In Vitro Evaluation of the Gore Viabahn Balloon-Expandable Stent-Graft for Fenestrated Endovascular Aortic Repair

Abstract

Purpose: To evaluate the safety and integrity of a new stent-graft as a potential bridging device in fenestrated stent-grafts using an in vitro fenestrated model. Materials and Methods: Polyester test sheets with ten 6-mm- or 8-mm-diameter fenestrations were used to simulate a fenestrated main body endoprosthesis. In total, 50 Viabahn balloon-expandable (VBX) stent-grafts of varying lengths (29 and 39 mm) and diameters (6, 7, and 8 mm) were implanted in the fitting fenestrations. After release, the 6- and 7-mm-diameter stent-grafts were flared with a 10×20-mm angioplasty balloon; a 12×20-mm balloon was used in the 8-mm-diameter devices. Safety of the devices was defined as absence of fractures detected on radiography or computed tomography (CT), as well as material failure detected by microscopy and water permeability testing. The forces (in Newtons, N) needed for perpendicular dislocation (pullout force) and axial dislocation (shear stress force) were also evaluated. Results: Forty VBX stent-grafts were subjected to digital radiographic imaging and multiplanar CT. None showed any stent fracture. Subsequent microscopy indicated no damage to the fabric or separation of the graft after flaring. Ten VBX stent-grafts underwent water permeability testing after flaring; no water passed through the graft wall during a 10-minute period under an intraluminal pressure at 120 mm Hg. Testing of 25 VBX stent-grafts revealed initial pullout forces between 11.3 and 31 N. Shear stress tests showed that the average force needed to dislocate the stent-grafts by 50% of their diameter ranged between 5.75 and 6.91 N (mean 6.1±0.5 N) for the 6-mm stents and between 3.31 and 5.4 N (mean 4.4±0.8) for the 8-mm stents. Conclusion: This preliminary study demonstrated the applicability of the VBX as a bridging stent-graft in a simulated fenestration model. A comparison with other stent-grafts and clinical assessment are required.