The treatment which works by heating the vein with high-pressure steam at 120°C is promising, van den Bos told delegates, but should be compared in a randomised trial with endovenous thermal therapies, such as laser or radiofrequency ablation.
The aim of the study was to assess the effectiveness of endovenous steam ablation of varicose veins in animal and human subjects. In sheep, safety was assessed by cardiovascular monitoring during treatment. Ultrasound was used to examine the decrease in vein diameter, and changes in treated veins were examined microscopically.
In a pilot study, 20 human patients with insufficiency of the great or the small saphenous vein were treated. Anatomical success, patients’ satisfaction and complications were investigated at one week, three and six months.
The results showed that all veins in the sheep were occluded, and there were no cardiovascular changes during treatment. Histological examination of treated veins showed typical changes of the vein wall, such as disappearance of the endothelial layer, fibrotic thrombosis, and major alterations in collagen fibres in the media. In the 20 patients, the steam ablation was successful; 13 of 20 veins were completely closed and seven showed a very small segment of recanalisation after six months of follow-up which did not seem to be of clinical relevance.
Nine of 20 patients had some ecchymoses at the puncture site, one patient had a transient superficial phlebitis, and a mean maximal pain score of 2,1 (0–10) was reported. No serious side effects were reported. Patients were very satisfied about the treatment with a mean satisfaction score of 9,1 (0–10).
