Improvement in Quality of Life After Iliac Vein Stenting in a Prospective Clinical Study of a Nitinol Venous Stent

Abstract

Stenting of the iliofemoral venous outflow tract is recommended to treat patients with significant limb symptoms related to obstruction. However, it remains unclear which patients benefit most from iliac vein stenting. In this prospective clinical trial studying the performance of a nitinol stent designed for the treatment of venous obstructive disease, quality of life (QOL) measures were related to patient and procedural characteristics to determine which patients benefit most from venous stenting. There were 170 patients with chronic iliofemoral venous obstruction enrolled in a prospective pivotal trial studying the effectiveness of a nitinol venous stent (Veniti, Inc, Fremont, Calif). Before intervention, QOL was measured with the Venous Clinical Severity Score (VCSS) and Chronic Venous Insufficiency Questionnaire (CIVIQ-2) score. Venography was performed, and the presence of vessel stenosis of >50% was required for study inclusion. Intravascular ultrasound (IVUS) was also performed before and after stent insertion to allow calculation of lumen diameter and area. QOL was measured with VCSS and CIVIQ-2 at 1 month, 6 months, and 12 months after stenting, and repeated venography and IVUS were performed at 12 months. Of the cohort, 140 had QOL measures performed before stenting and at 12 months of follow-up. Of these, 133 had IVUS measurements at the time of stent insertion and 94 had IVUS at 12 months. Both VCSS and CIVIQ-2 score improved significantly at 1 month and 12 months after stenting as noted in the Table. Improvement in VCSS was similar in patients treated for nonthrombotic (5.2 ± 5.6 points) and post-thrombotic (4.0 ± 3.9 points) disease. Patients who experienced significant improvement in VCSS (≥3 points; n = 91) had a significantly higher mean maximal area stenosis on IVUS before stenting (70.1% ± 20%) than 32 patients who had <2 points of improvement on VCSS (57.2% ± 25.9%; P = .007). VCSS improvement at 12 months did not correlate with the maximal percentage diameter or percentage area stenosis on IVUS at 12 months. The majority of patients treated with venous stenting for symptomatic iliofemoral venous obstruction experience significant reduction in symptoms that is durable to 12 months of follow-up. QOL improvement was significantly more frequent in patients stented for more severe venous obstruction.TableVenous Clinical Severity Score (VCSS) and Chronic Venous Insufficiency Questionnaire (CIVIQ-2) score at 1 month and 12 monthsBefore stenting1 month after stenting12 months after stentingP value before vs 1 monthP value before vs 12 monthsVCSS9.9 ± 5.06.3 ± 4.35.7 ± 4.3<.00001<.000001CIVIQ-20.44 ± 0.240.30 ± 0.250.27 ± 0.25<.00001<.00001 Open table in a new tab