What treatments are available for a PFO?
If someone has a cryptogenic stroke and a PFO is documented by transoesophageal echo (TOE) – a form of imaging the heart where the ultrasound probe is placed in the oesophagus, there are three ways of trying to prevent another stroke.
1. You may be placed on a potent anticoagulant ("blood thinner") called warfarin. This medication has been used for over 50 years and is given to patients who have artificial heart valves to prevent blood clots from forming on the foreign substance. Warfarin is also used to prevent blood clots in patients with atrial fibrillation, a common arrhythmia that is seen especially in elderly people. Although warfarin can be used safely, if the blood level is too high, internal bleeding can occur. This is especially bothersome for our active patients who participate in athletic activities. To prevent potential bleeding, the blood level of warfarin needs to be evaluated every 1 -4 weeks. Other blood thinners, such as clopidogrel (Plavix®), have also been used.
2. The PFO can be closed surgically. This requires the heart to be stopped and opened to repair it, using the heart bypass machine. The aim of the operation is to make the circulation of blood through the heart and lungs normal, so a patch is put over the PFO between the atria. For most adults this surgery is low risk. In addition to the obvious trauma of the operation and the required recuperation, there is some concern that the bypass machine causes small bubbles to go to the brain. Many patients report subtle memory or personality changes following open heart surgery and we suspect this may be due to the bypass machine.
3. The PFO can be closed by Catheter Intervention using an "umbrella" without a major operation. Many such devices are currently available for PFO closure: e.g the Amplatzer device, The CardioSEAL and the Gore Helix Septal Occluder.
Placing these devices is a lot easier on you than having open-heart surgery. The procedure is done in the cardiac catheterization laboratory using x-ray imaging and TOE to guide the catheter. The procedure takes about one-hour to perform. This is not regarded as surgery, you would not have to be in intensive care afterwards, and there are no chest scars or stitches.
Some ASDs do not need to be treated as they are not large enough to place strain on the heart or lungs. The ASD can also be closed surgically. This requires the heart to be stopped and opened to repair it, using the heart bypass machine. The aim of the operation is to make the circulation of blood through the heart and lungs normal, so a patch is put over the hole between the atria.
The latest treatment is Device Closure: A special spring-loaded device is passed through the catheter and straddles the hole between the two heart chambers. Placing these devices is a lot easier on you than having open-heart surgery. The procedure is done in the cardiac catheterization laboratory using x-ray imaging and transoesophageal echo to guide the catheter. The procedure takes about one-hour to perform. This is not regarded as surgery, you would not have to be in intensive care afterwards, and there are no chest scars or stitches. The stay in hospital is usually overnight.
You are usually asked to come into the hospital on the morning of the procedure and are brought to the cardiac catheterization laboratory. Intravenous sedation is given, and you will have a general anaesthetic. A transoesophageal echo probe is passed through the mouth into the oesophagus to image the heart.
Local anaesthetic is used to numb the groin over the femoral vein. A tube is placed into the femoral vein. Intravenous heparin is given to thin the blood while we are working inside the heart. A special long tube called a catheter and a long wire are passed under x-ray guidance into the heart, across the hole, and into the left atrium (see figure below). The device is loaded into a special delivery catheter. The device is placed in the left atrium and the first disk is opened. The disk is then pulled snug against the left side of the hole. When we are convinced that the device is in the correct position, we unfold the second disk in the right atrium side of the hole. This encloses or sandwiches the defect between the two disks of the device. The device is then released from its delivery catheter. The final position is observed with transoesophageal echo and then the procedure is finished. The procedure takes about one-hour to perform. This is not regarded as surgery, you would not have to be in intensive care afterwards, and there are no chest scars or stitches. You will usually be discharged home the following day, but the procedure is now performed as an out-patient basis in some centres.
Although complications with the use of these ASD/PFO devices are rare, the following events have been described:-
The device could be deployed in the wrong place inside the heart. If this occurs, the device may have to be retrieved. This can usually be done through the same catheter but may require open heart surgery. If this happened, the ASD or PFO would also be closed surgically at the same time. This has not happened with any of our cases.
Blood clots could form on the metal or fabric of the device. Since these devices are made of foreign substances, the body may respond by forming blood clots on it. To help prevent these blood clots from forming, we will start you on "blood thinners". For the procedure you will be treated with intravenous heparin. In addition, we are currently using aspirin and clopidogrel, medications that inhibit platelets in the blood from initiating blood clots. You will be required to take both these medications continuously for at least 6 months after the procedure. We have not observed any blood clots on our patients who complied with the full course of medication after the device was implanted. Within a few months, the body covers these devices with fibrous scar tissue. We believe that this prevents future clots from forming. If there are any side effects from the medications or if there is a reason you cannot take aspirin, we may add warfarin to your medicines for 6 months.
Since these devices are foreign substances, they could catch bacteria that pass through the bloodstream. Bacteria may get into your bloodstream during surgery or especially during dental cleaning. To prevent this, we recommend that you avoid dental work for six months. After six months have passed, we recommend that patients with an ASD or PFO closure device take antibiotics prophylactically, that means one-hour before any dental procedures and when other invasive procedures are performed (even tattoos or piercing). Discuss this with your dentist or doctor and we are happy to be contacted if he/she has any questions.
You may have some side effects and sensations after the procedure. These may be due to the general anaesthetic, the procedure itself or the effects of the device in the heart in the first few weeks.
In addition to the possible complications associated with this device, there are some side effects that some people have described:
You may have a sore throat for 1 or 2 days due to the tube for the general anaesthetic and the transoesophageal echo probe. This does not usually require any specific treatment. You may also notice localised tenderness and bruising in the groin from where the catheter was introduced into the heart. Simple pain killers (paracetamol) can be used safely if required.
The device may irritate the heart chambers in which it is placed. This can cause palpitations or irregular heartbeats. These sensations are usually transient and most common in the first 3-4 weeks. Depending on how bothersome these palpitations are, you could have some medications to treat the arrhythmia.
Some patients notice transient, sharp pains in the chest. These may occur without warning and usually last a few seconds. Occasionally they may be felt turning over in bed or with changes in posture. These are normal in the first 2-3 weeks after the procedure as the device 'settles into place' within the heart.
Some patients report an increased incidence of headaches in the 1-2 months following placement of the device. Most of these patients have had a history of migraine in the past so it is difficult know whether this effect is caused by the device. On the other hand, a number of reports suggest that migraine headaches are diminished following closure of the PFO.
There is one report of displacement of a device in a patient who played basketball the day after the ASD was closed. Therefore, we recommend that no strenuous physical activity be performed for one month following the device implantation. If you perform a desk job, you could return to work two days after the procedure. Do not lift anything heavier than 10 kg for 2 weeks.
You will need to take aspirin 75 mg and clopidogrel (Plavix) 75 mg for 6 months. You must return within 4 weeks for a follow-up ECHO examination. We routinely do a further ECHO with "bubble contrast" injection at 6 months to ensure that the hole is closed. You will need to take antibiotics, usually Amoxicillin (unless you are allergic to penicillin), before any dental work. This will prevent any infection getting started on the device.