Radiofrequency ablation for uncomplicated varicose veins

Phlebology 2009;24:42-49
doi:10.1258/phleb.2009.09s005
© 2009 Royal Society of Medicine Press

 

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Original Articles


M S Gohel and
A H Davies 


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

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{at}imperial.ac.uk

Abstract

In recent years, minimally invasive endovenous treatments havegained popularity in the treatment of superficial venous reflux.The perceived advantages of endovenous therapy include reducedpain, high vein occlusion rates, and early return to work andnormal activities. Endovenous radiofrequency ablation (RFA)involves the delivery of thermal energy from a bipolar catheterto the venous segment to be treated. This technique has beenavailable since 1998 and numerous devices and catheters arenow produced. Numerous prospective and randomized studies havecompared the effectiveness of RFA with traditional and endovenousprocedures. In this article, the available evidence for clinicaleffectiveness, quality of life and cost gains following endovenousRFA is summarized. The scientific principles behind RFA andtechnical procedural considerations are discussed and standardsof care for the delivery of endovenous RFA are proposed.

Key Words: varicose veins • great saphenous vein • small saphenous vein • radiofrequency ablation • RFA • treatment • VNUS


Introduction

The desire to reduce the operative risks and morbidity followingvaricose vein treatment has been a powerful driver in the developmentof minimally invasive endovenous techniques for the correctionof superficial venous reflux. Radiofrequency energy is commonlyused for the ablation of aberrant electrical pathways in theheart and neoplastic lesions, particularly in the liver andkidney. Radiofrequency ablation (RFA) for the treatment of superficialvenous reflux has been available since 1998 and is now establishedas a safe and efficacious treatment modality for the ablationof refluxing superficial and perforating veins. According todevice manufacturers, over 300,000 patients have been treatedwith endovenous RFA worldwide.

In recent years, the available technology has evolved markedlyand there are now numerous RFA manufacturers and devices available.Significant advances in the other available venous treatmentmodalities, and the increasing emphasis on quality of life andcost-effectiveness, have added further confusion for patientsand clinicians regarding the optimal strategy for the treatmentof varicose veins. The aim of this article is to summarize theavailable evidence for the clinical and quality-of-life outcomesand cost-effectiveness following RFA for superficial venousreflux. Standards of care for the delivery of endovenous RFAwithin a varicose vein service are proposed.


Methods

A systematic review using Pubmed, Embase and Cinahl databaseswas performed to identify relevant clinical studies up to July2008. The initial search terms ‘RFA’, ‘radiofrequencyobliteration’ and ‘VNUS’ were used in combinationwith ‘varicose veins’, ‘endovenous’or ‘venous’ with appropriate search limits. Prospectivestudies, randomized clinical trials and meta-analyses reportingclinical, quality-of-life outcomes or cost-effectiveness werescrutinized.


Principles of radiofrequency ablation


Scientific principles

The underlying principle of RFA involves the delivery of thermalenergy derived from an electric current to the venous segmentto be treated. This is achieved using a bipolar endovenous catheterwith a typical power of 2–4 W, which is used to generatetemperatures of 85–120°C. As the procedure relieson 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 anaesthesiaand extrinsic compression). There is an in-built feedback mechanism,which evaluates the vein wall impedance and can adjust the energydelivery accordingly to ensure that the fibre temperature remainsconsistent.

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® Medical Technologies Inc. (San José, CA, USA). The VNUS ClosureTM catheter has been available for nearly a decade and requires a continuous pullback technique. This was commonly used with a tight compressive rubber bandage (Esmark®, Hygenic Corp., Akron, OH, USA) to facilitate venous emptying during treatment. In 2006, VNUS launched the ClosureFastTM 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 RFSTM stylet) for the ablation of incompetent perforating veins. All VNUS catheters may be used with the VNUS RFG PlusTM generator (Figure 2).



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Figure 1 Illustration of the segmental ablation technique using the VNUS ClosureFastTM catheter. (Reproduced with permission from VNUS)



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Figure 2 VNUS RFG PlusTM radiofrequency generator with ClosureFastTM segmental ablation catheter. (Reproduced with permission from VNUS)

 

The Olympus Celon RFITTTM (Olympus Medical Systems, Hamburg, Germany) is an alternative RFA system which has been upgraded recently (Figure 3). The system uses the continuous pull-backtechnique and claims to treat venous segments at a pull-backspeed of 1 cm/s, although clinical studies using this new deviceare scarce.



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Figure 3 Olympus RFITTTM RFA generator


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:

  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 ClosureTM catheter, a slow infusion of heparinized saline via the catheter is recommended during pullback. With the VNUS ClosureFastTM segmental 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 ClosureTM continuous pull-back catheter, whereas the VNUS ClosureFastTM 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 ClosureFastTM catheter was identified. Details of the studies included are presented in Table 1.



