Cryoablation of Venous Vascular Malformations

In order to propose an additional alternative option, cryoablation has been recently tested with promising results. Therefore, the purpose of this study is to evaluate the safety and efficacy of cryotherapy on venous vascular malformations.

Fourteen patients will be included after discussion in multidisciplinary meeting. Patients will be follow until 6 months to evaluate the safety and the 6 months efficacy on symptoms. A MRI will be perform at 6 months to evaluate the size of ablated zone following RECIST criteria.

Inclusion criteria

• Patient over 18 years,
• Initial radiological diagnosis of venous or glomovenous vascular malformation proved by Doppler ultrasound and MRI,
• Recurrence of symptoms after initial treatment,
• Symptomatic deformation :pain, tangible mass,functional discomfort
• Recurrence after treatment by surgery or sclerosis
• Cryotherapy considered technically feasible after discussion in multidisciplinary committee,
• Localization at distance from the skin and major neurovascular structures,
• Absence of contra-indication of anaesthesia,
• Signed informed consent,
• Coverage by French social security

Exclusion criteria

• Localization of the lesion does not allow the implementation of cryotherapy in adequate conditions: ablation zone too close to the major anatomic structures (nerve),
• TP <50% TCA> 1.5 x control, anticoagulation
• Platelets <90000/mm3,
• Progressive infection
• Patient included in another clinical study,
• Unable to undergo medical tests for geographical, social or psychological,
• Adult under a legal guardianship or unable to consent,
• Pregnancy and breastfeeding.