This is certainly an exciting time to be a congenital interventional cardiologist. No doubt the later part of the 20th century laid the foundation for the new millennium; however, since the centennial celebration, several milestone events have already occurred and the future looks as bright as ever. In late 2001, the Amplatzer Atrial Septal Occluder System┬«, became the first device ever to receive US Food and Drug Administration (FDA) approval for the secundum atrial septal defect (ASD) closure indication. It currently remains the only FDA-approved device for this indication.At the same time, this device was also FDA-approved for closure of Fontan fenestrations. Nearly simultaneously in 2001 came the FDA approval of the CardioSEAL Septal Occluder System┬« for the high-risk muscular ventricular septal defect closure indication. This highly specific approved indication has been expanded with the frequent 'off-labelÔÇÖ use of this non-self-centering septal occluder for closure of small- to moderate-sized secundum ASDs as well as a host of other, less common indications. A clinical trial of a new-generation septal occluder called the BioSTAR™ has recently been launched, with bioabsorbable, drug-eluting implant technology. Device closure of the patent foramen ovale (PFO) in the setting of cryptogenic stroke is currently being evaluated in the Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment (RESPECT) trial and the CLOSURE 1 trial. Also, PFO closure device trials are likely to expand into evaluation of PFO closure in the treatment of migraine headaches, particularly those with apreceding aura.
Another milestone came in mid-2003 with the FDA approval of the Amplatzer Duct Occluder┬« for closure of the patent ductus arteriosus (PDA).This device is the first and, so far, only to be approved for the PDA closure indication.With its availability, PDA closure is now one of the most commonly performed congenital heart interventions. Consequently, patients no longer require surgical PDA ligation other than the premature infant. Additional devices in the short pipeline include devices to close perimembranous ventricular septal defects and muscular ventricular septal defects, which will eventually make it unnecessary for patients with these relatively common congenital heart defects to undergo highly invasive open-heart surgery for correction.