Changing to endovenous treatment for varicose veins: How much more evidence is needed?

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available at www.sciencedirect.com

The Surgeon, Journal of the Royal Colleges of Surgeons of Edinburgh and Ireland www.thesurgeon.net

Review

Changing to endovenous treatment for varicose veins: How much more evidence is needed? Kieran D. McBride* Queen Margaret Hospital, Dunfermline, NHS Fife, Scotland, UK

article info

abstract

Article history:

Surgical ligation and stripping of varicose veins has been the accepted treatment for almost

Received 28 July 2010

a century but within the last decade this has been challenged by endovenous thermal and

Received in revised form

chemical ablation methods. Surgery is not without significant complications including

30 October 2010

paraesthesia and has reflux recurrence rates of up to 54% at five years, even though it has

Accepted 2 November 2010

been shown to provide significant health-related quality of life benefits cost-effectively.

Available online 12 January 2011

Ultrasound-guided foam sclerotherapy, endovenous laser ablation and radiofrequency ablation are all consistently proving to be at least as beneficial as surgery, without the same

Keywords:

complications and with less post-procedure morbidity and more rapid recovery. This

Varicose veins

article presents a review of the latest published evidence and comparative analysis of vein

Venous incompetence

surgery and it’s alternatives. Endovenous treatment under local anaesthesia in a clinic

Vein surgery

room or office-based setting is now being recognized internationally as an acceptable

Endovenous ablation

standard for dedicated venous practice in a cost-effective environment. Although more

Endothermal ablation

long-term comparative trials of these innovative methods compared with surgery are

Endovenous laser ablation

desirable, many centres are now conducting trials testing the latest endovenous device

Radiofrequency ablation

technologies with each other to support the development of contemporary pathways of

Foam sclerotherapy

care. Patients are entitled to a range of treatment strategies, particularly when complex and recurrent venous disease has such unacceptably high surgical complication and recurrence rates compared to endovenous alternatives. There is questionable logic in procrastinating until there is more convincing evidence. Now is the time for vascular surgeons to enhance their ultrasound skills and future-proof their venous practice for the benefits of patients and institutions. ª 2010 Royal College of Surgeons of Edinburgh (Scottish charity number SC005317) and Royal College of Surgeons in Ireland. Published by Elsevier Ltd. All rights reserved.

Introduction Varicose veins affect up to 25% of the adult population in the U.K with an overall age-adjusted prevalence of truncal varices of 32e40%.1 Standard open varicose vein surgery, usually

sapheno-femoral junction (SFJ) ligation, great saphenous vein (GSV) stripping and multiple phlebectomies, has been used to treat uncomplicated varicose veins for nearly a century.2 Within the last decade new alternatives to surgical treatment have been developed which are having a major impact

* The Scottish Vein Centre, 1, Wemyss Place, Edinburgh, EH3 6DH, UK. Tel.: þ1383 623623; fax: þ131 4661142. E-mail address: [email protected]. 1479-666X/$ e see front matter ª 2010 Royal College of Surgeons of Edinburgh (Scottish charity number SC005317) and Royal College of Surgeons in Ireland. Published by Elsevier Ltd. All rights reserved. doi:10.1016/j.surge.2010.11.002

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on management choices.3 These new treatments for saphenous truncal incompetence include ultrasound-guided foam sclerotherapy (UGFS),4 radiofrequency ablation (RFA)5 and endovenous laser ablation (EVLA).6 We now have a substantial amount of published clinical evidence which includes case series and feasibility studies looking at efficacy, complications and clinical outcomes of chemical and endovenous thermal ablation alternatives to surgery. There are a small, but growing, number of randomized clinical trials (RCT’s) comparing these methods with conventional surgery. Recently important initiatives have been published which endeavour to make sense of all of the evidence to date. These include the Venous Intervention (VEIN) project conducted by the Venous Forum of the Royal Society of Medicine,7 who have invited venous experts to review surgical treatment,2 RFA,8 EVLA9 and sclerotherapy10 for uncomplicated varicose veins. Their aim is to “provide the evidence that supports the development of contemporary pathways of care that will encourage equity of access to individuals with venous disease”. Multi-society consensus documents have just been published that provide quality improvement guidelines for the treatment of lower extremity superficial venous insufficiency with endovenous thermal ablation (RFA and EVLA) and with ambulatory phlebectomy.11,12 The National Institute for Health and Clinical Excellence, NICE, have now issued revised guidelines for the use of UGFS in varicose veins.13 A second European consensus meeting on UGFS has been published to promote standardization of techniques and reporting of outcomes internationally.14 A systematic review has helped to put UGFS in perspective,15 and recent critical review has added to the body of evidence of it’s safety and efficacy.16 There are currently four English language systematic reviews in recognized journals that have analysed the evidence for endovenous therapies, including large case series and several RCT’s and other comparative trials with surgery.17e20 This present review aims to summarize this analysis and also examine all of the more recent literature including the latest reviews and RCT’s.21e24 Trends in provision of the available options of care for varicose veins are obviously changing dramatically, but there appear to be major differences in trends between the U.K, the rest of Europe and North America. The impact of rationing on treatments in the UK will be examined25,26 and the approaches to treatment by UK surgeons, as tested by surveys, will be appraised.27e29 The effects of introducing dedicated vein clinics will be presented30,31 and, in particular outpatient32e34 and office-based35e38 approaches will be examined. Recent reports on the implementation of endovenous service to hospital practice will be reviewed.39,40 A critical appraisal of the limited published attempts to analyse costeffectiveness of endovenous treatment and cost comparisons for surgery and alternative therapies will be given.5,41e45

