Atrial septal defect (ASD) is the most common congenital lesion in adults after bicuspid aortic valve, while a patent foramen ovale (PFO) can be detected in approximately 30 percent of normal adult hearts.
Percutaneous device closure is an effective, safe, and commonly employed alternative to surgical closure in patients with ostium secundum ASDs and PFOs that have appropriate indications and anatomic characteristics. The limited data comparing surgical and percutaneous closure of a secundum ASD suggest that the rates of procedural success may be comparable or possibly better with surgery, but that the rate of complications and length of hospital stay may be reduced with the percutaneous approach.
This topic will review the characteristics of the Amplatzer, Gore Helix, and CardioSEAL devices and other devices that are still investigational. Atrial septal defect closure is indicated largely to treat hemodynamic effects. PFO closure is indicated for platypnea-orthodeoxia syndrome; its efficacy for stroke prevention is not established. Indications for and efficacy of percutaneous repair of ASDs and PFOs and associated complications are presented separately. (See "Management of atrial septal defects in adults" and "Management and outcome of isolated atrial septal defects in children" and "Patent foramen ovale" and "Treatment of atrial septal abnormalities (PFO, ASD, and ASA) for prevention of stroke in adults".)
The United States Food and Drug Administration's Center for Devices and Radiological Health approved the Amplatzer Septal Occluder (figure 1) for percutaneous secundum ASD closure in December 2001 . The Gore Helix Septal Occluder was approved for percutaneous closure of secundum ASDs in August 2006. Another device, the CardioSEAL Septal Occlusion System has been used off-label for ASD and PFO closure but is FDA approved for use only for closure of certain complex ventricular septal defects.
The humanitarian device exemptions for two patent foramen occluder devices, the CardioSEAL STARFlex Septal Occlusion system and the Amplatzer PFO occluder were withdrawn in October 2006. These devices are now available in the United States for investigational use only.