Summary

Background: Radiofrequency powered segmental thermal ablation Closure FAST has become a globally engaged technology for ablation of incompetent great saphenous veins (GSVs). Mid-term results of slowly resolving side effects are still not described. Methods: RSTA-treated GSVs (n = 295) were followed for 24 months in a prospective multicenter trial. Clinical control visits included flow and reflux analysis by duplex-ultrasound and assessment of treatment related side effects at all times. Results: 280 of 295 treated GSVs (94.9%) were available for 24 months follow-up. According to the method of Kaplan and Meier at 24 months after the intervention 98.6% of treated legs remained free of clinically relevant axial reflux. The average VCSS score improved from 3.9 ± 2.1 at screening to 0.7 ± 1.2 at 24 months follow-up (p < 0.0001). While only 41.1% of patients were free of pain before treatment, at 24 months 99.3% reported no pain and 96.4% did not experience pain during the 12 months before. At 24 months n=3 legs showed pigmentation along the inner thigh and one leg showed study-treatment related paresthesia. Conclusion: Radiofrequency powered segmental thermal ablation Closure FAST showed a very moderate side-effect profile in conjunction with a high and durable clinical success rate.