Midterm Follow-up of Balloon-Expandable ePTFE Endografts in the Femoropopliteal Segment

Abstract

Purpose: To evaluate the midterm clinical outcome of patients treated with a balloon-expandable polytetrafluoroethylene (ePTFE) endograft for long-segment occlusive disease of the femoropopliteal segment. Methods: Eighty-nine patients (68 men; median age 69 years, range 43–81) with disabling claudication (n=73) or critical ischemia (n=16) were treated with an ePTFE endograft (mean length 29 cm) for 7 stenosis (mean length 9 cm) and 82 occlusions (mean length 19 cm) in the femoropopliteal segment. The follow-up protocol included Doppler ankle-brachial pressure measurement and duplex scanning or angiography of the endograft at 6-month intervals. Primary and secondary patency rates were analyzed. Results: At the last examination, the endograft was patent in 52 patients (median 17 months, range 7–50) and occluded in 35 (median 7 months, range 0–40);2 patients died of nonvascular causes with a patent endograft at 6.5 and 7 months. At follow-up, the primary and secondary endograft patency rates were 71% and 83% at 6 months, 57% and 69% at 1 year, 45% and 49% at 2 years, and 30% and 44% at 3 years, respectively. Conclusions: The midterm success of this new ePTFE endograft is limited; therefore, the device needs to be refined if this minimally invasive technique is to compete with conventional bypass surgery.