A retrospective study of a new n-butyl-2-cyanoacrylate glue ablation catheter incorporated with application guiding light for the treatment of venous insufficiency: Twelve-month results

Abstract

Objective This study aims to present the early results of a retrospective study of the use of novel n-butyl-2-cyanoacrylate (VenaBlock)-based nontumescent endovenous ablation with a guiding light for the treatment of patients with varicose veins. Methods Patients with lower limb venous insufficiency were treated with n-butyl-2-cyanoacrylate (VenaBlock Venous Closure System) between April 2016 and July 2016. The study enrolled adults aged 21-70 years with symptomatic moderate to severe varicosities (C2-C4b) and great saphenous vein reflux lasting longer than 0.5 s with great saphenous vein diameter between 5.5 and 15 mm assessed in the standing position. No compression stockings were used after the procedure. Duplex ultrasound imaging and clinical follow-up were performed on the third day, first month, sixth month, and 12th month. Clinical, etiological, anatomical, pathophysiological classification; venous clinical severity score; and completed Aberdeen varicose vein questionnaire were recorded. Results Five hundred thirty-eight patients with great saphenous vein incompetency underwent n-butyl-2-cyanoacrylate ablation. The mean ablation length was 25.69 ± 4.8 cm, and the average amount of n-butyl-2-cyanoacrylate delivered was 0.87 ± 0.15 ml. The mean procedure time was 11.7 ± 4.9 min. Procedural success was 100%, and complete occlusion was observed after treatment and at the third-day follow-up. We observed ecchymosis in five patients (1.00%) at the entry site at the third-day follow-up. Phlebitis was encountered with six (1.20%) patients. No skin pigmentation, hematoma, paresthesia, deep vein thrombosis, or pulmonary embolism was observed. Kaplan-Meier analysis yielded an occlusion rate of 99.4% at the 12-month follow-up. All patients had significant improvement in venous clinical severity score and Aberdeen varicose vein questionnaire scores postoperatively ( p <0.0001). Venous clinical severity score scores decreased from 5.43 ± 0.87 to 0.6 ± 0.75. Aberdeen varicose vein questionnaire scores decreased from 18.32 ± 5.24 to 4.61 ± 1.42. Conclusions The procedure appears to be feasible, safe, and efficient in treating the great majority of incompetent great saphenous veins with this technique.

Efficacy of Cyanoacrylate Glue Ablation of Primary Truncal Varicose Veins Compared to Existing Endovenous Techniques: A Systematic Review of the Literature

“…37 Adjunctive treatments (phlebectomy or foam sclerotherapy) risk a type 2 error and the confounding potential of these treatments is a subject of future trials. 10,12,13,19,20,[25][26][27]29,33 There were outliers that skewed the NBCA occlusion data at 6 months and 1 year, leading to a dip in success rate at these intervals. 25,26,30 Bissacco et al reviewed 1,000 NBCA cases in seven studies (two prospective, four retrospective) and found 96.8% of veins occluded at 12 months.…”

“…25,26 Three studies documented minor point bruising at the access site of NBCA delivery catheter due to residual NBCA being applied close to the entry point. 27,31,33 Bleeding and hematoma formation were reported in one patient who underwent NBCA ablation and two post-RFA, the latter being at the site of vein access. 19,30 Paresthesia was temporary and less frequent in the NBCA group.…”

“…25,26 Another reported a modification of intervention after commencement of data collection which improved the complication rate in the remaining patients. 27 Blinding of assessors was not possible. The loss to follow-up for NBCA was 23.7% in one manuscript.…”

“…10,19,20,22,[29][30][31] One study used VenaBlock adhesive (Invamed, Ankara, Turkey). 27 The rest utilized the VenaSeal system (Medtronic, Dublin, Ireland). 12,13,21,25,26,28,[32][33][34] All procedures commenced by cannulation of the target vein with an introducer needle under ultrasound guidance at the most distal point of reflux.…”

“…All endovenous ablation modalities exhibited a statistically significant decline in VCSS scores over time. 10,12,19,20,22,[25][26][27][28][29]31,33,34 Two RCTs reported no difference between NBCA and EVLA during follow-up and another favored NBCA at 2 years (p < 0.001). 10,19,22 Two prospective analyses by Gibson and Park were analyzed separately because they used the revised version of VCSS.…”