Device closure of atrial septal defects first took place in the 1970’s and since then, has become an attractive alternative to surgery in the majority of secundum defects and patent foramen ovales. The design of various devices available has changed considerably, but in the majority of devices the presence of a significant amount of foreign material is still a concern, for many reasons.
We describe the first series of 10 paediatric atrial septal defect occlusions with the BioSTAR biodegradable implant device. All implants were carried out by one operator. The only inclusion criteria was a stretched diameter of 16mm or less. We retrospectively matched a cohort of patients having defect closure using the Amplatzer Septal Occluder in the same institution and era and compared procedural data and acute and mid term closure rates and complications.
The Biostar acute and mid term closure rates were both 100% compared to 90% acute and 100% midterm closure in the amplatzer patients. There were no significant complications in either group. Although the procedure and fluorocscopy times tended to be longer in the Biostar group, neither of these were statistically significant.
Although the BioSTAR device is only suitable for smaller defects and requires an 11F sheath, it can achieve at least equivalent closure rates to the Amplatzer Septal Occluder with only a minimal skeleton of foreign material remaining in the septum after 6months. Longer fluoroscopy and procedure times may be a drawback, however this may improve with familiarity with the device and deployment system.