Health Problem: Varicose veins, also known as varicosities, are a common manifestation of chronic venous insufficiency (CVI), a category of chronic venous disease (CVD). Varicose veins are enlarged and tortuous vessels (≥ 3 millimeters [mm] in diameter) that develop when the thin flaps of the venous valves no longer meet in the midline, thereby allowing blood to reflux, or flow backwards. Often, varicose veins initially present as a cosmetic concern, but they can become clinically important when symptoms such as cramping, throbbing, burning, swelling, feeling of heaviness or fatigue, and alterations in skin pigmentation in the afflicted area become pronounced.

Technology Description: Radiofrequency ablation (RFA) is the removal or destruction of a vein or vein segment by means of radiofrequency (RF) energy. Endovenous RFA is a treatment for symptomatic varicose veins that involves delivery of controlled RF energy through a catheter inserted into the affected vein. The heat generated by the RF energy causes the vein to contract and become occluded. This therapy is intended primarily for the treatment of varicose veins that result from great saphenous vein (GSV), small saphenous vein (SSV), or accessory vein reflux. The treatment is intended as a minimally invasive alternative to standard surgery for symptomatic varicosities.

Controversy: The availability of less invasive procedures such as RFA to treat varicose veins in outpatient settings, along with other factors, has correlated with an increase in the numbers of patients receiving treatment for varicose veins. Thus, there is a need to compare alternative treatments with conventional surgery for treating symptomatic varicose veins with respect to rates of retreatment and patient-centered outcomes. Relative costs, patient preference, and patient selection criteria are also contextual factors of interest to payers, providers, and patients.

Key Questions:

  • Among patients being treated for varicose veins, what is the clinical effectiveness of endovascular RFA compared with ligation with or without stripping?
  • Among patients being treated for varicose veins, what are the harms associated with endovascular RFA compared with ligation with or without stripping?
  • Have definitive patient selection criteria been established for the use of endovascular RFA in patients with symptomatic varicose veins?

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