Vascular Response in the Femoropopliteal Segment after Implantation of an ePTFE Balloon-Expandable Endovascular Graft: An Intravascular Ultrasound Study

Abstract

Purpose: To use intravascular ultrasound (IVUS) to document changes in vascular 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 disease of the femoropopliteal segment were studied with IVUS immediately after endograft implantation and at follow-up. Corresponding IVUS cross sections were analyzed for changes in lumen, vessel, and plaque areas seen inside the endograft, in the anastomotic segment, and in the remote arterial segment. Results: A mean 6-month (range 1.5–9) follow-up was completed in 12 patients. Matched IVUS cross sections derived from within the endograft (n = 12) and at the endograft edges (n = 23) showed no change in lumen area (LA) in 17, reduction in 11, and dilatation in 7. Median changes within the endograft (+3%) were not significant (p = 0.28) and no neointima was found. Cross sections obtained at the anastomotic segment revealed a significant increase in LA (85%, p < 0.001), which was associated with a significant increase in 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 = 0.07). Conclusions: Following endograft placement, luminal changes within the endograft, at the endograft edges, and at the remote arterial segments were minimal. Intimal hyperplasia was not observed in the endograft. The distinct LA increase at the anastomotic segments was determined by the extent of VA and PLA change.