Radiofrequency ablation for uncomplicated varicose veins

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M S Gohel and A H Davies. RFA for uncomplicated varicose veins Original article ablation catheter, the vein is ablated in 7 cm segments with extrinsic compression applied using a roll of crêpe bandage. The manufacturers recommend double treatment of the most proximal venous segment (near the SFJ) and single treatment of subsequent venous segments. Immediately following the ablation, the patency and compressibility of the femoral vein (for GSV ablation) should be verified with ultrasound. (7) Postoperative management, follow-up and outcome surveillance There is no consensus on optimal type or duration of compression following RFA, but TEDS, or class I or II above knee compression stockings worn for one to two weeks are common regimens. Recent guidelines from the American Venous Forum for the reporting of studies of endovenous treatment recommended early (,1 month) and late postoperative duplex scans. Clearly, local resource availability and clinician preference will dictate local follow-up and imaging protocols. It should be noted that the most recent NICE guidance for RFA was published in 2003 and this concluded that the procedure was safe and efficacious, but commented on the lack of long-term studies and recommended audit of outcomes. Results following radiofrequency ablation When interpreting these results, it should be noted that the vast majority of published studies report outcomes using the VNUS Closure TM continuous pull-back catheter, whereas the VNUS ClosureFast TM segmental ablation catheter is the device primarily marketed by VNUS and growing in popularity. A total of 23 published reports, consisting of three randomized trials, two meta-analyses and 15 prospective observational studies were included in this review. Only one prospective case series using the VNUS ClosureFast TM catheter was identified. Details of the studies included are presented in Table 1. Technical success and clinical outcomes Although there is significant heterogeneity between clinical studies and variations in reported outcomes, recanalization of the treated venous segment is commonly reported as a marker of technical success. VNUS closure Reported vein closure rates vary between 67% and 100% (Table 1). In a recent meta-analysis, the early technical success following RFA was found to be 89% (3 months), reducing to 80% after five years. 2 These figures compared favourably to traditional surgery and foam sclerotherapy, but were lower than endovenous laser ablation. By far, the largest patient series treated by VNUS Closure TM was published in 2005 and reported five-year clinical and anatomical outcomes following RFA in 1006 patients (1222 legs). 3 Data were collected from a prospective international registry and occlusion rates of 87.2% were seen at five years. Significant improvements in pain, fatigue and oedema were seen up to five years and interestingly, these improvements were present despite recurrent truncal reflux. Recurrent varicosities were seen in 27% of patients at five years and anatomical failure of RFAwas an independent risk factor for varicosity recurrence. 3 Within randomized studies, recurrent varicosities were seen in 48/217 (22%) of patients at four years. 4 VNUS ClosureFast TM The only published study reporting outcomes following VNUS ClosureFast TM was published in early 2008. The occlusion rate following segmental RFA was 99.6% at two years and 70% of treated patients did not require any analgesia postprocedure. 5 A direct comparison of postoperative pain scores between RFA and laser ablation has been conducted in the Recovery trial sponsored by VNUS (unpublished data), but preliminary results showed significant lower pain scores following VNUS ClosureFast TM . 6 Quality-of-life changes Studies of quality of life are scarce, but significant improvements in disease-specific quality-of-life following RFA were reported in the EVOLVeS study, using the CIVIQ2 questionnaire. 7,8 Moreover, these quality-of-life gains were greater than patients treated with traditional venous surgery. Cost-effectiveness of treatment To date, there have been few studies assessing the cost-effectiveness of RFA for the treatment of varicose veins. In a small randomized study of 28 patients, a basic cost-analysis demonstrated that VNUS Closure was more expensive than conventional surgery in terms of direct costs, but the Phlebology 2009;24 Suppl 1:42–49 45
