Treatment for long-segment femoro-popliteal obstructions: initial experience with a 4-F compatible self-expanding nitinol stent and review of the literature

Abstract

Aim: The aim of this paper was to evaluate the efficacy of a novel 4-F compatible self-expanding Nitinol stent for the treatment of long femoro-popliteal obstructions.

Methods: This retrospective analysis includes patients with femoro-popliteal obstructions ≥ 120 mm in length, treated with a novel Nitinol stent (Pulsar-18) between February 2010 and December 2011. Patients were categorized as either intermittent claudication (IC) or critical limb ischemia (CLI). Primary endpoint was primary patency, secondary endpoints were target lesion revascularization (TLR).

Results: A total of 31 patients (IC: N=18 and CLI: N=13) were included in the present series. Mean age was 73.3 ± 10.1 years and 71% (22/31) of the patients were male. Primary intervention was performed in 77.4% (24/31) of the patients and re-do revascularization in the remaining. Mean lesion length of femoro-popliteal obstructions was 163.5 ± 32.5 mm. Technical success was obtained in all patients. Mean follow-up duration was 316 ± 198 days. Primary patency rates were 83.3% in IC and 80.0% in CLI patients at 6 months and 64.1% and 54.9% at 12 months, respectively (P=0.84). Target lesion revascularization occurred in 5.6% of IC and 20.0% of CLI patients at 6 months and in 14.1% and 36.0% at 12 months, respectively (P=0.43).

Conclusion: Endovascular stenting of long femoro-popliteal lesions using the Pulsar-18 stent provides acceptable results with patency and restenosis rates comparable with data from literature for stenting of long femoro-popliteal obstructions.