Comparison between a dedicated venous stent and standard composite Wallstent-Z stent approach to iliofemoral venous stenting: Intermediate-term outcomes

Abstract

Objective: Dedicated venous stents have not been used in the management of symptomatic chronic iliofemoral venous obstruction (CIVO) until recently. The Bard Venovo stent (Becton, Dickinson, and Co, Franklin Lakes, NJ) is one such stent noted to have an increased chronic outward force and radial resistive force compared with the Wallstent (Boston Scientific, Marlborough, MA). In the present study, we evaluated the outcomes following the use of the Bard Venovo stent vs a matched cohort of limbs that had undergone stenting with the Wallstent-Zenith (Z) stent (Cook Medical Inc, Bloomington, IN) composite configuration.

Methods: A review of contemporaneously entered electronic medical record data for 167 patients (167 limbs) with initial iliofemoral stents placed from 2019 to 2020 for quality of life (QOL)-impairing CIVO that had failed conservative therapy was performed. The visual analog scale for pain score (score, 0-10), grade of swelling (score, 0-4), venous clinical severity score (score, 0-27), and the 20-item chronic venous insufficiency quality of life questionnaire instrument for QOL were evaluated before and after intervention to assess the effects of stenting. A Kaplan-Meier analysis was used to examine primary, primary-assisted and secondary stent patency, and analysis of variance with repeated measures was used to compare clinical outcomes.

Results: A total of 167 limbs had undergone Bard Venovo stenting (56 men and 111 women). Their median age was 61 years. The laterality was right and left in 70 and 97 limbs, respectively. Post-thrombotic syndrome was seen in 84 limbs and nonthrombotic iliac vein lesions/May-Thurner syndrome in 83 limbs. At 6 months, the venous clinical severity score had improved from 7 to 4 in the limbs with a unilateral Venovo (UV) stent and from 5 to 4 in the composite Wallstent-Z stent group (P = .9). The grade of swelling had improved from 3 to 1 in the UV group and from 3 to 1 in the composite group (P = .6), and the visual analog scale for pain score had improved from 7 to 2 in the UV group and from 5 to 0 in the composite group (P = .007). At 12 months, ulcers had healed in 53% (8 of 15) of the UV group and 56% (5 of 9) of the composite group (P = .7). The global 20-item chronic venous insufficiency quality of life questionnaire scores had improved from 58 to 28 in the UV group and from 59 to 40 in the composite group (P = .6). The cumulative primary, primary-assisted, and secondary patency at 18 months was 81%, 97%, and 98% in the UV group and 87%, 98%, and 100% in the composite group, respectively (P > .4). No difference in the reintervention rates was noted between the two groups (P = .5).

Conclusions: For patients who had undergone stenting for QOL-impairing CIVO, the results with the Bard Venovo venous stent were comparable to those with the composite Wallstent-Z stent configuration for clinical outcomes, QOL improvement, and stent patency. Further study is, however, required to confirm this improvement in the long term.

Keywords: Chronic venous insufficiency; Iliac vein obstruction; May Thurner syndrome; Non thrombotic iliac vein lesion; Post thrombotic syndrome; Venous stenting.