Background: Treatment of congenital venous malformations poses a major clinical challenge. Great successes have been achieved with ethanol sclerotherapy in most lesions; however, severe complications are more likely to occur when more ethanol is used.
Objectives: This study evaluated the safety and efficacy of a new sclerotherapy treatment that uses absolute alcohol and bleomycin A5. We evaluated our experience to present a safe treatment method for venous malformations.
Methods: The study population comprised 201 patients. Before treatment, lesions were categorized according to magnetic resonance imaging features: 120 patients had limited venous malformations, and 81 had infiltrating venous malformations. Percutaneous sclerotherapy was performed by direct injection of absolute alcohol and bleomycin A5 under fluoroscopy. The mean dose of the two medicines was 3.4 mL and 3.7 mg, respectively. We investigated 592 sclerotherapy sessions. A retrospective study was performed of medical records and color photographs and magnetic resonance imaging before and after treatment The mean follow-up was 29 months (range, 12-65 months).
Results: After embolization of the drainage vein with ethanol, a subsequent sclerosis therapy with bleomycin A5 was judged beneficial in 196 of 201 patients. Among the 196 responders, 56 showed disappearance of their chief symptoms, 42 showed improvement to nearly normal, and 62 showed marked improvement. The best response to our treatment was among the patients with limited venous malformations, with 114 (95%) showing at least marked improvement. Complications were tissue necrosis in 6 sessions, peripheral nerve palsy in 5, pigmentation in 10, blistering in 5, and 87 sessions resulted in transient side effects related to bleomycin A5, such as fever and gastrointestinal irritation. All were self-limited. No major complications such as cardiopulmonary collapse or pulmonary fibrosis were observed.
Conclusion: Percutaneous sclerotherapy of venous malformations using absolute ethanol and bleomycin A5 is safe and effective. The simplicity, speed, and safety of sclerotherapy, combined with the quality and stability of the outcome achieved with our novel procedure, may make the technique the choice for treatment of venous malformations.