Changing to Endovenous Treatment for Varicose Veins:
How much more evidence is needed?
Dr. Kieran D McBride
Consultant Interventional Radiologist
Victoria Hospital, Kirkcaldy
NHS Fife, Scotland
Address for correspondence:
The Scottish Vein Centre,
1, Wemyss Place,
Edinburgh,
EH3 6DH
Telephone : 0131 4774775
Fax number: 0131 4661142
e-mail: kdmcbride@scottishveincentre.co.uk
Financial support : none
Type of article : Review article
Keywords: Varicose veins; venous incompetence; vein surgery; endovenous
ablation; endothermal ablation; endovenous laser ablation; radiofrequency ablation;
foam sclerotherapy
Short title: Changing to endovenous treatment for varicose veins
The Surgeon, Journal of the Royal Colleges of Edinburgh and Ireland
2011 June vol 9 ( 3 ): 150 - 159
Permission to reproduce article given by Elsevier© 2012
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ABSTRACT
Surgical ligation and stripping of varicose veins has been the accepted treatment for
almost a century but within the last decade this has been challenged by endovenous
thermal and chemical ablation methods. Surgery is not without significant
complications including paraesthesia and has reflux recurrence rates of up to 54% at
five years, even though it has been shown to provide significant health-related
quality of life benefits cost-effectively. 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 complications and with less
post-procedure morbidity and more rapid recovery. This article presents a review of
the latest published evidence and comparative analysis of vein surgery and it’s
alternatives. Endovenous treatment under local anaesthesia in a clinic room or
office-based setting is now being recognized internationally as an acceptable
standard for dedicated venous practice in a cost-effective environment. Although
more long-term comparative trials of these innovative methods compared with
surgery are desirable, many centres are now conducting trials testing the latest
endovenous device technologies with each other to support the development of
contemporary pathways of 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.
TEXT
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 32 – 40% (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 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 IN tervention ( 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 ), EVLA ( 9 )
and sclerotherapy ( 10 ) for uncomplicated varicose veins. Their aim is to “provide
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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 recognised
journals that have analysed the evidence for endovenous therapies, including large
case series and several RCT’s and other comparative trials with surgery ( 17 – 20 ).
This present review aims to summarize this analysis and also examine all of the
more recent literature including the latest reviews and RCT’s ( 21 -24 ).
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 examined ( 25, 26 ) and the approaches to treatment by
UK surgeons , as tested by surveys, will be appraised ( 27 – 29 ). The effects of
introducing dedicated vein clinics will be presented ( 30, 31 ) and , in particular outpatient ( 32 – 34 ) and office-based ( 35 - 38 ) 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
cost-effectiveness of endovenous treatment and cost comparisons for surgery and
alternative therapies will be given ( 5, 41 – 45 ).
Methods
A search of Medline for all English language articles using keywords varicose veins,
venous incompetence, vein surgery, endovenous ablation, endothermal ablation,
endovenous 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 ( 17 – 19 ), 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
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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 follow-up. 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% ( 4.1 – 30.3% ) 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 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 multicentre 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 postoperative 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% ( 0 – 49% ) and 8.8% ( 1.5 – 48% ) respectively. Abolition of
reflux in the comparative trials showed no significant difference ( range 88 - 100% )
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 (
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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 metaanalysis 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 al ( 52 ) 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
follow-up 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 al ( 56 ) reported a total five year surgical recurrence rate of 36%. The
longest DUS follow-up 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 nonattendance rates between 31 and 49% ( 46, 56 ). The landmark paper by Min et al (
6 ) 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 longterm data ( 52 – 54 ). The review article in The Surgeon was published
contemporaneously to three of the four systematic reviews discussed above ( 18 –
20 ) 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, 7 – 10 ).
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
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lymphocoeles, 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 years ( 46, 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 al ( 61 ) 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 ( 62 – 64 ). The first paper reported complete success for EVLA
in 38 patients at 4 to 6 week follow-up ( 62 ). Another was a retrospective
comparative study of 216 patients with DUS follow-up to over one year ( 63 ). Postoperative recovery was significantly longer for surgical patients and re-recurrence
rates were high at 25 weeks for EVLA and surgery, at 19% and 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 al ( 69 ) 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
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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 ( 71 ).However 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 results ( 72 – 77 ) ( 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 2.2 % ( 72
, 74, 75 ). The earliest paper from Gibson et al ( 72 ) 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 al ( 78 ) 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 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
peronael nerve and the sural nerve.
New device developments
The new VNUS ClosureFast device ( VNUS Medical Technologies, San Jose, CA)
acts by providing thermal ablation in 7cm segments, with temperatures of 85 - 120̊C,
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 al ( 81 ) 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
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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 1470nm. 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 1470nm 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 1470nm laser fibres has compared a bare laser fibre
with forward emitting laser energy to a radial-tip fibre which emits energy through
360 degrees ( 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 al
( 85 ) has compared 980nm and 1470nm 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 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 other ( 80, 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 radiology ( 32 ) 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 ( 35 – 38 ). 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 office8
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, Kabnick LS , personal communication ). 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 nonoperative 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.
Multiple centres in Italy have been performing EVLA under tumescent
anaesthesia since 1999, with excellent safety and efficacy ( 52 ). Another multicentre 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 out-patient 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 minutes 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 EVLA ( 22, 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 al ( 43 ) 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
9
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 multicentre 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 costeffectiveness 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 al ( 41 ) 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 al ( 51 ) 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 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.
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 ( 95 – 97 ).
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
10
option ( 98 ). Another paper reported that only 60% of patients were suitable for
EVLA ( 88 ). Increasing operator experience, particularly with ultrasound and guidewire 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 two-thirds 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 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
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 longterm. 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 re-exploration 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 ( 5 – 10 ). Within the last three years in particular
there has been an acceleration in the number of publications including meta-analysis
and systematic reviews ( 17 – 20 ). 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 ( 17 -20 ). This has now been assessed accurately using healthrelated 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
11
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, 71 – 77 ). 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 ( 33 – 35 ).
This approach is now standard practice in North America ( 35 – 38 ). The
introduction of dedicated vein clinics and endovenous services to hospital practice
has had a significant and positive impact on treatment delivery, with improved
outcomes, activity and cost-effectiveness ( 34, 39, 40 ). The need for a robust costbenefit 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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