Balloon sclerotherapy: A new method for the treatment of truncal varicose veins

Background: Truncal varicose veins may be treated by conventional surgery or endovenous therapy. Endovenous ablation, such as laser or radiofrequency treatment, is less invasive but technically demanding, not cheap and has still the possibility of important side-effects. Moreover the treatment requires in the best case tumescent anesthesia. Catheter based endovenous sclerotherapy has the potential of systemic effects of sclerosing agent and air. We therefore aimed to develop a simple, minimal- invasive and cheap method for the treatment of truncal varicose veins reducing the potential risk of systemic effects of the sclerosing agent to a minimum. Methods: A double lumen double balloon catheter was developed. Thereby a treatment site within a vein can be isolated from blood for localized administration of a sclerotherapeutic agent. Later, a substantial portion of the therapeutic agent can be removed from the isolated segment thus minimizing the amount necessary. Occlusion of longer varicose segments is achieved by pointwise repetition of the manoeuvre or careful retraction of the expanded balloons with the "catched" sclerotherapeutic agent in between. Results: The application was filed as United States Patent No. 6,726,67 B2. 18 balloon prototypes successfully passed an extensive test series (leak tests, dimension tests, mandrel -, guide wire - and introducer compatibility tests, destructive tests). Three patients with varicosity of the greater saphenous vein and the vena saphena accessoria lateralis, respectively, were successfully treated with complete occlusion of the vessels 10, 6 and 2 months after the intervention. Conclusions: Balloonsclerotherapy combines two well-established procedures (balloon catheter therapy and sclerotherapy, namely) and promises to be a minimal-invasive and cheap endovenous therapy of truncal varicose veins, requiring local anesthesia at the puncture site only and reducing possible systemic side effects of the sclerosing agent.