Placement of closed-cell designed venous stents in a mixed cohort of patients with chronic venous outflow obstructions - short-term safety, patency, and clinical outcomes.

BACKGROUND

To evaluate the performance of a closed-cell designed venous stent for the treatment of chronic ilio-femoral venous outflow obstruction (VOO) in the shortterm.

PATIENTS AND

METHODS

Safety, stent patency and clinical outcome after placement of the Vici Venous Stent® in patients with chronic ilio-femoral venous obstruction were assessed retrospectively. Stent patency was evaluated by duplex ultrasound scanning, and clinical outcome was determined using the revised Venous Clinical Severity score (rVCSS).

RESULTS

75 patients (49 % female; median age 57 years; 82 limbs) with symptomatic significant VOO had stents placed in the ilio-femoral veins. Lower limb venous skin changes including ulcers (C-class in CEAP 4-6) were found in 31 patients (41 %). Nonthrombotic iliac vein lesions (NIVLs) and post-thrombotic obstruction (PTO) were found in 40 and 42 limbs, respectively. There were no safety issues. Cumulative primary, assisted-primary, and secondary stent patency in the entire cohort at 12 months were 94 %, 94 % and 96 %, respectively. Five limbs presented with stent occlusion. Two limbs had no intervention, 2/3 remained patent after reintervention. Clinical improvement (a decrease ≥ 2 rVCSS points) was observed in 81 %, 81 %, and 77 % of patients at 1 month, 6 months, and 12 months, respectively. There was a marked drop in the frequency of more marked pain and swelling (VCSS ≥ 2) from 62 % to 5 % and 93 % to 19 %, respectively. Four limbs had venous ulcers, three healed during the follow-up. Cumulative pri- mary stent patency at 12 months was 100 % and 87 % in patients with NIVL and PTO, respectively (p= 0.032). There was no statistical difference in clinical outcome between these subgroups.

CONCLUSIONS

The Vici Venous Stent® placed in the ilio-femoral vein segment in patients with symptomatic VOO revealed no safety issues, had excellent primary patency and substantial symptom improvement. Long-term studies are needed to evaluate the durability of this stenting procedure.