Treatment of Venous Malformations: First Experience with a New Sclerosing Agent—A Multicenter Study

Purpose: To show the advantage of high-viscous ethanol compared to simple pure alcohol.

Material and Methods: Though absolute ethanol has been proved to be highly effective in treatment of venous malformations, it remains difficult to manipulate as a result of its diffusible feature due to the low viscosity with diffusion into surrounding uninvolved vessels and tissue with a significant risk of major adverse effect. To avoid these risks while exploiting the efficacy of ethanol, the pure 96% substance (3.8 g) was mixed with ethylcellulose (a long-chain polymer) at a concentration of 5.88% (0.2 g), generating a higher viscosity of 330 cps. In vitro testing showed a prompt participation in NaCl or full blood but no gluing effect. Animal testing demonstrated that the material is not suitable for arterial injection because it passes the capillary bed. The substance was tested in a prospective nonrandomized multicentric ongoing study.

Results: To date, 77 patients (ages 4 to 46 yrs) have been treated in 158 sessions with different volumes ranging from 0.2 to 10 mL. The maximum number of single sessions was 4 in four patients with a mean of 1.8 sessions per patient. The systemic concentration of ethanol was measured in all patients not exceeding a maximum of 0.50 g/L, fulfilling in no case the criterion for legal intoxication. All patients suffered from venous malformation (mainly facial and in the neck as well as body and extremity malformations). More than 80% showed a significant reduction of the venous pouches. Adverse events happened locally in 12 patients (15%) permanently being in only 1 patient (facial paresis). Systemic transient reactions were bradycardia in 1 patient and nausea in 4 patients.

Conclusion: The results show in summary an easy handling of the substance, safe application, low rate of systemic effects, and high efficiency due to good target injection.