Methods A search of Medline for all English language articles using keywords varicose veins, venous incompetence, vein surgery, endovenous ablation, endothermal ablation, endovenous

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laser ablation, radiofrequency ablation and foam sclerotherapy was performed. The British Journal of Surgery, Phlebology and international vascular, endovascular and interventional radiology journals were manually searched and full text versions of all relevant articles were reviewed and the quoted references in all retrieved texts were further searched for relevance.

Systematic reviews: a summary Traditional surgical methods to treat varicose veins are associated with significant complications,2,46 high recurrence rates and some patient dissatisfaction.47 In a randomized trial of SFJ ligation methods for primary saphenous incompetence, the two year clinical recurrence rate was 33% and Doppler ultrasound (DUS) proven recurrence was up to 22%.48 However, the clinical benefits and cost-effectiveness of surgery are well established.42 Three recent systematic reviews, two with meta-analysis, have attempted to analyse all of the relevant literature comparing surgical outcomes to UGFS, RFA and EVLA,17e19 and another has compared safety and efficacy of EVLA and surgery.20 The largest meta-analysis examined 64 eligible studies, which included over twelve thousand limbs, with DUS findings as outcome.18 Average follow-up was 32 months and estimated pooled success rates at 3 years were highest for EVLA with 94%, followed by RFA (84%), surgery (78%) and foam sclerotherapy (77%). EVLA was significantly superior to all other methods to abolish saphenous incompetence. RFA and UGFS were equally effective as surgery. This analysis has had some criticism, as most studies reviewed had not used survival analysis, so the success rates are probably inflated.16 In a separate meta-analysis, the improved effectiveness of EVLA is confirmed over surgery, with better post-operative outcomes.17 However venous clinical severity scores (VCSS) were equivalent between EVLA and surgery at end of followup. No differences in early and late outcomes concerning symptoms and recurrence were seen between RFA and surgery up to two years later, but improvements in quality of life (QoL) assessment between surgery and RFA, favoured RFA overall.17 Another systematic review compared safety and efficacy of all treatments, new and old, where articles reported comparisons between at least two treatments.19 This review demonstrated better safety records for both EVLA and RFA compared to surgery, although major surgical complications were rare. Surgery consistently caused more post-operative bruising overall, and more post-operative pain than both EVLA and RFA. Paraesthesia was the most common serious adverse event associated with surgery occurring at a median rate of 11.7% (4.1e30.3%) reported among 517 limbs and ten studies. However, a similar median rate of paraesthesia in a review of case series of RFA quotes 13% over six studies.19 The same systematic review has analysed five RCT’s comparing RFA with surgery, where treatment effectiveness was measured using QoL assessments.5,49,50 Some studies show a significant difference in quality scores for up to 50 days favouring RFA, with equalling out of benefits at one and two year follow-up. There is a consistent trend among studies for patients receiving RFA to return to work and normal activities significantly earlier than for surgery. This is further confirmed

