A Randomised Controlled Trial Comparing Three Different Radiofrequency Technologies: Short-Term Results of the 3-RF Trial

Abstract

This paper demonstrates a clear difference between radiofrequency thermal ablation outcomes, with endovenous radiofrequency (EVRF) having significantly greater early failures (6 months) than Venefit and radiofrequency induced thermal therapy (RFITT). The paper also demonstrates the safety of the routine practice of starting ablation within 5 mm of the saphenofemoral junction (SFJ). The commonly cited (but little evidenced) ! 2 cm clearance from the SFJ is not backed by research studies and exposes patients to long-term risk of recurrence from junctional tributaries. It is hoped that this paper will stimulate research directed at this aspect of thermal ablation treatment. Objective: To date there has been no comparison of outcomes of endovenous radiofrequency (RF) devices. The 3-RF trial is the first randomised controlled trial of three commercially available RF ablation technologies. Methods: Patients were recruited [182/302 patients with great saphenous vein (GSV) incompetence] into a prospective double blind randomised trial of Venefit, radiofrequency induced thermal therapy (RFITT), and endovenous radiofrequency (EVRF). The primary outcome measure was GSV closure (total/partial/failed) at six months. Secondary outcome measures included ablation times, complications, pain scores, analgesia requirements, and quality of life (QoL) scores to 12 months. Results: Patients treated [180: Venefit (57), RFITT (64), EVRF (59)] were matched for age, sex, and vein characteristics. At six months, complete GSV closure was significantly better after Venefit and RFITT treatment (100% and 98%, respectively) compared with EVRF treatment (79%, p < .001). Mean treatment time was significantly faster for RFITT than for Venefit and EVRF (p < .0001). Euroqol 5D (EQ5D) visual analogue score (VAS) did not differ between groups at any time point. The only difference between groups in EQ5D domain scores was for the pain/discomfort domain at two weeks when significantly fewer EVRF patients reported no problems compared with Venefit and RFITT. This difference had disappeared at six and 12 months. The Aberdeen Varicose Vein Questionnaire (AVVQ) improved for all groups at six and 12 months compared with pre-treatment levels; however, there was no significant difference between groups. Conclusion: Compared with Venefit and RFITT, EVRF was associated with significant failure of truncal ablation at six months; however, clinical outcomes did not differ significantly at 12 months. clinicaltrials.gov identifier:

Editor's Choice – European Society for Vascular Surgery (ESVS) 2022 Clinical Practice Guidelines on the Management of Chronic Venous Disease of the Lower Limbs

“…At six months, complete GSV occlusion was better after segmental RFA and RFITT (100% and 98%, respectively) than after endovenous radiofrequency treatment (79%, p < .001). 182 110), both EVTA techniques produced comparable results with respect to treatment success (vein occlusion or abolition of reflux) at one year (92% for high dose EVSA and 96% for EVLA). 183 In a small prospective multicentre study, the occlusion rate was 96% at six months after EVSA.…”

Ablation of the great saphenous vein with F-care versus Closurefast endovenous radiofrequency therapy: Double-blinded prospective study

“…7 Oneyear occlusion rate of the Closurefast is about 94%. 8 However, one-year occlusion rate of F-care was about 89% according to Spiliopoulos et al, and six-month occlusion rate was 79% according to Nyamekye et al 5,6 This study shows the one-year occlusion rate of F-care was around 71.7% and ıt is 90.6% for Closurefast. The one-month occlusion rate was 96.2%-98%, respectively.…”

“…5 Other disadvantages of the F-care system is the adherence of tissue (presumed to be endothelium) to the catheter tip during the process that may cause more inferior energy transfer and closure rates. 6 We experienced the stickiness feeling in a couple of patients. The manufacturer claimed that there is no need for applicator removal for tip cleaning and we continued the treatments without cleaning the catheter tip.…”

“…5 This mechanism provokes plasma protein coagulation. 5,6 The catheter tip has to be pulled 0.5 cm every 5-6 s (tree beep). This mechanism makes the process slower when compared to Closurefast.…”

Radiofrequency Venous Ablation: Not Simple and Not Always Effective!

“…The study by 1 reports the success rates of three different radiofrequency devices for great saphenous vein (GSV) ablation. The senior author, who performed all the interventions himself, developed an algorithm (based on the parameters of successful ablation in earlier cases) for retreating some vein segments depending on their diameter.…”