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Table 1 Published prospective clinical studies of endovenous radiofrequency ablation (RFA)


Technical success and clinical outcomes

Although there is significant heterogeneity between clinicalstudies and variations in reported outcomes, recanalizationof the treated venous segment is commonly reported as a markerof 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 ClosureTM 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 RFA was 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 ClosureFastTM

The only published study reporting outcomes following VNUS ClosureFastTM 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 post-procedure.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 ClosureFastTM.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 treatedwith 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 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 influencedby clinician preferences on type of anaesthetic, the use ofconcomitant ambulatory phlebectomy and whether to perform bilateralprocedures in a single sitting, thus saving the cost of an additionalRFA catheter. For the treatment of unilateral great saphenousvein reflux, office-based RFA using only tumescent anaesthesiais likely to be cheaper than traditional GSV-stripping undergeneral anaesthesia, and this has been the main component ofthe NHS business case produced by VNUS to support the use oftheir catheters. However, further well-designed studies of cost-effectivenessare urgently needed to guide those having to make decisionsabout 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 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 ofthe volume of tumescence and post-procedure compression on theincidence of these complications is poorly understood and warrantsfurther investigation.


Training implications

There is currently no structured pathway for the training ofclinicians to perform endovenous ablation procedures. Thoseplanning to perform RFA should ensure familiarity with the energygenerator and treatment catheters and be able to demonstratecompetence in the use of intra-operative colour duplex ultrasound.Depending on local resources and knowledge, attendance at clinicalworkshops and courses or clinical mentorship programmes mayhelp to achieve competence.


Delivering a radiofrequency ablation varicose vein service

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 addressedwhen planning, starting and delivering a RFA varicose vein service.These include:


Training and assessment of competence

The responsible clinician should ensure appropriate theoreticaland practical training for core team members prior to startinga service. Local vascular scientists may be an excellent resourcefor the acquisition of duplex ultrasound skills and it may beappropriate to perform initial cases with a vascular scientistperforming the imaging. Mentorship arrangements involving experiencedpractitioners and departments with a large throughput of RFAprocedures may be useful strategies to acquire and reinforcenew endovenous skills.


Trust approval and funding

The clinical team may be required to undertake a risk assessmentand produce a business case to justify the introduction of anew technique. Proposals should be discussed with Clinical Governanceand Clinical Safety departments. Device manufacturers usuallyhave considerable experience of this process and may be of assistance.


Multidisciplinary team approach

Vascular surgeons, vascular scientists, theatre and outpatientnursing staff are likely to be key members of the multidisciplinaryteam. They should be consulted and involved at each stage ofthe planning, training and service implementation processes.


Patient selection and consent

The process and risks of RFA should be openly discussed withall patients as well as the level of experience of the clinicalteam. Clinical information leaflets should be produced (usinglocal information guidelines) and given to prospective patients.Patients could be directed to the wealth of online informationavailable on endovenous procedures.


Location of treatment

Treatment may be offered in an operating theatre or in an office-basedor adapted clinic room setting. The treatment of patients outsidethe expensive operating theatre setting may seem appealing,but it is essential to ensure that any area considered for RFAtreatment has adequate space, lighting, access to equipmentand other essential facilities. In particular, the availabilityof an appropriate operating table or bed is essential.


Treatment algorithm

To ensure that the provision of RFA is consistent, treatmentalgorithms for the management of patients with varicose veinsshould be locally agreed and disseminated.


Clinical follow-up, outcome evaluation and audit

Specific follow-up protocols will be dictated by individualclinician preference, but efforts should be made to audit technicaland 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-upis controversial, but should ideally include clinical assessmentand colour duplex imaging to evaluate technical success. Thisis particularly important during the learning phase as an objectiveassessment of quality control. Clearly, this policy will bestrongly influenced by local resource availability and a morepragmatic approach of scanning only symptomatic patients maybe preferred. However, as RFA for the treatment of varicoseveins is a novel technique, objective evaluation of technicalsuccess may be desirable. Reasons for not implementing a policyof routine postoperative duplex imaging include cost and alsothe fact that that main determinant of subsequent therapy islikely to be the presence of symptoms, rather than the presenceof venous reflux.

Clinicians should prospectively collect audit data includingprocedural 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 ClosureFastTM catheter,particularly in terms of postoperative pain and bruising. Althoughmany treatment variables are highly dependent on clinician preference,principles for the safe introduction of a RFA service and standardsof care are proposed in this document. Clinicians performingRFA for the treatment of varicose veins should ensure accurateaudit of interventions and outcomes. Further consensus is neededon the optimal post-procedural treatment regimen and follow-upsurveillance in this patient group.


Conflict of interest

The authors hereby declare no conflict of interests.

 

 

 

 

Accepted January 5, 2009
References

 

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