesteshia and sedatives. Thus, after local asepsy, a small inguinal incision is made. Through this incision, the physician will introduce a small narrow tube into the femoral vein, then through this tube a catheter will be introduced which will reach the heart, under fluoroscopic control (X ray control). The interventionist will perform an angiogram, so the PFO will be visualized. A balloon may be placed across the opening to determine the size and location of the hole in your heart. Measurements are taken of the pressure inside your heart chambers. The physician will then introduce over the catheter a small device (at this time the device is folded) which will be placed at the level of the PFO. Once in the desired position (the correct position is controlled both by radiological images and transesophageal echocardiography), the device, will be opened and will obstruct the defect.

The device will be covered with normal tissue produced by the human body for the next 3-6 months.

Is it painful?

No, usually, the intervention is performed under general anesthesia.

How long does it take?

The duration of the procedure is about 1-2 hours and takes place in the cardiac catheterization laboratory.

Risks

The complications are rare; the complications are reduced by the proper preparation and the continuous surveillance of the patient. Potential complications:

• allergic reactions to administered substances, including renal disfunction

• reactions to anesthetic compounds

• arteriovenous fistulas at the vascular puncture site

• minor bleeding at the vascular puncture site

• fever

• headache, migraine

• infection

• gaseous embolism

• cardiac arrythmias

• extremely rare – cardiac perforation and cardiac tamponade (perforation of the cardiac wall and bleeding in the pericardial sac, which compresses the heart)

• embolization or device migration – in the case of device embolization, the device can usually be retrieved by transcatheter techniques, and a second device can be successfully placed in the patent foramen ovale (PFO)

• stroke

• myocardial infarction

Before procedure

The preoperative assessment will establish if the closure of the defect can be done percutaneously or there is an indication of surgical closure of the defect. Physical examination and echocardiography are key elements which help making a decision.

Prior to the intervention, the interventional cardiologist must be prevented about any history of allergic reactions. Blood tests are taken including hemoglobin level, coagulation, renal function, and other specific tests.

The patient is admitted the day before the intervention, and he/she should not eat before the procedure.

After procedure

You will be connected to monitors that will constantly display your electrocardiogram (ECG or EKG) tracing, blood pressure, other pressure readings, breathing rate, and your oxygen level. You will be given pain medication for incisional pain or you may have had an epidural during surgery which will help with postoperative pain.

Since the procedure is minimally invasive, the postprocedural recovery is usually very fast. The majority of patients can leave the hospital the following day. Indications about recovery and postprocedural treatment will be clearly specified to all patients. Treatment with aspirin and plavix must be administered 3 months post intervention in order to prevent blood clot formation within the device, after these 3 months you will continue the medical therapy with aspirin for at least another 3 monts. After 6 months it is considered that the device is completely covered by the formation of epithelial tissue, and the risk of blood clot formation disappears.

Also, in the first six months the prevention of infectious endocarditis is mandatory – antibiotic treatment (unique dose of amoxicilin, ampicilin, or clindamicin in case of pennicilin allergy) before any dental procedure carrying a risk of microbial translocation into the bloodstream. Infectious endocarditis prophylaxis is also needed in other several situations, which will be explained by our physician.

Important!

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The percutaneous closure of PFO is the first choice for treatment of PFO. It’s a minimally invasive procedure, so the recovery will be rapid. Physical exertion can be performed after one month post procedure. The physician must be informed of any complications in the postintervention period.

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