ABSTRACT
OBJECTIVE: We compared the effectiveness and safety of polidocanol 1% endovenous microfoam ablation vs endovenous thermal ablation with radiofrequency or laser energy for treatment of venous insufficiency caused by lower extremity truncal vein incompetence via network meta-analysis of published comparative evidence. METHODS: We conducted a systematic literature review following best practices, including a prospective protocol. We screened studies published in English from 2000 to 2023 for randomized and nonrandomized studies reporting direct or indirect comparisons between polidocanol 1% endovenous microfoam and endovenous thermal ablation. Thirteen studies met our eligibility criteria for the network meta-analysis. The co-primary effectiveness outcomes were the closure rate ≥3 months after procedure and the average change in the Venous Clinical Severity Score. For the subgroup of venous ulcer patients, the ulcer healing rate was the primary effectiveness outcome. The secondary outcomes included safety and patient-reported outcomes. Network meta-analyses were conducted on outcomes having sufficient data. Categorical outcomes were summarized using odds ratios (ORs) with 95% confidence intervals (CIs). Sensitivity tests and estimates of network inconsistency were used to investigate the robustness of our meta-analysis. RESULTS: We found that polidocanol 1% endovenous microfoam was not significantly different statistically from endovenous thermal ablation for venous closure (OR, 0.65; 95% CI, 0.36-1.18; P = .16). Although not the primary aim of the study, the network meta-analysis also provided evidence to confirm our supposition that polidocanol 1% endovenous microfoam was significantly differentiated statistically from physician-compounded foam, with higher odds for vein closure (OR, 2.91; 95% CI, 1.58-5.37; P < .01). A sensitivity analysis using the longest available time point for closure in each study, with a minimum of 12 months of follow-up (median, 48 months; range, 12-72 months), showed results similar to those of the main analysis. No association was found between the risk of deep vein thrombosis and the treatment received. The available data were insufficient for a network meta-analysis of Venous Clinical Severity Score improvement and ulcer healing rates. CONCLUSIONS: Polidocanol 1% endovenous microfoam was not significantly different statistically from endovenous thermal ablation for venous closure and deep vein thrombosis risk for chronic venous insufficiency treatment, based on a network meta-analysis of published evidence. Polidocanol 1% endovenous microfoam was significantly differentiated statistically from physician-compounded foam, with higher odds of vein closure. A sensitivity analysis found venous closure findings were robust at follow-up intervals of 12 months or greater and for up to 6 years. New evidence meeting the inclusion criteria for this review will be incorporated at regular intervals into a living network meta-analysis.
ABSTRACT
OBJECTIVE: Severe presentations of chronic venous insufficiency can result from reflux or obstruction at the deep venous, perforator, or superficial venous levels. Iliofemoral venous stenting can be used to address central venous obstruction; however, its effects on deep venous reflux (DVR) have remained unclear. The purpose of the present study was to evaluate the effects of iliac vein stenting on femoropopliteal DVR with the hypothesis that ultrasound evidence of DVR would remain absent or would have improved after iliac vein stenting. METHODS: The present study was a retrospective review of patients who had undergone iliofemoral venous stenting from 2013 to 2018. The patients were divided into two cohorts according to the preprocedural presence (group A) or absence (group B) of femoropopliteal DVR. Baseline patient variables were collected, including age, gender, CEAP (clinical, etiologic, anatomic, pathophysiologic) class, presence of concomitant superficial or perforator reflux, deep vein thrombosis history, and additional venous interventions. The primary outcome evaluated was the persistent absence or resolution of DVR on the latest venous duplex ultrasound at follow-up. Other outcomes included the follow-up CEAP classification and the need for secondary deep venous interventions. RESULTS: A total of 275 consecutive patients had undergone iliofemoral venous stenting. Of the 275 patients, 58 had presented with DVR (group A). A comparison of groups A and B revealed that group A had had a greater likelihood of prior deep vein thrombosis (P = .0001) and a higher frequency of superficial venous ablation. The remaining demographic variables did not differ significantly between the two groups. Of the 58 patients in group A, DVR had resolved at follow-up in 17 (P = .0001). When stratified by level, 7 of these 17 patients had had isolated popliteal reflux. In group B, DVR had developed at follow-up in 6 of the 217 patients. The CEAP class had improved from before intervention (C0, 1.1%; C1, 0.4%; C2, 1.8%; C3, 41.4%; C4, 24.9%; C5, 5.9%; C6, 24.5%) to the latest follow up (C0, 4.9%; C1, 1.9%; C2, 5.7%; C3, 34.2%; C4, 22.8%; C5, 17.1%; C6, 13.3%). Significant improvement had occurred in C6 disease within both groups (group A, 16 of 58 [27.6%; P = .0078]; group B, 19 of 217 [8.8%; P = .0203]). CONCLUSIONS: For patients who undergo iliofemoral venous stenting, DVR could improve if present initially and is unlikely to develop if not present before stenting. A cohort of patients had experienced persistent DVR and warranted further evaluation. Prospective studies are required to corroborate the safety, efficacy, and durability of iliofemoral venous stenting for patients with DVR.
