Radiofrequency ablation for uncomplicated varicose veins

Original article 

Radiofrequency ablation for uncomplicated 

varicose veins 

M S Gohel and A H Davies 

Imperial Vascular Unit, Charing Cross Hospital, London W6 8RF, UK 

Introduction 

Abstract 

In recent years, minimally invasive endovenous treatments have gained popularity in the 

treatment of superficial venous reflux. The perceived advantages of endovenous therapy 

include reduced pain, high vein occlusion rates, and early return to work and normal 

activities. Endovenous radiofrequency ablation (RFA) involves the delivery of thermal energy 

from a bipolar catheter to the venous segment to be treated. This technique has been available 

since 1998 and numerous devices and catheters are now produced. Numerous prospective 

and randomized studies have compared the effectiveness of RFA with traditional and 

endovenous procedures. In this article, the available evidence for clinical effectiveness, quality 

of life and cost gains following endovenous RFA is summarized. The scientific principles 

behind RFA and technical procedural considerations are discussed and standards of care for 

the delivery of endovenous RFA are proposed. 

Keywords: varicose veins; great saphenous vein; small saphenous vein; radiofrequency 

ablation; RFA; treatment; VNUS 

The desire to reduce the operative risks and 

morbidity following varicose vein treatment has 

been a powerful driver in the development of 

minimally invasive endovenous techniques for the 

correction of superficial venous reflux. Radiofrequency 

energy is commonly used for the ablation 

of aberrant electrical pathways in the heart and neoplastic 

lesions, particularly in the liver and kidney. 

Radiofrequency ablation (RFA) for the treatment of 

superficial venous reflux has been available since 

1998 and is now established as a safe and efficacious 

treatment modality for the ablation of refluxing 

superficial and perforating veins. According to 

device manufacturers, over 300,000 patients have 

been treated with endovenous RFA worldwide. 

In recent years, the available technology has 

evolved markedly and there are now numerous 

Correspondence: A H Davies MA DM FRCS, Imperial 

Vascular Unit, Department of Vacular Surgery, Charing Cross 

Hospital, London & Division of SORA, Imperial College, 

London. 

Email: a.h.davies@imperial.ac.uk 

Accepted 5 January 2009 

RFA manufacturers and devices available. Significant 

advances in the other available venous treatment 

modalities, and the increasing emphasis on 

quality of life and cost-effectiveness, have added 

further confusion for patients and clinicians 

regarding the optimal strategy for the treatment of 

varicose veins. The aim of this article is to summarize 

the available evidence for the clinical and 

quality-of-life outcomes and cost-effectiveness following 

RFA for superficial venous reflux. Standards 

of care for the delivery of endovenous RFA within a 

varicose vein service are proposed. 

Methods 

Phlebology 2009;24 Suppl 1:42–49. DOI: 10.1258/phleb.2009.09s005 

A systematic review using Pubmed, Embase and 

Cinahl databases was performed to identify relevant 

clinical studies up to July 2008. The initial search 

terms ‘RFA’, ‘radiofrequency obliteration’ and 

‘VNUS’ were used in combination with ‘varicose 

veins’, ‘endovenous’ or ‘venous’ with appropriate 

search limits. Prospective studies, randomized clinical 

trials and meta-analyses reporting clinical, 

quality-of-life outcomes or cost-effectiveness were 

scrutinized.

M S Gohel and A H Davies. RFA for uncomplicated varicose veins Original article 

Principles of radiofrequency ablation 

Scientific principles 

The underlying principle of RFA involves the delivery 

of thermal energy derived from an electric 

current to the venous segment to be treated. This 

is achieved using a bipolar endovenous catheter 

with a typical power of 2–4 W, which is used to 

generate temperatures of 85–1208C. As the procedure 

relies on direct contact between the RFA 

catheter and the vein wall, it is essential that the 

vein is emptied of blood during ablation (achieved 

using Trendelenberg position, use of tumescent 

anaesthesia and extrinsic compression). There is 

an in-built feedback mechanism, which evaluates 

the vein wall impedance and can adjust the 

energy delivery accordingly to ensure that the 

fibre temperature remains consistent. 

Ex vivo histological studies of venous segments 

treated with RFA demonstrated homogeneous 

intimal and medial thermal ablation and disintegration. 

This differed from veins treated with 

endovenous laser ablation, where major perivenous 

tissue ablation and vein wall perforations were 

present. 1 

Available devices 

The current market leader for endovenous RFA 

devices is VNUS w Medical Technologies Inc. (San 

José, CA, USA). The VNUS Closure TM catheter has 

been available for nearly a decade and requires a 

continuous pullback technique. This was com- 

monly used with a tight compressive rubber 

bandage (Esmark w , Hygenic Corp., Akron, OH, 

USA) to facilitate venous emptying during treatment. 

