Two-year follow-up of first human use of cyanoacrylate adhesive for treatment of saphenous vein incompetence

Abstract

Objectives: To evaluate the safety and effectiveness of endovenous cyanoacrylate-based embolization of incompetent great saphenous veins.

Methods: Incompetent great saphenous veins in 38 patients were embolized by cyanoacrylate bolus injections under ultrasound guidance without the use of perivenous tumescent anesthesia or graduated compression stockings. Follow-up was performed over a period of 24 months.

Result: Of 38 enrolled patients, 36 were available at 12 months and 24 were available at 24 months follow-up. Complete occlusion of the treated great saphenous vein was confirmed by duplex ultrasound in all patients except for one complete and two partial recanalizations observed at, 1, 3 and 6 months of follow-up, respectively. Kaplan-Meier analysis yielded an occlusion rate of 92.0% (95% CI 0.836-1.0) at 24 months follow-up. Venous Clinical Severity Score improved in all patients from a mean of 6.1 ± 2.7 at baseline to 1.3 ± 1.1, 1.5 ± 1.4 and 2.7 ± 2.5 at 6, 12 and 24 months, respectively (p < .0001). Edema improved in 89% of legs (n = 34) at 48 hours follow-up. At baseline, only 13% were free from pain. At 6, 12 and 24 months, 84%, 78% and 64% were free from leg pain, respectively.

Conclusions: The first human use of endovenous cyanoacrylate for closure of insufficient great saphenous veins proved to be feasible, safe and effective. Clinical efficacy was maintained over a period of 24 months.

Trial registration: ClinicalTrials.gov NCT01603433.

Keywords: Endovenous technique; endovenous laser treatment; endovenous thermal ablation; saphenous vein; varicose veins Registration: This trial was registered in May 2012 (before enrollment began) on clinicaltrials.gov: NCT01603433.