UM Guidelines
Cyanoacrylate Adhesive,  Varicose Vein Treatment  

Ambulatory Care (AC)

BCBST last reviewed July 31, 2021*

Added Clinical Indications for Procedure:
   
 
  • Cyanoacrylate adhesive (VenaSeal™) may be indicated for ALL of the following:
    • There is demonstrated saphenous reflux and CEAP [Clinical, Etiology, Anatomy, Pathophysiology] class C2 or greater
    • Treatment is for truncal veins (i.e., great saphenous, small saphenous, accessory saphenous veins)
    • There is documentation of 1 or more of the following:
      • Ulceration secondary to venous stasis
      • Recurrent superficial thrombophlebitis
      • Ruptured superficial varicosity causing hemorrhage or recurrent bleeding episodes
      • Symptoms persist (i.e., pain, itching, burning) after 3 months of conservative therapy

Evidence Summary

Background

A cyanoacrylate adhesive is a clear, free-flowing liquid that polymerizes in the vessel via an anionic mechanism (i.e., polymerizes into a solid material on contact with body fluids or tissue). The adhesive is gradually injected along the length of the vein in conjunction with ultrasound and manual compression. The acute coaptation slows blood flow through the vein until the implanted adhesive becomes fibrotically encapsulated and establishes chronic occlusion of the treated vein. Cyanoacrylate glue has been used as a surgical adhesive and sealant for a variety of indications, including gastrointestinal bleeding, embolization of brain arteriovenous malformations, and surgical incisions or other skin wounds.

Criteria

Evidence assessing cyanoacrylate adhesive (CAC) for the treatment of varicose veins and venous insufficiency includes a multicenter noninferiority trial with follow-up through 36 months, an RCT with follow-up through 24 months, and a prospective cohort with 30 month follow-up. The short-term efficacy of VenaSeal CAC has been shown to be noninferior to RFA at up to 36-month follow-up. At 24 and 36 months the study had greater than 20% loss to follow-up, but loss to follow-up was similar in the two groups at the long-term follow-up and is not expected to influence the comparative results. A second RCT (n=525) with the same active CAC ingredient (N-butyl cyanoacrylate) that is currently available outside of the U.S. found no significant differences in vein closure between CAC and thermal ablation controls at 24-month follow-up. The CAC procedure and return to work were shorter and pain scores were lower compared to thermal ablation; the subjective pain scores may have been influenced by differing expectations in this study. A prospective cohort reported high closure rates at 30 months. Overall, results indicate that outcomes from CAC are at least as good as thermal ablation techniques, the current standard of care.

References

  1. BlueCross BlueShield Association. Evidence Positioning System. (6:2020). Treatment of varicose veins/venous insufficiency. (7.01.124). Retrieved August 31, 2020 from http://www.evidencepositioningsystem.com (63 articles and/or guidelines reviewed)
  2. Sarac, A.A. (2019). Two-year follow-up of a n-butyl-2-cyanoacrylate glue ablation for the treatment of saphenous vein insufficiency with a novel application catheter with guiding light. Vascular, 27 (4), 352-358. Abstract retrieved November 21, 2019 from PubMed database.