In 2006, VNUS launched the ClosureFast TM 

segmental ablation catheter, which allows RFA of 

superficial veins in 7 cm segments, thus eliminating 

the continuous pull-back technique (Figure 1). The 

segmental ablation has the theoretical advantages 

of greater consistency in the vein treatment and 

increased speed of ablation as each 7 cm segment 

can be treated in 20 seconds. It should be noted 

that VNUS also market a specific stylet device 

(VNUS RFS TM stylet) for the ablation of incompetent 

perforating veins. All VNUS catheters may be 

used with the VNUS RFG Plus TM generator 

(Figure 2). 

The Olympus Celon RFITT TM (Olympus Medical 

Systems, Hamburg, Germany) is an alternative 

RFA system which has been upgraded recently 

(Figure 3). The system uses the continuous pullback 

technique and claims to treat venous segments 

at a pull-back speed of 1 cm/s, although clinical 

studies using this new device are scarce. 

Description of technique 

Although there are broad similarities between the 

various endovenous therapies, the location of treatment, 

type of anaesthetic and numerous other 

factors will be dictated by the personal preference of 

clinicians (see Delivering a radiofrequency ablation 

varicose vein service below). The generic technique 

for RFA can be summarized in the following steps: 

Figure 1 Illustration of the segmental ablation technique using the VNUS ClosureFast TM catheter. 

(Reproduced with permission from VNUS) 

Phlebology 2009;24 Suppl 1:42–49 43

Original article M S Gohel and A H Davies. RFA for uncomplicated varicose veins 

(1) Preoperative planning and consent 

As occlusion of the treated venous segment is 

widely accepted as a measure of treatment 

success, preoperative duplex imaging should 

be performed prior to any endovenous intervention. 

Preoperative marking of the incompetent 

venous segment and junction with the 

deep vein should also be considered, as this 

may aid intra-operative catheter placement. 

Patients should be warned about the potential 

risks of recurrence, nerve damage, skin burns, 

deep venous thermal injury and deep vein 

thrombosis (DVT) (see Adverse events and 

potential hazards below). 

(2) Patient positioning 

The patient should be positioned supine for 

great saphenous or anterior thigh vein ablation 

and in the prone position for ablation of small 

saphenous or Giacomini veins. The operating 

table or trolley should allow Trendelenberg 

and reverse Trendelenberg positioning. 

(3) Cannulation of vein to be treated 

In the reverse Trendelenberg position, the 

refluxing superficial vein should be cannulated 

with a 7F sheath using the Seldinger technique 

under ultrasound guidance. Ideally, the 

cannulation site should be at the most distal 

point of venous reflux and cannulation may 

be facilitated using proximal venous compression 

(to promote venous distension) or 

surgical cut down. 

(4) Positioning of radiofrequency catheter using 

ultrasound 

For the treatment of GSV or SSV reflux, device 

manufacturers recommend that the catheter 

tip should be placed no closer than 2 cm 

from the saphenofemoral or saphenopopliteal 

junctions, respectively. 

(5) Tumescent anaesthesia 

The aim of tumescent anaesthesia is to provide 

a thermal buffer around the vein to be treated 

and also offer perioperative analgesia. A 

dilute mixture of lidocaine in normal saline 

may be used. Fifty millilitres of 1% lidocaine 

with 1:200,000 adrenaline is used in 500 mL 

0.9% saline for unilateral procedures, or in 

1000 mL 0.9% saline for bilateral procedures. 

The same preparations are used for procedures 

performed using local or general anaesthesia. 

The anaesthetic should be delivered under 

ultrasound guidance either by hand using a 

needle and syringe, or using a pump device. 

Volumes of tumescence administered may 

vary, but are commonly in the region of 75– 

100 mL per 10 cm of vein. Care should be 

taken to ensure adequate tumescent infiltration 

between the proximal GSV and deep vein near 

the saphenofemoral junction. With procedures 

performed using tumescent/local anaesthesia 

alone, the use of local anaesthetic cream 

along the length of the vein to be treated may 

aid the administration of tumescence. 

(6) Radiofrequency ablation 

For continuous pull-back systems, the catheter 

should be gradually withdrawn according to 

the recommendations of the specific catheter 

manufacturer. Using the VNUS Closure TM 

catheter, a slow infusion of heparinized saline 

via the catheter is recommended during pullback. 

With the VNUS ClosureFast TM segmental 

Figure 2 VNUS RFG Plus TM radiofrequency generator with 

ClosureFast TM segmental ablation catheter. (Reproduced with 

permission from VNUS) Figure 3 Olympus RFITT TM RFA generator 

44 Phlebology 2009;24 Suppl 1:42–49


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 



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


clinicians. Specific factors dependent on clinician 

preference include: 

† Type of anaesthetic; 

† Treatment strategy for varicosities; 

† Approach to patients requiring bilateral interventions; 

† Postprocedure compression type and duration; 

† Follow-up and surveillance protocol. 

