Cyanoacrylate Glue Great Saphenous Vein Ablation: Preliminary 180-Day Follow-Up of a First-In-Man Feasibility Study of a No-Compression-No-Local-Anesthesia Technique

Abstract

Background: Factors contributing to recurrence of varicose veins after thermal ablation are not well known. The goal of this prospective, non-randomized, multi-center trial was to determine the site, source, and contributory factors of varicose vein recurrence after radiofrequency (RF) and laser ablation.Methods: Seven centers enrolled patients into the study during a twelve-month period, from January 1st, to December 31st, 2010. All patients underwent previous thermal ablation of the great saphenous vein (GSV), small saphenous vein (SSV) or anterior accessory great saphenous vein (AAGSV). Patients with high ligation of the GSV and/or stripping were excluded from the study. From a specific designed study tool, recurrence was identified as to site, etiology, and primary mode of treatment (RF, laser).Results: 2,380 patients were evaluated during this time frame. A total of 164 patients, (7%), 3 with bilateral limb involvement, had varicose vein recurrence at a mean of 3 years after treatment (range, 9 months to 8 years) This group of 164 patients with varicose vein recurrence were the subjects of this study. 33% were between the age of 51 and 60, median age range was 51-60, and 83% were women. A history of deep venous thrombosis (DVT) was present in 2% of the patients and deep venous insufficiency was present in 17%. GSV ablation was the initial treatment in 159 patients (RF: 33, laser: 131, 52 of these patients had either SSV or AAGSV ablation concurrently. Total or partial GSV recanalization occurred in 47 patients (29%). Of these 47 patients, 27 had RF ablation, and 20 had laser thermal ablation. New AAGSV reflux occurred in 40 patients (24%), and new SSV reflux occurred in 24 patients (12%) Primary or associated perforator pathology was present in 64% of patients.Conclusions: Recurrence of varicose veins at 3 years after thermal ablation was 7%. The three most important factors associated with varicose vein recurrence included new or recurrent perforating veins; recanalized GSV and new AAGSV reflux, in decreasing frequency. In this study, patients who underwent RF treatment had a higher rate of GSV recanalization than those who were treated with laser.

Mechanochemical ablation: status and results

“…Other methods such as cyanoacrylate glue 9 or polidocanol endovenous microfoam 10 also accomplish saphenous closure without using tumescence. Long-term results of these methods are not currently published and clinical trials are ongoing.…”

Cyanoacrylate Superglue to Treat Varicose Veins: Truly Office Based and Minimally Invasive?

“…10, The results of 1year clinical follow-up on 38 patients who underwent treatment of their symptomatic varicose veins with cyanoacrylate glue injection into the long saphenous vein were published recently. 11,12 All the treated veins were closed at 24e72 h, and at 30 days, 97% of the veins were completely closed. There were no significant side effects or complications.…”

Experience in Sealing of Truncal Varicose Veins - Treatment of 2202 Truncal Veins in 1180 Cases a 79 Months Follow - Up Study

“…Also the surgeons of the "Golden Twenties" didn`t love the radical surgery! But today we have the ultrasound and all colleagues who work with endovenous procedures meanwhile have reliable criteria for a high -quality therapy [2][3][4][5][6][7][8][12][13][14][15][16][17]20,[24][25][26]. The VenaSeal® -closure procedure is the newest technical development in the series of endovenous therapeutic procedures.…”

“…At the beginning, the rather inconvenient VNUS® Closure Plus procedure and the more convenient linear laser procedure were used, and these were followed in 2006/2007 by the bipolar RFITT® catheter, the VNUS® ClosureFast system, and the radial laser. Thus, in the course of the last few years, plenty of experience has been gathered with endoluminal therapy, quality criteria have been defined and standards for the different techniques have been developed [1][2][3][4][5][6][7][8][12][13][14][15][16][17]20].…”