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 ideal 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 HELEX, and CardioSEAL devices. 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 (FDA) Center for Devices and Radiological Health approved the Amplatzer Septal Occluder (figure 1) for percutaneous secundum atrial septal defect (ASD) closure in December 2001 . The Gore HELEX Septal Occluder was approved for percutaneous closure of secundum ASDs in August 2006. Another device, the NMT Medical CardioSEAL Septal Occlusion System, was used off-label for ASD and patent foramen ovale (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devices, the NMT Medical CardioSEAL STARFlex Septal Occlusion system and the AGA Medical AMPLATZER PFO occluder, were withdrawn in October 2006. These devices were subsequently available in the United States for investigational use only. NMT Medical, Inc ceased operations in 2011.