Thirty-sixth-month follow-up of first-in-human use of cyanoacrylate adhesive for treatment of saphenous vein incompetence.

OBJECTIVE: The objective of this study was to evaluate the long-term safety and effectiveness of endovenous cyanoacrylate (CA)-based closure of incompetent great saphenous veins.

METHODS: This was a prospective, single-arm, single-center feasibility study conducted at the Canela Clinic (La Romana, Dominican Republic) to assess the effectiveness and safety of a CA-based adhesive for great saphenous vein closure at 36 months after treatment. Thirty-eight subjects were treated by injection of small boluses of CA under ultrasound guidance and without the use of perivenous tumescent anesthesia or postprocedure graduated compression stockings. Periodic scheduled follow-up was performed during 36 months.

RESULTS: At month 36, there were 29 subjects who were available for follow-up. Complete occlusion of the treated veins was confirmed by duplex ultrasound in all subjects with the exception of two subjects showing recanalization at month 1 and month 3. Kaplan-Meier analysis revealed an occlusion rate at month 36 of 94.7% (95% confidence interval, 87.9%-100%). The mean Venous Clinical Severity Score (VCSS) improved from 6.1 ± 2.7 at baseline to 2.2 ± 0.4 at month 36 (P < .0001). Pain, edema, and varicosities (VCSS subdomains) improved in 75.9%, 62.1%, and 41.4% of subjects, respectively, at month 36. Overall adverse events were mild or moderate and self-limited.

CONCLUSIONS: CA adhesive appears to be an effective and safe treatment for saphenous vein closure, with long-term occlusion rates comparable to those of other thermal and nonthermal methods and with no reported serious adverse events.