Effects of balloon dilatation on ePTFE structural characteristics

Abstract

The search for less invasive treatments for cardiovascular disease has lead to the development of endovascular stent grafts, metallic and alloy stents surrounded by prosthetic vascular graft material. Introduced intravascularly, the deployment of stent grafts requires balloon dilatation of the device which results in expansion of the stent along with the vascular graft material. We hypothesized that balloon dilatation of stent grafts would alter the physical structure of the prosthetic graft material. In this study, noncompliant angioplasty balloons were used to dilate expanded polytetrafluoroethylene (ePTFE), a material commonly used for endovascular stent-graft technology. The maximal outer diameter (inflated balloon within the lumen) and the recoiled outer diameter (balloon removed) of two types of ePTFE, 3-mm inside diameter (i.d.) thin wall (30-micron internodal distance) and 4-mm i.d. standard wall (30-micron internodal distance), were measured to compare material recoil. Following balloon dilatation, ePTFE samples were prepared for scanning electron microscopic examination and the following parameters were measured: wall thickness, internodal distance, nodal width, interfiber distance, and fiber width. Following primary dilatation, both types of ePTFE recoiled approximately 20% regardless of inflated balloon diameter. However, following eight repetitive balloon dilatations, recoil decreased to approximately 10%. Scanning electron microscopic analysis revealed variations in internodal distance and significant decreases in wall thickness, nodal thickness, and interfiber distance. Fiber width was significantly decreased following dilatation of 3 mm, but not 4 mm ePTFE. Our data support our initial hypothesis that balloon dilatation alters the structure of ePTFE.