The Food and Drug Administration (FDA) has approved a nonsurgical technique for atrial septal defects, which has been in use in Europe for several years. Until recently, the standard procedure for the treatment of atrial septal defects (ASDs) in the U.S. has been open heart surgery. The Amplatzer PFO Occluder (AGA Medical Corp, Golden Valley, Minnesota) is a flexible device that can be delivered via a nonsurgical cardiac catheterization procedure to close the patent foramen ovale.
This minimally invasive procedure can dramatically change what was a 3-hour or longer operation to a 60- 90-minute procedure, which can be performed in a catheterization laboratory with the assistance of an x-ray camera and ultrasound. Recovery time is also reduced from weeks to hours. The FDA approval was based on an international study of closing atrial septal defects in children and adults using the Amplatzer device in more than 3500 patients. The median age of patients in the study was 12.1 years.
The study was looking for safety and efficacy of the device in this procedure. The immediate success rate was over 97% which increased to 99.2% at 3 months and 100% at 3 years. Minor complications occurred in 2.8% of the patients and serious complications occurred in less that 0.3% of the cases. There were no device related deaths.
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