The FDA Reports Serious Erosion Events Associated with the St. Jude Amplatzer Atrial Septal Occluder

st_jude_amplatzer_occulder_erosionSt. Jude’s Amplatzer Atrial Septal Occluder (ASO) has been tied to rare, but very serious, erosion events, the U.S. Food and Drug Administration (FDA) just announced.

A cardiac implant device, the Amplatzer ASO, is used to treat a type of abnormal cardiac hole in children and adult. The atrial septal defect (ASD) occurs between the heart’s upper-left and –right chambers—known as the atria. The Amplatzer ASO is a metal device implanted by catheter into a vein. The procedure is considered a minimally invasive ASD closure method and is often used as an alternative to the more invasive open-heart surgery.

The FDA is now alerting patients and health care providers that the heart tissue surrounding the Amplatzer ASO can erode. This erosion can lead to dangerous, some life-threatening, emergencies that necessitate immediate surgery. Published estimates reveal that these types of serious adverse events occur in about 1-to-3 of every 1,000 patients implanted with the Amplatzer ASO. As of March 31, 2013, a total of 234,103 Amplatzer ASOs have been implanted worldwide.

Between 2002 and 2011, the agency received more than 100 erosion reports associated with the St. Jude Amplatzer ASO. During that same period, a number of medical journals published articles describing tissue erosion reported in patients implanted with the Amplatzer ASO.

When the Amplatzer ASO rubs against the heart wall, tissue erosion can occur, can create a hole, and can lead to additional scraping or erosion through tissue in the upper chambers of the heart. This damage usually occurs in the top of the atria, close to the aorta. The scraping may also cause separate or simultaneous holes in the heart’s aortic root, which could cause blood to build in the cardiac tamponade—the sac that surrounds the heart. Should this damage occur, the heart may not work properly and the patient may need to undergo immediate open-heart surgery. During surgery, the Amplatzer ASO will be removed, any holes in the heart will be closed, any other heart defects caused by the erosion will be corrected, and the original defect will be repaired.

Tissue erosion can also lead to fistulas. This is an abnormal scar tissue that connects previously unconnected parts of the heart. Although not considered life threatening, according to the FDA, cardiac fistulas do require surgery and, if left untreated, can lead to congestive heart failure.

The FDA advises patients implanted with the Amplatzer ASO who experience chest pain, numbness, sudden weakness, dizziness, fainting, shortness of breath, or rapid heartbeat to seek immediate medical attention, including an echocardiogram (ultrasound of the heart).

All patients implanted with an Amplatzer ASO should follow-up with their cardiologist to undergo echocardiogram when the device is implanted, one day after implantation, before hospital discharge, and one week following implantation. Cardiologist follow-up is also strongly recommended for one month, six months, and one year following implantation. After that, cardiologist follow-up should take place once yearly if no symptoms have occurred, according to the FDA.

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