Radiofrequency Ablation vs. Laser Ablation of the Incompetent Small Saphenous Vein

Chronic venous insufficiency (CVI) is estimated to affect 25 million Americans. This
condition leads to varicose veins, aching, fatigue, swelling, ulcerations, and bleeding in
the lower extremities. The second most common cause is a refluxing or incompetent Small
Saphenous Vein (SSV). This condition results in pooling of deoxygenated blood in the lower
extremities rather than successful transport of the blood back to the heart and lungs. The
historical treatment has been to surgically remove or 'strip' the SSV so that blood is
rerouted through the healthier deep veins. A less invasive treatment option, Endovenous
Thermal Ablation, has emerged over the last decade and has virtually replaced stripping. This
involves advancing a catheter under ultrasound guidance through the SSV and then advancing a
laser fiber or radiofrequency probe through the catheter. These devices then produce the
energy to destroy the vein as the catheters are slowly pulled back. While both radiofrequency
ablation and laser ablation are accepted treatments, neither technology has been definitively
proved to have fewer complications or superior results. This is in part because very few
practices have the ability to make a head to head comparison between the two technologies and
must choose one or the other secondary to financial constraints. The aim of this study is to
perform a randomized prospective trial comparing the two modalities so that more definitive
information to evaluate complications and outcome can be obtained and then recommendations on
which, if either, technology is superior can be made.

Inclusion Criteria:

- Patients with symptomatic chronic venous insufficiency.

- Patients in whom endovenous thermal ablation is clinically indicated.

- Have previously undergone at least 6 weeks of conservative treatment with compression
stockings (unless they have venous ulcers, recurrent phlebitis, or bleeding varices).

- Have symptoms secondary to Small Saphenous Vein insufficiency defined as reverse flow
in the saphenous vein >0.5 seconds after calf compression or while standing.

Exclusion Criteria:

- Have previously undergone surgery, EVTA, or phlebectomy in that extremity (exclusive
of spider vein injections or other cosmetic surface procedures).

- Have a history of Deep Venous Thrombosis (DVT).

- Have a history of hypercoaguability disorder.

- Are pregnant or breastfeeding.

- Are nonambulatory.