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Interventional Atrial Septal Defect Closure Using a Totally Bioresorbable Occluder Matrix

Development and Preclinical Evaluation of the BioSTAR Device

Christian Jux, MD^_*,_*, Harald Bertram, MD, Peter Wohlsein, DVM, Michael Bruegmann, DVM and Thomas Paul, MD, FACC^_*

^_* Departments of Pediatric Cardiology and Pediatric Intensive Care Medicine, Georg-August University, Goettingen, Germany
Hannover Medical School, Hannover, Germany
Institute of Pathology, School of Veterinary Medicine, Hannover, Germany.

View larger version (86K): [in a new window]   Figure 1 CardioSEAL device with STARFlex self-centering composed of an MP35n wire framework and a knitted polyester fabric (A). The fabric scaffold is replaced by a tissue engineered biodegradable porcine intestinal collagen layer (ICL) in the BioSTAR septal repair implant (B). An ionically bound heparin coating is applied to the BioSTAR surface. It retains the same wire framework as the STARFlex device.

View larger version (64K): [in a new window]   Figure 2 Interventionally created atrial septal defect (A) before closure using BioSTAR or STARFlex (control) devices under intracardiac echo control. The BioSTAR matrix showed an excellent echogenicity during and immediately after device deployment (B). Ao = aorta; LA = left atrium; RA = right atrium.

View larger version (88K): [in a new window]   Figure 3 Comparison of the healing response to STARFlex (A, D, G), BioSTAR devices without heparin coating (B, E, H) and with heparin-coated surface (C, F, I) after 7 days in vivo. Significantly more deposits are found on the right (A, B, C) and left atrial surface (D, E, F) of STARFlex and uncoated BioSTAR devices compared to heparin coated BioSTAR devices. The histology (G, H, I) shows the level of the scaffold (< = polyester, ** = collagen matrix) and the deposition of plasma proteins and blood cells on the device (arrows). Early signs of neo-endothelial formation are observed on heparin-coated BioSTAR devices. Top row = right atrium; middle row = left atrium; bottom row = histology. RA = right atrial aspect, LA = left atrial aspect, Histo = representative histology. H and E staining. Original magnification x10 (F, G), x20 (H).

View larger version (69K): [in a new window]   Figure 4 Comparison of the healing response to STARFlex and BioSTAR devices after 30 days to 2 years follow-up. Photos of the gross appearance of the devices were taken immediately after sacrifice and dissection of the hearts. For comparison, the right atrial surface of STARFlex control (A, C, E, G) or BioSTAR devices (B, D, F, H, I) is always shown. The orifice of the coronary sinus is located at the bottom in each of the pictures. Scale in millimeters.

View larger version (120K): [in a new window]   Figure 5 Histology of the healing response to STARFlex devices. Ingrowth of tissue from the defect edges (left margin in A) covering the polyester was found after 30 days in vivo. Newly formed fibrous tissue in parallel orientation to the device surface (B, after 90 days in vivo) led to a dense avascular formation underneath the neo-endothelium with more loosely arranged fibers and capillaries in deeper layers (C, after 180 days in vivo). A mild but chronically persisting immune response with infiltration of some lymphocytes (B to D) and foreign body giant cells (arrows in D, after 1 year in vivo) is seen around the polyester fibers. H and E staining. Original magnification x2.5 (A), x5 (B), x10 (C), x20 (D).

View larger version (94K): [in a new window]   Figure 6 Histology of the healing response to BioSTAR devices. After 30 days in vivo, first signs of remodeling of the collagen matrix were observed: fraying and longitudinal splitting of the matrix (A and B, enlarged detail in C), beginning of phagocytic resorption (C, arrows point at multinucleated giant cells) and infiltration by host fibrous cells (D) occurred. Progressive structural disintegration and absorption of the collagen matrix proceeded over time (E to J, level of residual collagen, arrowheads). Occasionally, sections showed circumscribed lymphocytic infiltrates (H, arrowhead) in close vicinity to the matrix. After 1 year, sections showed remnants of the occluder matrix (I, enlarged detail in J). The implanted collagen matrix was completely replaced by host tissue after 2 years in vivo (K, enlarged detail in L). *Rim of ASD. H and E and elastica van Gieson staining. Original magnification x2.5 (G, K), x5 (E, I, L), x10 (A, B), x20 (F, H, J), x40 (C, D).