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by meta-analysis in another systematic review,17 which also shows no significant difference between RFA and surgical recurrence rates up to two years. One large series quotes RFA reflux recurrence rates at one and two years at 14% and 21% respectively.49 In the same year, a multi-centre registry of over 1000 patients reported reflux-free rates of 88% at one year and 84% at five years, showing enduring efficacy.50 A newly reported RCT of RFA versus surgery has again demonstrated better early outcomes for RFA, but follow-up was short.45 It is of some interest that, although RFA was successful in all 47 patients, complete saphenous vein stripping was unsuccessful in 7 of 41 (17%) surgical patients. There is still a deficit of long-term comparative outcome data for EVLA versus surgery in RCT’s.6,9,11 A recent systematic review of EVLA versus surgery has analysed 59 studies, 7 of which are comparative trials.20 The methodological quality of these 7 studies is varied and therefore meta-analysis was not used. Reported adverse events were significantly lower for EVLA in all 7 studies for post-operative pain, bruising and haematomas. No statistically significant differences in paraesthesia rates were shown between 21 EVLA and 10 surgical case series, with median rates of 3.4% (0e49%) and 8.8% (1.5e48%) respectively. Abolition of reflux in the comparative trials showed no significant difference (range 88e100%) in reflux-free rates at 6 months to one year. One RCT, not included in previous reviews, showed disease specific QoL scores were similarly improved following both surgery and EVLA.22 This study also reported significantly shorter times for return to work and normal activities for EVLA patients. Another of the original 7 RCT’s analysed has now reported their two year follow-up results for 121 patients.24,51 The new data shows no significant difference in clinical or DUS recurrences between groups. They also had similar improvements in VCSS and QoL gained for both treatments.

Longer-term data The method of pooled success rates at 3 years quoted above from one meta-analysis was used to avoid over-interpretation of outcome figures from single small series, although there are a few large series of medium to longer-term EVLA outcomes already published.18 Agus et al52 reported the outcome of 1076 procedures, with mean follow-up of 3 years and a total vein occlusion rate of 97%. A subsequent series of 500 patients from France has reported a consistently well maintained EVLA occlusion rate of 97% at one and 4 years.53 The longest followup with a mean of 6.7 years, has reported a 7% recurrence rate in 126 of 188 limbs treated by EVLA 7 years previously, from a larger series of 3000 limbs.54 Longitudinal studies of the outcomes in varicose vein surgery all report very high long-term DUS-proven recurrence rates. Following successful initial standard surgery, three year DUS recurrence rates of 23% at the SFJ and 52% at the sapheno-popliteal junction (SPJ) were reported by van Rij et al.55 Neovascularization was a common finding and major contributor to recurrence. Allegra et al56 reported a total five year surgical recurrence rate of 36%. The longest DUS followup study was reported by Winterborn et al.46 Their 5 year neovascularization rate was 54% and 11 year rate was 65%.

However, of the 51% who re-attended, 44 patients (86%) remained relatively satisfied with their outcomes. The same authors have more recently reported neovascularization rates following standard and flush SFJ ligation of 22% and 19% respectively in an RCT at 2 years, with no loss to follow-up.48 An interesting comparative prospective cohort study of neovascularization and recurrence at two years following surgery and EVLA showed similar early clinical recurrence rates of 7%, but the postsurgical neovascularization rate of 18% (11/60) was very significantly higher than the EVLA rate of 1% (1/69).57 The same authors have also shown that following EVLA, persistent non-refluxing GSV tributaries at the SFJ did not appear to have an adverse impact on clinical outcome one year after successful GSV ablation and were not associated with recurrence.58 The reliability of follow-up data in general has been brought into question in a recent review in this journal by Al Samaraee et al.21 Their review rightly points out that most long-term endovenous studies have a high proportion of patients lost to follow-up.6,50,51 Two surgical recurrence papers discussed above had non-attendance rates between 31 and 49%.46,56 The landmark paper by Min et al6 lost 121 of 423 (28%) patients to follow-up at two years, but more prolonged studies at 3, 4 and 7 years showed good compliance and seem to have reliable long-term data.52e54 The review article in The Surgeon was published contemporaneously to three of the four systematic reviews discussed above18e20 and therefore did not benefit from the analysis of these articles. There is general agreement however that more long-term comparative evidence within RCT designs is needed between endovenous therapies and surgery, before definitive conclusions on sustained efficacy can be made.3,7e10

Recurrent varicose veins Recurrent varicose veins account for about 20% of venous operations and they carry a risk of significant complications of 40%, when the groin is explored, causing lymphoceles, wound infections and haematomas.59 Following GSV stripping, DUS has shown that the strip-track can re-vascularize in 23% of cases at one year.60 With high recurrence rates between 36% and 54% at 5 years46,56 and with the prospect of difficult groin re-exploration, it would seem to be an attractive and logical alternative to use non-surgical means to treat SFJ and SPJ recurrence. A summary of published articles on treatments for recurrence is presented in Table 1. Hinchliffe et al61 were first to report comparison of RFA and re-do surgery for GSV recanalization in an RCT of 16 patients. Both legs were treated with both methods as a within-patient double-blind study. RFA caused less pain and bruising and was faster to perform. The authors conclude that RFA should be considered the treatment of choice for recurrence, but this is qualified with the need for longer-term follow-up. Three very recent papers show promising outcomes for the use of EVLA to treat recurrence.62e64 The first paper reported complete success for EVLA in 38 patients at 4e6 week follow-up.62 Another was a retrospective comparative study of 216 patients with DUS follow-up to over one year.63 Post-operative recovery was significantly longer for surgical patients and re-recurrence rates were high at 25 weeks for EVLA and surgery, at 19% and

