Health Problem: Varicose veins are dilated, thickened, elongated, and twisted blood vessels that may appear thread-like or as grape-like clusters under the skin, most often on the legs. They are manifestations of chronic venous insufficiency, a condition characterized by dysfunction of the valves in veins, leading to increased blood pressure, blood pooling, and venous reflux in affected areas. Varicose veins of the lower limbs are most often caused by incompetence and reflux of the great saphenous vein (GSV) and its accessory veins. Varicose veins may be asymptomatic, or the associated venous insufficiency may cause heaviness, fatigue, aching, burning, throbbing, numbness, cramping, swelling, itching, rash, discoloration, and ulceration of the affected limb. In addition, risk is increased for thrombophlebitis, deep vein thrombosis, and pulmonary embolism.
Technology Description: The polidocanol endovenous microfoam (PEM) 1% evaluated in this report is a prescribed proprietary canister (Varithena; BTG International, Ltd., a Boston Scientific Company) that generates a sterile, uniform, stable, low-nitrogen polidocanol 1% microfoam sclerosant intended for ultrasound-guided intravenous injection for treating venous incompetence and varicosities.
Controversy: Traditionally, vein stripping has been used to treat varicose veins. Alternative methods have been sought as stripping requires general or spinal anesthesia; increases risk for saphenous nerve injury; may result in substantial postoperative pain, hematoma, and recovery time; and has a high recurrence rate. Ablation techniques generally lead to better cosmetic outcomes, less pain, and shorter recovery periods than surgery. Endovascular thermal ablation has largely replaced stripping for treating larger and deeper veins. However, thermal ablation requires tumescence anesthesia and specialized equipment and training, increases risk of damage to normal adjacent tissue, and is associated with relatively common recurrence.
Is PEM 1% (Varithena) effective in treating venous incompetence and varicosities?
How does PEM 1% compare with sclerotherapy using alternative agents, surgery, coil embolization, endovenous thermal ablation, mechanochemical endovenous ablation, or endovenous adhesive?
Is PEM 1% safe?
Have definitive patient selection criteria been identified for PEM 1%?
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