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 (TM) 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 Septa! Occluder (TM) (ASO (TM)). 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. (C) 2010 Wiley-Liss, Inc.