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Table 1 e Summary of treatments for recurrent varicose veins. Authors, year, (ref.) Hinchliffe et al., 200661

Anchala et al., 200962 Van Groenendael et al., 200963 Nwaejike et al., 201064 Kakkos et al., 200666 Creton et al., 200765

Modality

No. of limbs

Surgery

16

RFA EVLA Surgery

16 56 67

EVLA EVLA UGFS alone Peroperative UGFS

149 77 45 129 (100 GSV) (29 SSV)

Complications

Follow-up mean (range)

Infection 1; Numbness 3; Phlebitis 3, oedema 1 Post-op neuralgia 2 Bruising, some Wound infection 8%; Paraesthesia 27% Prolonged recovery & return to work Paraesthesia 13%; skin tightness 31% Pulmonary embolus 1 5 (11%) superficial thrombophlebitis No foam complications 6 haematomas 2 asymptomatic DVT’s

6 weeks and 1 year

2/16

4e6 weeks 13.5 months

3/16 partial occlusion None. All occluded. 25.8%

15 months 18 months (1e38) 3 weeks 40 days

Doppler reflux

11.5% None. All occluded. 6/45 (13%) 9/129 (7%) (6 at perforators)

Abbreviations; RFA ¼ radiofrequency ablation; EVLA ¼ endovenous laser ablation; UGFS ¼ ultrasound guided foam sclaerotherapy; DVT ¼ deep vein thrombosis.

29% respectively. These rates are unexpectedly high, as a previous long-term endovenous study of 3000 limbs included 456 (19.4%) who had recurrence, with a rate of absence of varicose veins at 7 years of 86%.54 The latest report of EVLA for recurrent reflux states that it is technically as easy to perform as primary EVLA.64 This series of 77 limbs had no re-recurrence at 18 months. Foam sclerotherapy (UGFS) has been used in combination with surgical exploration to correct great and small saphenous recurrence, with complete obliteration of saphenous trunks, junctions and varices in 93% of cases.65 The treatment strategy to use UGFS as an alternative to re-do surgery for recurrent varicose veins has yet to be rigorously tested, with only limited comparative data available.15,16 A single case series of UGFS for recurrence reported early vein obliteration rates of 87%, with no deep vein thrombosis and an 8% rate of superficial thrombophlebitis.66 A separate report, with 62 in a series of 220 limbs (28%) had recurrent vein occlusion rates similar to primary vein occlusion rates of 89%.67 This concurs with results from another larger mixed series with 30% of 808 patients treated for recurrent veins and followed to 11 months, with an occlusion rate of 88%, similar to primary disease outcomes.10,68 Myers et al69 confirmed similarity of outcome at three years between primary and recurrent venous disease, but, like the other authors above, found a tendency to higher recurrence in the small saphenous system. A survey of vascular surgeons in the UK showed that 28% offered UGFS (also in combination with surgery) to their National Health Service (NHS) patients.28 Another specific survey on the use of UGFS (with only half of UK vascular surgeons responding) found that only 25% of those who replied used foam.27 The majority of the users recommended it selectively for patients with recurrent varices (71%) and to older patients (62%). A recent randomized study of surgery versus UGFS for patients with healed varicose ulcers, showed similar significant clinical severity score improvements in both groups.23 Coleridge-Smith emphasizes that results from clinical series are far from conclusive.10 There is some RCT evidence to show that foam is superior to liquid sclerotherapy and that UGFS and surgery can obtain the same outcome, within the limits of data so far published.23,70 There is however a definite need for further long-term studies of the efficacy of UGFS, in particular within RCT study designs comparing this

method with RFA and EVLA.10,16,68 The UGFS methods used and the safe volumes delivered, as recommended in the second European consensus meeting on foam sclerotherapy need now to be tested in appropriate trials.14,68 The overall safety record of UGFS has once again been endorsed by NICE for the off-label use of sclerosants as injected foam.13

