Healing response associated with balloon-dilated ePTFE

Deployment of endovascular grafts composed of a metallic stent surrounded by expanded polytetrafluoroethylene (ePTFE) stretches the polymer beyond its original dimensions, altering the structural characteristics of the ePTFE. We hypothesized this structural modification would alter the healing response associated with the implant. In this study, 4 mm i.d. of ePTFE (30 microns internodal distance) vascular grafts were balloon dilated using angioplasty balloons having final diameters of 6 (1.5X), 8 (2X), 10 (2.5X), 12 (3X), and 18 (4.5X) mm. Following balloon dilatation of the ePTFE, a circular punch (6 mm in diameter) was used to prepare polymer samples for implantation. The ePTFE circular patches were implanted within subcutaneous tissue and epididymal fat pads of male Sprague-Dawley rats. After 5 weeks, the implants were removed and analyzed for fibrous capsule formation, inflammation, and neovascularization associated with the material. Histological analysis revealed the formation of fibrous capsules only with control subcutaneous implants. The inflammatory response associated with subcutaneously implanted ePTFE was decreased significantly following balloon dilatation to at least 2.5 times the original diameter of the graft. In contrast, ePTFE implanted within adipose tissue demonstrated a significantly greater inflammatory response following balloon dilatation when compared to control implants. Only ePTFE balloons dilated to 6 mm and implanted within adipose tissue demonstrated neovascularization to any extent. These data suggest the structural modifications incurred by ePTFE following balloon dilatation dramatically affect the inflammatory response associated with an implant. Therefore, polymeric materials used for endovascular graft technology require designs that consider changes in polymer healing inherent to device design.