Resorbable Heart Device Effective in Kids

By Crystal Phend, Senior Staff Writer, MedPage Today
Published: July 20, 2010
Reviewed by Dori F. Zaleznik, MD; Associate Clinical Professor of Medicine, Harvard Medical School, Boston and
Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner 

A novel partially biodegradable device appears to close small to moderate congenital atrial septal defects (ASD) in children as well as the standard permanent device does, according to a small cohort study.

The biodegradable BioSTAR device implanted in 10 eligible patients successfully closed 90% of small to moderate size holes within 24 hours, compared with 100% of repairs among 10 matched controls with the most commonly-used nonbiodegradable implant, reported Lee Benson, MD, of the Hospital for Sick Children in Toronto, and colleagues.

At six months, closure rates were 100% for both devices, the researchers reported in the July issue of Catheterization and Cardiovascular Interventions.
Only one child had a residual hole with the new device, a shunt of less than 2 mm (0.078 in), in an area of prolapsed anterior arm, which the authors termed of "no hemodynamic significance."

This suggested that there had been sufficient overgrowth of the novel device, which leaves behind only the metal supporting arms after the collagen discs dissolve within six months, they said.
While Benson's group suggested the device be considered for repairing small-to-moderate ASDs, they noted that this size of hole is relatively uncommon and the learning curve is steep.
However, a biodegradable closure that leaves behind minimal metal may solve the problem of transseptal access in treating the heart rhythm disorders that show up often decades later in children with ASDs, they suggested.
Traditional devices with substantial amounts of metal have been linked to late complications including erosion, apparently from chronic friction with the cardiac chamber walls, Benson's group said.
The study included a consecutive series of 10 children treated with the BioSTAR biodegradable device by a single operator (in Canada, where the device has regulatory approval) for atrial septal defect occlusions of 16 mm (0.62 in) in diameter or smaller.
The 10 controls were matched for defect size, imaging modality, and body weight from a cohort of 54 children treated for ASD closure using the nonbiodegradable Amplatzer Septal Occluder.
Device implantation was ultimately successful in all cases, although one biodegradable device had to be retrieved and replaced with a larger size version during the procedure due to instability.
No vascular complications were seen in either group, which has been a concern in adult patent foramen ovale closure. Nor were there any thrombotic or bleeding complications reported.
Hospital stay and recovery times were similar between groups as well.
However, the biodegradable device resulted in substantially longer procedural times at a median of 52 versus 39.5 minutes (P<0.05). It didn't prolong fluoroscopy time, though, compared with the standard device (median 6.7 versus 6.1 min, P=NS).

 

Primary source: Catheterization and Cardiovascular Interventions
Source reference:
Morgan G, et al "A biodegradable device (BioSTARTM) for atrial septal defect closure in children" Catheter Cardiovasc Interv 2010; DOI: 10.1002/ccd.22517.