Small saphenous incompetence The standard treatment for small saphenous vein (SSV) reflux is ligation at or near the SPJ with or without stripping of the SSV under general anaesthetic (GA) and it accounts for about 20% of vein operations.71However recurrence rates as high as 50% at 3 years have been reported.55 Failure to accurately identify the SPJ using DUS is a major reason, but neovascularization also plays a role. A survey of vascular surgeons (71% response) conducted in 2003 found that 89% routinely used DUS preoperatively.71 Interestingly, even then, 10.6% used a combination of multiple phlebectomies and sclerotherapy to deal with the problem. Since 2007 six case series specifically looking at EVLA for SSV reflux have consistently reported impressive results72e77 (Table 2). Early SSV occlusion rates at 3 months are all above 96%. The longest follow-up, in the most recent report, had a one year occlusion rate of 97% in 147 patients, with 30 patients followed to 3 years with no evidence of recurrence.76 This study noted some temporary paraesthesia up to 4 weeks in 40% of patients, but others report an incidence between 1.3% and 2%.72, 74, 75 The earliest paper from Gibson et al72 noted a tail of thrombus protruding into the popliteal vein in 12 of 210 limbs scanned at 1 week follow-up. Nine patients had short term anticoagulation and none developed deep venous extension or pulmonary emboli. No deep vein thrombosis (DVT) was reported in the other five series. The alternative strategy of UGFS alone for SSV reflux has now been studied by Darvall et al78 in 92 limbs followed by DUS to 12 months. Disease-specific health-related QoL scores were measured. Technical success was 91% with only 3 patients requiring a second treatment. Overall QoL significantly improved and only one popliteal thrombus was treated with anticoagulation. It seems to be less common to offer RFA as treatment of choice for SSV reflux from published studies. In one large RFA

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91% No EVLA or other Tx 6 ml/session (2e8 ml)

None 92 J/cm

Phlebectomy 39% 50e90 J/cm

Foam sclerotherapy 30% 70 J/cm

92 Darvall et al., 200978

147 Desmyttere et al., 201076

67

169 Huisman et al., 200975

Janne d’Othee et al., 201077

229 Kontothanassis et al., 200974

EVLA 810 nm EVLA 980 EVLA 810/980 nm U.G.F.S. alone

Phlebectomy 82% 49 J/cm

Sclerotherapy 18% 66 J/cm

EVLA 810 nm EVLA 810/980 nm 68 Theivacumar et al., 200773

Abbreviations: DVT ¼ deep vein thrombosis; PE ¼ pulmonary embolus; UGFS ¼ ultrasound-guided foam sclerotherapy; EVLA ¼ endovenous laser ablation.

8 months (1e30 m)

12 months

97% at 1 year 100% 2&3 yrs 98.5% Up to 3 years

98%

98.7% 16 months (2e39 m)

3 months

97% 6 months

96% 4 months (2e11 m)

series only 4.3% of cases involved the SSV.50 A systematic review demonstrated a paraesthesia rate of 13% within six case series for GSV RFA.19 The rate would probably be even higher if RFA was routinely used on the very superficial SSV which can run close to the common peroneal nerve and the sural nerve.

New device developments

Numbness 3, (1.6%) Clot popliteal extension 12, (5.7%) No DVT or PE Transient numbness 3, (4.4%) Superficial phlebitis 3, (4.4%) Ecchymosis in majority Nerve injury 5, (2.2%) Calf DVT 3, (1.3%) Sural nerve injury 2, (1.3%) Superficial phlebitis 6, (4%) Ecchymosis 60% Transient numbness (2 weeks), 40% Early paraesthesia 2, (3%) Superficial phlebitis 3, (4%) 1 Popliteal deep vein thrombosis Sclerotherapy 57% Perforator ligation 65% Not stated EVLA 980 nm 210 Gibson et al., 200772

Adjunctive Treatment Energy delivered Modality/ wavelength (nm) No. of limbs Authors, year, reference

Table 2 e Summary of endovenous treatments for small saphenous vein incompetence.

Complications

Follow-up mean (range)

