Use of Objective Assessment Criteria to Assess Symptom Severity and Clinical Effectiveness After Deep Venous Stenting

Abstract

The objective was to identify measures used to assess symptom severity in patients before deep venous intervention and outcomes used to evaluate its clinical effectiveness. The study was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses. We searched MEDLINE for studies of stent placement for treatment of iliofemoral venous outflow obstruction using keywords including “venous,” “stent,” and “thrombosis.” The final search was conducted on December 1, 2019. Data were extracted from peer-reviewed articles by one author and verified by another. A database was developed, pilot tested, and refined to maintain consistency of the indications for intervention and the outcomes reported in the literature. There were 6356 patients with venous stents identified from 93 studies; 1300 patients (20%) were treated for acute thrombosis, and 5056 patients were treated for chronic venous insufficiency (CVI) due to nonthrombotic lesions (2200 patients [35%]) or post-thrombotic disease (2856 patients [45%]). The clinical component of the Clinical, Etiology, Anatomy, and Pathophysiology classification (CEAP) was reported in 3233 of 5056 CVI patients (64%) before intervention (C0, 2%; C1, 2%; C2, 7%; C3, 46%; C4, 21%; C5, 6%; C6, 16%). Stent patency was reported in all studies but with variable follow-up (6 months-5 years). Overall primary patency was 81% in 3365 patients, and secondary patency was reported as 95% in 4700 patients at 1 year. Of 655 patients with active ulceration, 397 (61%) healed during follow-up. The Venous Clinical Severity Score or revised Venous Clinical Severity Score was reported in 849 patients (13%). The overall average score was 8 before intervention and 3 after intervention. Villalta scores were reported in 768 patients (12%) before intervention and in 1111 patients (17%) after intervention. Average Villalta scores were 20 before intervention and 5 after intervention. Patency rates are consistently reported after deep venous stenting; however, the length of follow-up in published studies remains modest. The CEAP classification of CVI patients is unreported in more than a third of patients undergoing invasive treatments, which makes accurate comparison between individual studies challenging. Although apparently successful, few studies use objective measures to quantify the clinical effectiveness of deep venous stenting, and consensus is lacking on which is the most appropriate tool to use. More research is needed on the ideal assessment measures to identify suitable patients for these interventions and the best methods to qualify clinical effectiveness objectively.