Nevertheless, a number of general key issues 

should be considered and addressed when planning, 

starting and delivering a RFA varicose vein 

service. These include: 

Training and assessment of competence 

The responsible clinician should ensure appropriate 

theoretical and practical training for core team 

members prior to starting a service. Local vascular 

scientists may be an excellent resource for the acquisition 

of duplex ultrasound skills and it may be 

appropriate to perform initial cases with a vascular 

scientist performing the imaging. Mentorship 

arrangements involving experienced practitioners 

and departments with a large throughput of RFA 

procedures may be useful strategies to acquire 

and reinforce new endovenous skills. 

Trust approval and funding 

The clinical team may be required to undertake a 

risk assessment and produce a business case to 

justify the introduction of a new technique. Proposals 

should be discussed with Clinical Governance 

and Clinical Safety departments. Device manufacturers 

usually have considerable experience of this 

process and may be of assistance. 

Multidisciplinary team approach 

Vascular surgeons, vascular scientists, theatre and 

outpatient nursing staff are likely to be key 

members of the multidisciplinary team. They 

should be consulted and involved at each stage of 

the planning, training and service implementation 

processes. 

Patient selection and consent 

The process and risks of RFA should be openly discussed 

with all patients as well as the level of 

experience of the clinical team. Clinical information 

leaflets should be produced (using local information 

guidelines) and given to prospective patients. 

Patients could be directed to the wealth of 

online information available on endovenous 

procedures. 

Location of treatment 

Treatment may be offered in an operating theatre or 

in an office-based or adapted clinic room setting. 

The treatment of patients outside the expensive 

operating theatre setting may seem appealing, but 

it is essential to ensure that any area considered 

for RFA treatment has adequate space, lighting, 

access to equipment and other essential facilities. 

In particular, the availability of an appropriate operating 

table or bed is essential. 

Treatment algorithm 

To ensure that the provision of RFA is consistent, 

treatment algorithms for the management of 

patients with varicose veins should be locally 

agreed and disseminated. 

Clinical follow-up, outcome evaluation and audit 

Specific follow-up protocols will be dictated by 

individual clinician preference, but efforts should 

be made to audit technical and clinical outcomes 

as with all new interventions. 

Proposed standards for endovenous 

radiofrequency ablation 

There are currently no clinical guidelines specifying 

basic standards in the provision of RFA for superficial 

venous reflux. In addition to the principles 

of Clinical Governance, the following benchmarks 

are proposed as minimum standards of clinical 

practice: 

† Intra-operative colour duplex imaging should 

be performed by an individual able to demonstrate 

technical competence in vascular duplex 

imaging; 

† Pre-operative duplex imaging should be performed 

by an accredited vascular scientist (or 

appropriately trained clinician) in all cases; 

† Procedural documentation should include: 

† Length of vein ablated; 

† The vein treated and precise site of cannulation; 

† Duration of treatment; 



† Details of energy delivered, power settings 

and other variables. 

Post-procedural follow-up is controversial, but 

should ideally include clinical assessment and 

colour duplex imaging to evaluate technical success. 

This is particularly important during the learning 

phase as an objective assessment of quality control. 

Clearly, this policy will be strongly influenced by 

local resource availability and a more pragmatic 

approach of scanning only symptomatic patients 

may be preferred. However, as RFA for the treatment 

of varicose veins is a novel technique, objective evaluation 

of technical success may be desirable. Reasons 

for not implementing a policy of routine postoperative 

duplex imaging include cost and also the fact 

that that main determinant of subsequent therapy is 

likely to be the presence of symptoms, rather than 

the presence of venous reflux. 

Clinicians should prospectively collect audit data 

including procedural details, adverse events, clinical 

and technical outcomes. This may be best 

achieved by using an international registry. 

Conclusion 

RFA is established as an acceptable and efficacious 

endovenous treatment modality for the treatment of 

varicose veins. However, further studies are needed 

to clarify the advantages of the recently introduced 

segmental ablation VNUS ClosureFast TM catheter, 

particularly in terms of postoperative pain and bruising. 

Although many treatment variables are highly 

dependent on clinician preference, principles for the 

safe introduction of a RFA service and standards of 

care are proposed in this document. Clinicians performing 

RFA for the treatment of varicose veins 

should ensure accurate audit of interventions and 

outcomes. Further consensus is needed on the 

optimal post-procedural treatment regimen and 

follow-up surveillance in this patient group. 

Conflict of interest 

The authors hereby declare no conflict of interests. 

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Radiofrequency ablation for uncomplicated varicose veins

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