Feasibility and safety of a new generation of gore septal occluder device in children.
OBJECTIVE
Transcatheter closure of an ostium secundum atrial septal defect (ASD) is now considered the standard care for most of children with the appropriate anatomy, and is a relatively well-tolerated procedure to reduce the clinical sequelae of ASD, with a low complication rate.


METHODS
The present case reports describe our clinical experience of the percutaneous closure of a secundum ASD in 10 children between December 2011 and November 2012, by means of a new generation of device, the GORE Septal Occluder device.


RESULTS
The implantation was successful in all except two cases, the device being properly placed and deployed without malposition or embolization in the catheterization laboratory. No complications were related to the procedure. The successful implant was confirmed and no major adverse events were documented in the following 3-12 months.


CONCLUSIONS
The new GORE Septal Occluder device appears to be a feasible, well-tolerated and successful tool for the closure of an ASD of 15 mm or less in childhood.
Department of Pediatric Cardiology, Ospedale Pediatrico Giovanni XXIII, Bari, Italy.
Maristella
M
Lombardi
Maria R
MR
Tagliente
Teodoro
T
Pirolo
Elena
E
Massari
Leonardo
L
Milella
Ugo
U
Vairo
D000293:Adolescent; D000367:Age Factors; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation*; D002648:Child; D002675:Child, Preschool; D018618:Echocardiography, Doppler, Color; D017548:Echocardiography, Transesophageal; D005240:Feasibility Studies; D005260:Female; D006344:Heart Septal Defects, Atrial / Q000000981:diagnostic imaging / Q000628:therapy*; D006801:Humans; D008297:Male; D011474:Prosthesis Design; D055989:Septal Occluder Device; D016896:Treatment Outcome