The AMPLATZER™ Septal Occluder
What is an atrial septal defect? Is the AMPLATZER Septal Occluder a treatment option for me?
An atrial septal defect (ASD) is an abnormal opening (hole) in the wall between the two upper chambers (atria) of the heart. This opening allows abnormal flow of blood between the atria chambers and usually results in too much blood flow to the lungs (Figure 1).
There are a number of options available to treat an ASD and no single option is best suited for every patient. A discussion with your physician will help determine the best treatment option for you. Medication may be used in treating symptoms associated with the ASD. Other treatment options to correct the defect are open-heart surgery and catheter-based procedures, which includes treatment with an AMPLATZER Septal Occluder (Figure 2).
The AMPLATZER Septal Occluder is a device specifically designed to close an ASD. The device is implanted during a catheter-based procedure and remains permanently implanted. The device is made from a braided metal (Nitinol) that has shape memory characteristics; this means the device will go back to its original shape even after it is stretched to pass through a catheter.
I have or am thinking of getting an AMPLATZER Septal Occluder. What risks should I be aware of?
Your physician is your best source of information and can help you understand the potential risks associated with catheter-based procedures and the AMPLATZER Septal Occluder device. For a description of the potential risks, please read the patient brochure (A Patient’s Guide to the Non-Surgical Closure of an Atrial Septal Defect).
I have heard about erosion associated with the AMPLATZER Septal Occluder. What do I need to know?
Erosion is a rare1 but very serious condition caused by the device rubbing against the wall of the heart, creating a hole. Erosion can cause the device to scrape (abrade), or wear, through the heart tissue of the upper chambers (atria) of the heart, primarily in the roof of the atria near the aorta. This may cause blood to build up in the sac surrounding the heart, a condition known as cardiac tamponade. If too much blood builds up in this sac, the heart will not be able to work properly.
As of May 2012, it is estimated that world-wide, erosion may occur between one in every 300 implants and one in every 1,000 implants.1 This means the incidence is estimated to be somewhere between 0.1% and 0.3%.1 The majority, almost 90%, of erosions occur within 1 year of being implanted, but some erosions have happened several years after implant.1
Erosion is rare, but can be life threatening.
Symptoms of erosion may include shortness of breath and/or chest pain, fainting and irregular heart-beat. If you have ANY of these symptoms, immediately call your doctor or go to the emergency room for an echocardiogram (ultrasound of the heart). An echocardiogram will allow the doctor to determine whether you have this complication and recommend treatment options to correct it.
How often should I see my doctor after I have been treated with an AMPLATZER Septal Occluder?
Talk with your physician about recommended care following your device implant. Generally, echocardiograms are recommended at the time of implant, one day after implant, prior to discharge from the hospital, and one week, six months and 12 months after implant. Thereafter, annual follow-up visits with your cardiologist are recommended.
- Crawford GB, Brindis RG, Krucoff MW, et al. Percutaneous atrial Septal Occluder devices and cardiac erosion: A review of the literature. Cathet Cardiovasc Intervent. 2012(80)2:157-67.
Last Reviewed: January 18, 2013 MM01068 (01) Global 12/12