Bioabsorbable atrial septal occluder for percutaneous closure of atrial septal defect in children.

The BioSTAR bioabsorbable septal repair implant is a new transcatheter secundum atrial septal defect occlusion device that is absorbed and replaced by healthy native tissue. This retrospective analysis was designed to determine the most significant factors for its successful use in children. From October 2009 through December 2010, 33 children underwent catheterization to close secundum atrial septal defects by means of the BioSTAR. The mean age of the patients was 6.8 ± 3.4 years (range, 2.5-13 yr), and the mean body weight was 22.6 ± 11 kg (range, 11-55 kg). The device was successfully implanted in 91% of patients (30/33). In 2 patients, the attempt had to be abandoned because of deficient aortic rim. A 3rd patient had to be converted to surgery because the device embolized to the pulmonary artery. In 1 patient, 2 BioSTAR devices were used to occlude 2 separate holes. The mean maximum stretched diameter of the single-hole defects was 13.5 ± 2.5 mm (range, 8.5-18 mm). Twenty-five patients (76%) had a single-hole defect. The mean follow-up time was 7.7 ± 4.1 months (range, 0.8-15.6 mo). The occlusion rates were 77% after 24 hours and 97% at the end of follow-up. The BioSTAR septal occluder is best suited for small-to-moderate defects. Percutaneous closure of secundum atrial septal defects with the BioSTAR is safe and effective, yielding a high success rate at midterm outcome.