Original article M S Gohel and A H Davies. RFA for uncomplicated varicose veins Table 1 Published prospective clinical studies of endovenous radiofrequency ablation (RFA) Author Year Study design Luebke and Brunkwall 4 van den Bos et al. 2 Rautio et al. 9 / Perala et al. 12 Lurie et al. 7 / Lurie et al. 8 Hinchliffe et al. 13 Chandler et al. 14 Manfrini et al. 15 Goldman and Amiry 16 Merchant et al. 17 / Merchant and Pichot 3 Sybrandy and Wittens 18 Weiss and Weiss 19 Fassiadis et al. 20 Hingorani et al. 11 Pichot et al. 21 Ogawa et al. 22 Nicolini 23 Kianifard et al. 24 Dunn et al. 25 Zan et al. 26 Proebstle et al. 5 costs to society were significantly lower in view of the rapid return to work in the RFA group. 9 A subsequent decision-tree analysis also suggested that RFA performed in an office setting may be cheaper than traditional surgery. 10 Clearly, the cost of procedures will be heavily influenced by clinician preferences on type of anaesthetic, the use of concomitant ambulatory phlebectomy and whether to perform bilateral procedures in a single sitting, thus saving the cost of an additional RFA catheter. For the treatment of unilateral great saphenous vein reflux, office-based RFA using only tumescent anaesthesia is likely to be cheaper than traditional GSV-stripping under general anaesthesia, and this has been the main component of the NHS business case produced by VNUS to support the use of their catheters. However, further welldesigned studies of cost-effectiveness are urgently needed to guide those having to make decisions about treatment commissioning and rationing. Potential hazards and adverse events As with all endovenous interventions, RFA may be associated with technical difficulties in cannulation, guide wire and catheter advancement. These issues are likely to resolve with increasing experience and familiarity with the equipment and technique. Specific complications including DVT, skin burns, superficial thrombophlebitis, neuralgia and bruising have been reported following RFA, but the RFA sample size (limbs) Follow-up (months) incidence of these problems appears low. In one study, 12/73 limbs (16%) developed DVT within 30 days of RFA, 11 but the incidence of DVT in the majority of studies is ,1%. Of the 1006 patients recorded in the Closure international registry, the reported complications were DVT (0.9%), phlebitis (2.9%) and skin burn (1.2%), although the majority of burns occurred in patients not given tumescence. 3 The influence of the volume of tumescence and post-procedure compression on the incidence of these complications is poorly understood and warrants further investigation. Training implications Occlusion rate (%) Adverse events There is currently no structured pathway for the training of clinicians to perform endovenous ablation procedures. Those planning to perform RFA should ensure familiarity with the energy generator and treatment catheters and be able to demonstrate competence in the use of intra-operative colour duplex ultrasound. Depending on local resources and knowledge, attendance at clinical workshops and courses or clinical mentorship programmes may help to achieve competence. Delivering a radiofrequency ablation varicose vein service DVT Skin burn 2008 Meta-analysis 315 36 81 – – 2008 Meta-analysis n/a 60 80 – – 2002/2005 RCT 15 36 67 0/15 0/15 2003/2005 RCT 65 24 86 0/65 – 2006 RCT 16 1 81 0/16 – 2000 Prospective 120 12 90 0/120 – 2000 Prospective 151 6 96 0/151 – 2002 Prospective 50 24 68 0/50 – 2002/2005 Prospective 1222 60 87 11/1222 15/1222 2002 Prospective 26 12 88 – 1/26 2002 Prospective 140 24 90 0/21 0/21 2003 Prospective 59 12 98 – – 2004 Prospective 73 1 96 12/73 – 2004 Prospective 63 25 90 – – 2005 Prospective 25 1 100 0/25 – 2005 Prospective 330 36 75 0/330 – 2006 Prospective 51 12 100 – – 2006 Prospective 85 6 90 0/85 0/85 2007 Prospective 24 24 96 – – 2008 Prospective 252 6 99.6 0/252 0/252 RCT, randomized clinical trial. Study of segmental RFA using VNUS ClosureFast 46 Phlebology 2009;24 Suppl 1:42–49 The precise format of a RFA varicose vein service will depend heavily on the personal preference of
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Radiofrequency ablation for uncomplicated varicose veins

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