Doppler occlusion

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The new VNUS ClosureFast device (VNUS Medical Technologies, San Jose, CA) acts by providing thermal ablation in 7 cm segments, with temperatures of 85e120  C, in a fraction of previous operating times.79 Radiofrequency powered segmental thermal ablation (RSTA) in 252 GSV’s in a multicentre study with 6 month follow-up had 99.6% occlusion and almost no pain profile.79 Already a randomized study of RSTA and EVLA has been reported with equal technical success in both groups, but significantly less immediate pain and ecchymosis with RSTA.80 Longer-term follow-up is quoted by Enzler et al81 in a recent editorial, with 232 limbs followed up for an average of 13.4 months, with a 94% GSV occlusion rate. Another radiofrequency generator with a bi-polar electrode catheter, the CELON RFiTT system (Olympus, Teltow, Germany) is available and has been compared with EVLA in a randomized within-patient double-blind study.85 The authors found significantly better post-procedure pain and bruising for the first two weeks with RFA. All procedures were performed under GA. They had good equivalent occlusion rates of 95% at 10 days, but disappointing rates of 74% and 78% at 9 months, which they felt was probably due to insufficient energy delivery and too rapid pull-back times for both devices.82 Perceived advantages of reduced RFA post-procedural morbidity and shorter patient recovery times over EVLA may disappear with the advent of new generation EVLA devices operating at longer wavelengths up to 1470 nm. This longer wavelength has better laser energy absorption by water in the vein wall tissue rather than existing lower wavelengths with haemoglobin absorption characteristics.83 The first reported study using 1470 nm laser demonstrated good safety and efficacy but quoted a persistent paraesthesia rate at 1 year of 7.6%.83 A subsequent recent comparative study of 1470 nm laser fibres has compared a bare laser fibre with forward emitting laser energy to a radial-tip fibre which emits energy through 360 .84 The latter group required less energy delivery and produced significantly less post-procedural pain and bruising. All veins remained occluded at 3 months and no paraesthesia was reported. An article still in press from Doganci et al85 has compared 980 nm and 1470 nm EVLA with 6 month follow-up. All GSV’s remained occluded, with significantly less pain, paraesthesia and ecchymosis with the longer wavelength. VCSS reductions were better in this same group for the first month post-EVLA. There has been a trend among established RFA operators to move to RSTA devices with no equipment upgrade requirements. Potential endovenous operators may also perceive there is an advantage beginning with RFA devices so as to avoid the need to address laser safety regulations. New UK guidance was issued in 2009 by the Medicines and Healthcare products Regulatory Agency (MHRA), and measures to deal

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with training and safety precautions are relatively straightforward.86 The evolution to new generation EVLA devices, fibres and wavelengths will be incremental as equipment replacement is required. Some may suggest that endovenous thermal ablation may now be the new gold standard for varicose vein treatment,81 but there is now an additional need for RCT’s to compare these newer technologies with each other80,85 as well as with surgery and UGFS. The latest guidelines for endovenous ablation and ambulatory phlebectomy in the form of mutli-disciplinary consensus documents are a welcome encouragement to promote further research and to standardize reported outcomes.11,12

Operating theatre or clinic room? The endovenous ablation techniques can all be used safely on conscious patients with intracompartmental tumescent anaesthesia, without an Esmarch bandage, in an ambulatory setting.8,9,11,17,18,22,49,52 There has been much discussion in the literature about the appropriate environment for treating chronic venous disorders, but it is accepted that a specialized vein clinic will provide optimum conditions for patients and doctors, and also produce a marked increase in workload and efficiency.30,31 New out-patient facilities have been established within radiology32 and surgical departments,33,34 with the advantageous separation of venous practice from other practice. Since 2005 in the United States there has been a marked increase in the number of “office-based” venous practices.35e38 In that year Medicare and Medicaid significantly reduced professional reimbursement for all minimally invasive procedures in hospital operating rooms and increased it for those performed in a physicians office.38 There are now more than 10 million office-based procedures of all types performed annually.35 Some quarter of a million venous procedures were performed in 2005, 50% by surgery. This is predicted to fall to only 13% overall by 2011, even with a 2.5-fold increase in activity to 600,000 cases.87 Currently over 80% of vein treatments in the US are endovenous, with a 2-to-1 EVLA to RFA ratio.38 There are now new regulations requiring office-based surgical practices to obtain and maintain full accredited status with a nationally recognized accrediting agency.35 In the UK and the rest of Europe, there has been a slower move to non-operative alternatives. It is not possible to reliably interpret the Hospital Episode Statistics on-line currently for England, as the coding is not sufficiently procedure specific (www.hesonline.nhs.uk).88 There has been a reduction in overall procedure numbers from 2001 of approximately 60,000 operations to a plateau of 40,000 cases per annum currently. This is in part due to changes in the recommended indications for vein surgery and also due to increased rationing of resources.25,26 In a recent UK survey of vascular surgeons only 68% said that their Primary Care Trusts (PCT’s) funded treatment for symptomatic varicose veins.29 This survey also revealed that surgery was offered as preferred treatment by 83% of respondents to NHS patients and 72% of private patients. In a separate survey on the future of vein treatment, only 38% of respondents offered two or more modalities to NHS patients.28 A large majority of 70% felt that surgery would remain the commonest treatment in five years time.

