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A biodegradable device (BioSTAR™) for atrial septal defect closure in children

Background: Percutaneous closure of atrial defects (ASD) has evolved as the treatment of choice for the majority of defects and patent oval foramens. The BioSTAR™ biodegradable implant avoids many issues associated with devices containing substantial amounts of metal. Methods: Reviewed was a consecutive series of 10 ASD occlusions in a pediatric population with the BioSTAR biodegradable device. All implantations were performed by one operator. The inclusion criterion was a balloon stretched ASD diameter of ≤16 mm. Procedural data and acute and early‐term closure rates were retrospectively matched to a cohort of children having defect closure using the Amplatzer Septal Occluder™ (ASO™). Results: Acute and 6 month follow up closure rates for the BioSTAR were 90% and 100% vs. 100% and 100% closure with the ASO implants. There was a statistically significant difference in the median procedure time (52 min: BioSTAR; 39.5 min: ASO device, P < 0.05), with fluoroscopy times slightly longer for the BioSTAR group (6.7 min vs. 6.1 min, P = ns). There were no significant complications in either group. Conclusions: The BioSTAR implant can achieve comparable closure rates to the ASO in small‐ to moderate‐atrial septal defects with only a minimal skeleton of foreign material remaining after 6 months. Longer fluoroscopy and procedure times were a drawback; however, these should improve with familiarity with the implant and deployment system. © 2010 Wiley‐Liss, Inc.