Treatment of the incompetent great saphenous vein by endovenous radiofrequency powered segmental thermal ablation: first clinical experience

Abstract

Background: Radiofrequency ablation of saphenous veins has proven efficacy with an excellent side effect profile but has the disadvantage of a lengthy pullback procedure. This article reports a new endovenous catheter for radiofrequency-powered segmental thermal ablation (RSTA) of incompetent great saphenous veins (GSVs).

Methods: A prospective, nonrandomized, multicenter study was conducted to evaluate the safety, feasibility, and early clinical outcomes of RSTA of the GSV.

Results: A total of 194 patients with 252 GSVs with an average diameter of 5.7 +/- 2.2 mm (range, 2.0 to 18.0 mm) received RSTA under tumescent local anesthesia. In 58 patients (29.9%), bilateral treatment (average length treated, 36.7 +/- 10.8 cm) was done. The average total endovenous procedure time was 16.4 +/- 8.2 minutes, and the average total energy delivery time was 2.2 +/- 0.6 minutes. The corresponding endovenous fluence equivalent delivered to the proximal 7-cm vein segment was 82 +/- 25 J/cm(2) (range, 38 to 192). Follow-up at 3 days, 3 months, and 6 months was obtained from 250, 164, and 62 limbs, respectively. Occlusion rates were 99.6% for all three follow-up dates according to life-table analysis. The average Venous Clinical Severity Score was 3.4 +/- 1.2 at 3 days, 0.9 +/- 1.6 at 3 months, and 1.5 +/- 1.8 at 6 months compared with 3.9 +/- 2.0 at baseline.

Conclusion: Radiofrequency segmental thermal ablation is feasible, safe, and well tolerated.