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Multiple centres in Italy have been performing EVLA under tumescent anaesthesia since 1999, with excellent safety and efficacy.52 Another multi-centre analysis of EVLA in France, performed outside operating theatres, did not reveal any specific complications related to their environment.34 The authors stated that clinic rooms provide a cost-benefit over operating theatres. Previous EVLA case series have experienced some learning curve issues when establishing an outpatient endovenous practice. The Belfast group had an increased primary technical failure rate of 15% for operators during their first three months of practice.89 Later reports on the impact of introducing new EVLA services to hospital practice are interesting. The Aberdeen group describe the initial use of GA during the operator learning period, when they all became skilled at ultrasound techniques of access and tumescence.39 They also provided adjuvant UGFS in 30% cases and now only perform standard surgery on 11% of their patients. A Dutch group implemented EVLA under GA with tumescence and noted a distinct learning curve, decreasing all their operating times to under 30 min by their fifteenth case.40 They also noted an overall increase in practice activity by 31%.

Quality of life and cost-effectiveness A significant QoL benefit has been proven for surgery to uncomplicated varicose veins in an RCT, which also demonstrated that both standard surgery and foam sclerotherapy fall well below cost-effectiveness funding thresholds for NHS treatments.41,42 Disease specific and health-related QoL improvements have been shown to hold true for EVLA22,24 and RFA.45,49 New evidence also proves there is a significant measured health-related QoL improvement for UGFS for at least 12 months.90 Vuylsteke et al43 have compared the costs of EVLA and surgery and conclude that although the variable costs of surgery were lower, the total costs at public expense were less with EVLA because of earlier return to work. They used GA for their EVLA procedures, making this approach more expensive. Comparative costs of RFA and surgery, both with GA, were compared in a recent trial with the same conclusions.45 A multi-centre Dutch study has shown little difference in calculated quality-adjusted life years gained at two years between EVLA and cryostripping.44 There is currently an ongoing multi-centre randomized trial in the UK, the CLASS trial, comparing UGFS, alone or in combination with EVLA and with conventional surgery which is being conducted by Aberdeen University.91 This trial is looking at differences in clinical outcome, health-related QoL and cost-effectiveness of surgery, EVLA and UGFS up to a proposed five year follow-up. The challenge for this trial and any other randomized studies is to recruit sufficient numbers to obtain statistical power. Michaels et al41 had a 26% attrition rate in their RCT of surgery versus conservative treatment. Darwood et al,22 in an RCT of surgery versus EVLA, could only recruit 118 of 274 suitable patients. EVLA was the stated preference in 60% of non-recruits. Rasmussen et al51 had similar problems, only randomizing 10% of suitable patients to EVLA or surgery. They also had a high loss to follow-up but this improved at later update.24 The Closure Study Group reported good RFA success out to five years, but only in

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a fraction of those treated.50 It could be argued either way that patients fail to re-attend due to satisfaction or dissatisfaction.18,19 A recent health-related QoL study of UGFS made no apology for not having a surgical “control group”, as over 90% of patients stated a preference for foam over surgery.90 This “patient power” is regarded as problematic for recruitment by at least one reviewer.21 However, the results of patient questionnaires have been quite enlightening.

from the various treatments available is how to provide patients with all the information on alternatives and their advantages and disadvantages, in order to gain fully informed consent. This is a difficult task when 80% patients state that the opinion of their vascular surgeon would be likely to or definitely influence their treatment decision.94

Summary Patient preference Patients remained dissatisfied 10 years after vein surgery in 34% of one group questioned.47 In a post-operative survey 21% of patients 3 weeks after surgery were still dissatisfied.92 A recent survey of patients recovering from vein surgery showed that advice from their specialist made no difference on time to return to work (14 days) and full activity (21 days).93 Another survey of patient preference showed that 51% of patients were knowledgeable about endovenous ablation and that 80% stated that their vascular surgeon would influence their treatment decision.94 This fact seems to contradict findings from an on-line survey conducted by the same authors on surgeons’ preferences for treatments.95 Patient preference was the most important factor influencing treatment decisions for 71% of surgeons. Admittedly the survey only had a 31% response rate (survey fatigue possibly?), but those who responded provided interesting information. Of the 30% who perform endovenous procedures, 70% are with local anaesthetic, but only 41% are outpatients. These results mirror those from a postal survey published in 2008.28 Nearly half of respondents reported local restrictions by their PCT’s, but there were disproportionate restrictions regarding the use of EVLA and RFA (60% and 79% respectively). These authors and others suggest that the lack of uptake of endovenous procedures may be due to high initial costs of equipment and training, at a time when varicose vein surgery is subject to increasing scrutiny and funding restrictions.95e97 Patient choice now seems to be a political priority and most published practitioners agree that at least one alternative to conventional surgery should be available.8,9,10,94,97 Not all patients may be suitable for all modalities, and selection criteria differ according to DUS and clinical findings and chosen method. One study found that 73% of patients were suitable for at least one non-surgical option.98 Another paper reported that only 60% of patients were suitable for EVLA.88 Increasing operator experience, particularly with ultrasound and guide-wire techniques, and the use of combinations of EVLA or RFA with UGFS should render the vast majority of patients suitable.22,39,81 The contemporary opinion of twothirds of patients is that they would prefer treatment with local anaesthetic and the same proportion felt the number of visits required would have little or no influence on their choice of treatment.94 Recent comparative approaches to EVLA, with or without concomitant treatment have shown that ablation of a longer length of GSV, to mid calf if possible, will reduce the need for subsequent UGFS.99 The use of concomitant ambulatory phlebectomy has also been shown to reduce the need for subsequent UGFS.100 This prolongs the primary procedure, but showed some early QoL benefits. Patients may not want to be left with small scars however. A major issue now arising

