We report the first experience obtained with the new Intrasept device. We attempted to treat 35 patients with a mean age of 43 +/- 21 years. The mean size of the defect was 17/15 mm. It was successfully closed in 31 patients. In the remaining four the device could not be stabilized because of excessive defect size. A small residual shunt was present immediately following implantation in three patients. No complications occurred during the procedure and at 6 months, 31 patients had an uneventful outcome. Only one patient had a small residual shunt. No thrombus, embolization, or device fracture was documented during a mean follow-up of 17 +/- 11 months. Percutaneous closure of ASD ostium secundum is feasible with the Intrasept device with a high success rate and very good medium-term outcome. Our initial experience and results were excellent with small to medium size defects, however, large defects (>20 mm) remain challenging.
2006 Wiley-Liss, Inc.