Six Year Extension Study of Patients From a Randomised Clinical Trial Comparing Venefit, Radiofrequency Induced Thermal Therapy, and Endovenous Radiofrequency Ablation for Treatment of Incompetent Great Saphenous Veins.

OBJECTIVE: To compare long term outcomes after great saphenous vein (GSV) treatment with three radiofrequency (RF) thermal devices: Venefit (Closurefast), Radiofrequency Induced Thermal Therapy (RFITT), and Endovenous Radiofrequency (EVRF). DESIGN: A 72 month follow up of patients who were treated in the randomised 3RF study. METHODS: A total of 172 participants from the 3RF study were invited to take part in a single visit, long term, follow up study. Failure of GSV closure was assessed with duplex ultrasound (DUS) and constituted the primary outcome. Patients completed questionnaires for secondary outcomes: Aberdeen Varicose Vein Questionnaire (AVVQ), Euroqol 5D (EQ-5D), and patient reported varicose veins measured by counting vein occupying boxes in AVVQ question 1. RESULTS: Twenty-two patients (12%) had already been re-treated. Of the remainder, 13 (7%) could not be contacted, 20 (11%) declined invitation, and one did not consent. Therefore, 116 (64%) and 95 (53%) participants completed questionnaires and DUS, respectively. Failure of GSV closure on 72 month DUS was 16%, 21%, and 37% for Venefit, RFITT, and EVRF, respectively (p = .14), whilst outcomes for all failures were 14%, 17%, and 44% (p < .001) (Venefit vs. EVRF: p < .001; RFITT vs. EVRF: p < .001; and Venefit vs. RFITT: p = .63). There were no between group differences in AVVQ or EQ-5D scores. Rates of patient reported presence of any varicose veins were high for all groups (97%, 92%, and 97% after Venefit, RFITT, and EVRF, respectively; p = .48). The EVRF treated participants reported more extensive recurrence than the Venefit and RFITT participants (p = .008). CONCLUSION: Long term technical outcomes after RF ablation for GSV varicose veins were significantly better after Venefit and RFITT compared with EVRF treatment. However, quality of life scores showed no differences after 72 months. Rates of patient reporting any varicose veins were high for all treatments. CLINICALTRIALS: gov Identifier: NCT04720027.

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

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: NCT02441881, NHS Health Research Authority (Hampstead Research Ethics Committee) number: 14/LO/1232.

A practical approach to tumescent local anaesthesia in ambulatory endovenous thermal ablation.

BACKGROUND: Thermal ablation, usually performed with tumescent local anaesthesia (TLA), is the preferred method for varicose veins treatment. Tumescent local anaesthesia is always cited; however, little detail of the procedure is presented in publications. This retrospective audit of clinical tumescent local anaesthesia practice aims to provide detailed information on an important aspect of endovenous practice. METHODS: Patients who underwent three types of endothermal treatment (Venefit, Radiofrequency Induce Thermal Therapy and Endovenous Laser Ablation) to a single saphenous trunk using tumescent local anaesthesia were assessed. Differences in tumescent local anaesthesia volume per unit length of treated vein were assessed for the followings: type of saphenous trunk, length of vein treated, effect of additional phlebectomy and bilateral versus interval unilateral treatment for bilateral veins. Descriptive data are reported as mean and standard deviation, and groups were compared using the one-way ANOVA test. RESULTS: Between 2008 and 2014, single-saphenous-trunk ambulatory TLA thermal ablation was performed in 979 patients, mean age was 54 years. A total of 1229 limbs had truncal ablations and synchronous phlebectomy was performed in 470 limbs. No tumescent local anaesthesia-related complications occurred. There was no significant difference in standardised tumescent local anaesthesia volume per centimetre (ml) used for the three devices. Tumescent local anaesthesia volume per centimetre (ml) differed significantly between saphenous trunks. On average, a standard 10-12 ml/cm of tumescent local anaesthesia was used for saphenous trunks. Mean total tumescent local anaesthesia volume per patient, when treating the great saphenous vein alone, was 931 ml for bilateral and 425 ml for unilateral treatment. CONCLUSION: This report of over 1000 endovenous procedures demonstrates safe performance of laser and radiofrequency treatments using tumescent local anaesthesia. Although no attempt was made to determine minimum volume requirements, a mean tumescent local anaesthesia volume of 10-12 ml/cm administered to the perivenous space provides adequate anaesthesia for truncal saphenous ablation.

Radiofrequency ablation of varicose veins: Best practice techniques and evidence.

SCOPE OF THE REVIEW: This article systematically reviews the practice of radiofrequency ablation of lower limb varicose veins. We present the clinical evidence and best practice techniques for currently available devices. METHODS: Manufacturer's instructions-for-use were requested for all radiofrequency devices. The MEDLINE and EMBASE databases were searched using the following keywords: 'varicose veins' AND 'radiofrequency' OR 'radio frequency' OR 'Venefit' OR 'ClosureFAST' OR 'RFiTT' OR 'EVRF' OR 'VeinCLEAR', generating 240 articles. Titles and abstracts were screened, yielding 63 articles directly relevant to the scope of the review. Reference lists for publications were also searched to identify further manuscripts of relevance. The Cochrane Database and current National Institute for Clinical and Healthcare Excellence guidelines for varicose veins were also searched from relevant articles. RESULTS: Four radiofrequency ablation (RFA) systems are currently commercially available. Generic practice methods (common to all RF systems) and device-specific techniques are described. The weight of current evidence relates to the use of Covidien Venefit™ (formerly VNUS ClosureFAST™), which clearly demonstrates clinical advantages over open surgery at least to 2 years follow up. However, contemporary studies of the radiofrequency-induced thermal therapy device (RFiTT®), show that in experienced hands, clinical equivalence to the Venefit™ procedure can be achieved. The evidence base for EVRF® and VeinCLEAR™ devices is currently weak and absent, respectively. CONCLUSIONS: Despite widespread uptake of RFA and acceptance of its clinical advantages over open surgery there is a paucity of Class 1 A evidence. This results from incongruent reporting of clinical outcome measures within existing literature. Similarly, lack of long-term follow-up studies precludes comparison of the durability of short- and medium-term advantages of RFA with the longer term results of open surgery. There remains scope for a large prospective high-quality trial to assess the clinical, anatomical and cost-effectiveness outcomes for the four commercially available RFA devices, with a particular focus on long-term follow up.