Surgical stripping, junction ligation and phlebectomies have been used to treat varicose veins for nearly a century. The complications of surgery are usually minor and self-limiting but post-operative pain and bruising commonly mean weeks of delay to return to normal activities. Paraesthesia is also relatively common and can be prolonged.17 Up to one third of patients may remain dissatisfied in the long-term. Ultrasound-proven recurrence can be unacceptably high, even within three years and long-term studies show neovascularization rates of over 50% at 5 years.46 Surgical reexploration procedures also have complication rates up to 40%, with very high re-recurrence rates, especially at the SPJ.57 In the last decade chemical ablation (foam sclerotherapy) and endovenous thermal ablation procedures have become established as practical and efficacious alternatives to conventional surgery.5e10 Within the last three years in particular there has been an acceleration in the number of publications including meta-analysis and systematic reviews.17e20 It is accepted that longer-term evidence from RCT’s is still deficient, but the rapid acceptance of endovenous treatments globally may have had an influence on designing trials with proper randomization. The evidence presented in this review confirms that endovenous therapies are at least as safe and effective as standard surgery, but in most of the comparative data presented both EVLA and RFA are consistently better regarding minor and major complications, post-procedure pain and bruising and time to return to work and normal activities.17e20 This has now been assessed accurately using health-related quality of life measurements for all modalities and UGFS, EVLA and RFA all score higher than surgery in the short to medium term.5,24,39,51,61,90 Longer-term wellbeing appears to equilibrate at one and two year follow-up. However, reflux recurrence rates in general and neovascularization in particular are significantly less for RFA and EVLA.46,48 The longer-term benefits and occlusion rates of UGFS are slightly less than those achieved with surgery.17,18 Recurrent varicose veins and small saphenous incompetence together can represent up to 40% of operative cases. Both operations still have persistently high failure rates, even with the use of pre-operative ultrasound.57,59,70 Serious nerve damage is always a risk for both groups of patients. Studies now show that EVLA, RFA and UGFS are very safe and effective in dealing with recurrence and both EVLA and UGFS are potentially the treatments of choice for SPJ incompetence.61,62,71e77 Complication rates including DVT are low and sustained occlusion rates are impressive. The routine use of tumescent anaesthesia in a clinic room setting has now become established as a safe and expedient way to treat varicose veins.33e35 This approach is now standard practice in North America.35e38 The introduction of

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dedicated vein clinics and endovenous services to hospital practice has had a significant and positive impact on treatment delivery, with improved outcomes, activity and costeffectiveness.34,39,40 The need for a robust cost-benefit analysis of the office-based treatment model is now overdue. Hopefully studies like the CLASS trial will provide good QoL and cost-benefit analysis, for multiple modalities, over the longer-term.91 Unfortunately this possibly long delay for even more convincing evidence will mean many potential endovenous operators will have retired, while the methodology evolves and patients opt for non-surgical alternatives and decline participation in trials.81,96,97 Surgeons will need to adapt to learn new ultrasound skills including diagnostic assessment and percutaneous access and anaesthesia.34,39,97 Patient preference requires that we, as providers, give them accurate information on all options. NICE and other consensus documents are helping to do this.13,14 However, we also need to convince our healthcare purchasers that the new alternatives to surgery will provide significant health-related QoL benefits in an efficient and cost-effective environment outside the operating theatre. The time has come to embrace this opportunity to advance modern vein practices, where our time and energy can be devoted to developing care pathways that use the latest technologies based on best evidence comparing their respective outcomes, and ultimately comparing these to historical surgical data.

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