Radiofrequency Ablation vs Laser Ablation of the Incompetent Greater 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 most common cause is a refluxing or incompetent Greater Saphenous
Vein (GSV). 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 GSV 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 GSV 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 indicate.

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

- Have venous disease that meets CEAP clinical class 2 through 6.

- Have symptoms secondary to Greater 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 DVT.

- Have a history of hypercoaguability disorder.

- Are pregnant or breastfeeding.

- Are nonambulatory.