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Juan Cabrera, MD; Juan Cabrera, Jr, MPharm; M^a Antonia García-Olmedo, DPharm; Pedro Redondo, MD, PhD

Arch Dermatol. 2003;139:1409-1416.

Background  Treatment of congenital venous malformations poses a major clinical challenge. Surgery is difficult and frequently unsuccessful, radiological intervention with embolization has an ill-defined role, and conventional sclerotherapy has little to offer.

Objective  To evaluate the efficacy and safety of sclerosant in microfoam form in treating congenital venous malformations.

Design  A retrospective study of medical records, pretreatment and posttreatment color photographs, echo-Doppler ultrasonographic results, and/or magnetic resonance imaging in patients with congenital vascular malformations of venous predominance. Follow-up ranged from 6 to 103 months (mean, 30 months).

Setting  Private vascular surgery clinic in Granada, Spain, and dermatology department at a university hospital in Pamplona.

Patients  The study population comprised 50 patients, 19 with limited venous malformations, 16 with infiltrating venous malformations, and 15 with Klippel-Trénaunay syndrome.

Intervention  Percutaneous sclerotherapy by direct injection of 0.25% to 4% polidocanol microfoam under du-plex ultrasonographic guidance. The number of sessions varied between 1 and 46 (mean, 12 sessions).

Main Outcome Measure  The primary efficacy end point was defined as a reduction in size after completion of the treatment.

Results  Sclerosis therapy with polidocanol microfoam was judged beneficial in 46 (92%) of the 50 patients. Among the 46 responders, 18 showed disappearance of treated malformations, 15 showed a reduction in malformation size of more than 50%, and 13 showed a reduction in malformation size of 50% or less. Of the 39 patients who presented with pain, the pain disappeared in 25 and was reduced in 14. No major adverse effects were reported by any patient. There were 4 cases of transient skin pigmentation and 3 cases of skin necrosis.

Conclusions  Color echo-Doppler ultrasonography–guided sclerotherapy with polidocanol microfoam was effective in 46 (92%) of the patients. The technique is delivered on a strictly ambulatory basis and has proved simple and innocuous. The quality and durability of the outcome make this novel procedure the treatment of choice in the care of patients with congenital venous malformations.

From the Vascular Surgery Clinic, Granada, Spain (Drs J. Cabrera and García-Olmedo and Mr J. Cabrera Jr; and the Department of Dermatology, University Clinic of Navarra, Pamplona, Spain (Dr Redondo). The microfoam presented in the study was the subject of a patent application by the authors in 1993, and they have subsequently assigned the patents to BTG International Limited, London, England. Provensis Ltd, London, a subsidiary of BTG International Limited, has developed the patented microfoam concept into a pharmaceutical product, Varisolve, which is undergoing clinical trials in Europe and the United States.

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