LEV 2. Preliminary First in Human Ultrasound-Guided High-Intensity Focused Ultrasound Treatment in Superficial Lower Limb Veins

Abstract

High-intensity focused ultrasound (HIFU) is an alternative to surgery or other thermal methods widely used in the treatment of thyroid, breast fibroadenoma, and uterine fibroma. HIFU generated by the Echopulse (Theraclion, Malakoff, France) device penetrates through tissues and causes localized hyperthermia responsible for irreversible protein denaturation and vein wall coagulation, whereas overlying and surrounding tissues are spared by focusing a beam into a given target. A focused transducer (3 MHz frequency) generates the ultrasound field. An imaging array of 7.5 MHz is centrally integrated to allow perfect alignment between the real-time imaging and the focal point. A first in human prospective study is ongoing, and patients were observed up to 3 months. We have several examples of positive results that are currently available. Most of the cases were performed without anesthesia and were well tolerated, and no severe adverse events were observed. A female patient presenting with recurrence after great saphenous vein (GSV) stripping received 12 pulses with a mean power of 45 W. No anesthesia was performed. The treated area was occluded acutely, and this result persisted at 3 months. A female patient presenting with a refluxing stump and neovascularization after GSV stripping as well as an active ulcer was treated at the groin level, over the stump and area of the neovessels. Ten pulses were delivered with a mean power of 42.9 W. No anesthesia was performed. The recurrent flow was abolished, and the ulcer was healed at 3 months. A male patient presenting with a refluxing calf perforator was treated after unsuccessful surgery and sclerotherapy. Nine pulses were delivered at a mean power of 45 W. No anesthesia was performed. The perforator was occluded acutely, and this result persisted at 3 months. A male patient presenting with a refluxing GSV and active ulcer was treated after surgery. Thirty-nine pulses were delivered with a mean power of 38 W. Tumescent anesthesia was performed. The vein was occluded acutely, and this result persisted at 3 months. The ulcer was healed at 3 months. In this first study using HIFU, the preliminary results are encouraging and show that HIFU could become a credible alternative method. In future studies, more cases and longer follow-up will be needed.