Experimental Preseeding of the STARFlex Atrial Septal Occluder Device with Autologous Cells

Devices used in interventional cardiology are permanent implants. However, most of the devices fulfill only a temporary function. For example, atrial septal defect (ASD) occluders serve as mechanical shields until complete in‐ and overgrowth of the occluding device by endogenous tissue from the defect edges has occurred. Thereafter, the foreign body material of the devices is no longer needed and bears potential long‐term adverse effects. The concept of “biodegradable” occluder devices that act as transient mechanical shields to close the defects and as scaffolds for overgrowth with autologous tissue is, therefore, tempting. Since rapid and complete ingrowth as well as coverage by firm tissue is a prerequisite for any such “biological” occluder devices, the feasibility and short‐term in vivo response to STARFlex devices preseeded with autologous cells was studied in an experimental sheep model. The experiments demonstrated that autologous cell preseeding of cardiovascular implants is technically feasible. Cells survived the mechanical stress of device implantation. A precoating of conventional STARFlex occluders led to an increased cellular density after cell seeding of the device, an increased resistance of the precultured cytolayer against mechanical stress, and a significantly higher poststress viability of “implanted” cells. Experimental closure of ASD using autologous‐cell preseeded STARFlex devices was uncomplicated. In the sheep model this led to rapid, complete, and firm ingrowth of the device into the adjacent atrial tissue. A thicker layer of young fibrous granulation tissue in organization was found on the preseeded devices compared with the unseeded control group after 4 weeks in vivo. Currently, an increased thrombogenicity limits in vivo application.