Vascular response in the femoropopliteal segment after implantation of an ePTFE balloon-expandable endovascular graft: An intravascular ultrasound study

Purpose: To use intravascular ultrasound (IVUS) to document changes in vasc ular dimensions after placement of a balloon-expandable endograft. Methods: Thirteen patients (9 men; mean age 62 years, range 47-75) treated with an investigational polytetrafluoroethylene endograft for obstructive d isease of the femoropopliteal segment were studied with IVUS immediately af ter endograft implantation and at follow-up. Corresponding IVUS cross secti ons were analyzed for changes in lumen, vessel, and plaque areas seen insid e the endograft, in the anastomotic segment, and in the remote arterial seg ment. Results: A mean 6-month (range 1.5-9) follow-up was completed in 12 patient s. Matched IVUS cross sections derived from within the endograft (n = 12) a nd at the endograft edges (n = 23) showed no change in lumen area (LA) in 1 7, reduction in 11, and dilatation in 7. Median changes within the endograf t (+3%) were not significant (p = 0.28) and no neointima was found. Cross s ections obtained at the anastomotic segment revealed a significant increase in LA (85%, p < 0.001), which was associated with a significant increase i n both vessel area (VA) (42%, p < 0.001) and plaque area (PLA) (15%, p = 0. 003) area. In the remote arterial segment, the change in LA was minimal (6% , p = 0.07), as were changes in the VA (9%, p = 0.04) and PLA (10%, p = 0.0 7). Conclusions: Following endograft placement, luminal changes within the endo graft, at the endograft edges, and at the remote arterial segments were min imal. Intimal hyperplasia was not observed in the endograft. The distinct L A increase at the anastomotic segments was determined by the extent of VA a nd PLA change.