Randomized Clinical Trial of Endovenous Laser Ablation

Transcrição

RANDOMIZED CLINICAL TRIAL
Randomized Clinical Trial of Endovenous Laser Ablation Versus
Conventional Surgery for Small Saphenous Varicose Veins
Nehemiah Samuel, MBBS, MRCS, Daniel Carradice, MBChB, MRCS, Tom Wallace, MBBS, MRCS,
Anthony Mekako, MBBS, MRCS, Josie Hatfield, RGN, and Ian Chetter, MD, FRCS
Introduction: No randomized clinical trial comparing treatment options for
small saphenous vein (SSV) incompetence exists, and there is no clear evidence that this axis behaves the same as the great saphenous vein after
treatment. This means that the existing literature base, centered on the treatment of great saphenous vein incompetence cannot simply be extrapolated to
inform the management of SSV insufficiency. This trial compares the gold
standard of conventional surgery and endovenous laser ablation (EVLA) in
the management of SSV incompetence.
Methods: Patients with unilateral, primary saphenopopliteal junction incompetence and SSV reflux were randomized equally into parallel groups receiving
either surgery or EVLA. Patients were assessed at baseline and weeks 1, 6,
12, and 52. Outcomes included successful abolition of axial reflux on duplex,
visual analog pain scores, recovery time, complication rates, Venous Clinical
Severity Score, and quality of life profiling.
Results: A total of 106 patients were recruited and randomized to surgery
(n = 53) or EVLA (n = 53). Abolition of SSV reflux was significantly higher
after EVLA (96.2%) than surgery (71.7%) (P < 0.001). Postoperative pain
was significantly lower after EVLA (P < 0.05), allowing an earlier return
to work and normal function (P < 0.001). Minor sensory disturbance was
significantly lower in the EVLA group (7.5%) than in surgery (26.4%) (P =
0.009). Both groups demonstrated similar improvements in Venous Clinical
Severity Score and quality of life.
Conclusion: EVLA produced the same clinical benefits as conventional
surgery but was more effective in addressing the underlying pathophysiology and was associated with less periprocedural morbidity allowing a faster
recovery. (Registration number: NCT00841178.)
Keywords: endovenous laser ablation, inversion stripping, quality of life,
saphenopopliteal ligation, small saphenous varicose veins
junction (SPJ) incompetence with associated small saphenous vein
(SSV) reflux.3–5 Symptomatic small saphenous axis incompetence
is significant and can result in a greater disease-specific quality of
life (QOL) impairment than incompetence in the GSV axis, when
controlling for clinical disease severity.6 SPJ ligation with or without stripping of SSV is currently the accepted gold standard surgical
treatment of SSV axis incompetence.7 This procedure is generally
considered more challenging than groin dissection due to the varied
SPJ anatomy and the close proximity to sensory and motor nerves. The
risk of complications therefore increases with thorough exploration
of the popliteal fossa whereas limited exploration potentiates the risk
of recurrence.8 This technical dilemma was highlighted in a survey
of the Vascular Surgeons of Great Britain and Ireland wherein there
was lack of consensus on the best surgical technique for SPJ/SSV
incompetence.7 In addition, disappointingly high residual and recurrent varicosities after SPJ ligation provide an impetus for surgeons to
consider alternate treatment modalities.9 Newer minimally invasive
endothermal ablation procedures are being increasingly used for SSV
reflux, with promising results in case series.10–13 Although the advantages of minimally invasive procedures over conventional surgery in
the treatment of the GSV are well established in the context of randomized trial and meta-analyses,14–17 no such evidence exists in the
treatment of the SSV. There is some suggestion that the SSV may behave differently to the GSV after treatment,6 precluding extrapolation
of the current evidence base centered upon GSV management. This
study aimed to generate level 1 evidence in the management of SSV
reflux by comparing the safety, technical efficacy, and clinical effectiveness of conventional surgery and minimally invasive endovenous
laser ablation (EVLA).
(Ann Surg 2013;257: 419–426)
METHODS
L
ower limb varicose veins are a common problem in the United
Kingdom, affecting up to 40% of the adult population.1,2 In the
majority of sufferers, their varicose veins are associated with saphenofemoral junction incompetence and great saphenous vein (GSV)
reflux; however, an estimated 15% have isolated saphenopopliteal
From the Academic Vascular Surgical Unit, Hull York Medical School/University
of Hull, United Kingdom.
Presented to the Annual General Meeting of the Vascular Society of Great Britain
and Ireland, Edinburgh, United Kingdom, November 2011. Winner of the Venous Forum Prize of the Royal Society of Medicine.
Disclosure: The primary funding source for this study was internal University
funding. Diomed/Angiodynamics (Cambridge, United Kingdom) also provided 50% of a research nurse’s salary over a 12-month period to facilitate
our work but had no involvement or influence in the design, data collection/analysis, writing of the report, or in the decision to submit for publication.
Diomed/Angiodynamics does not have access to any unpublished data.
Reprints: Nehemiah Samuel MBBS, MRCS, Academic Surgical Vascular Unit, 1st
Floor, Tower Block, Hull Royal Infirmary, Anlaby Rd, Hull HU3 2JZ. E-mail:
[email protected].
C 2013 by Lippincott Williams & Wilkins
Copyright ISSN: 0003-4932/13/25703-0419
DOI: 10.1097/SLA.0b013e318275f4e4
Annals of Surgery r Volume 257, Number 3, March 2013
This nonblinded single center randomized controlled trial, the
Hull Endovenous Laser Project 2 (HELP-2), was approved by the local
research ethics committee and the institutional research and development departments. Patients presenting to a tertiary referral vascular
surgical department with primary symptomatic varicose veins during October 2005 to January 2010 were assessed for suitability to
participate in this trial.
The inclusion criteria were primary, symptomatic, unilateral
varicose veins, with isolated SPJ incompetence, causing reflux into
the SSV. Incompetence on duplex ultrasound (DUS) was defined as
retrograde flow of ≥1 second on spectral Doppler after augmentation.
The exclusion criteria were reflux in the GSV axis or deep veins on
DUS examination, previous treatment of ipsilateral varicose veins,
deep venous obstruction, younger than 18 years, pregnancy, impalpable foot pulses, and inability to give informed consent or complete
questionnaires during participation in the trial.
Patients were initially seen in a 1-stop varicose veins clinic,
where a detailed clinical assessment and DUS examination was undertaken by the consultant vascular surgeon or a vascular fellow with a
special interest in the management of venous disease. All DUS examinations were performed according to international consensus protocol
by appropriately qualified practitioners with experience in planning
www.annalsofsurgery.com | 419
Copyright © 2013 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
Samuel et al
and performing endovenous procedures18,19 Following informed written consent, eligible patients were randomized using sealed, opaque
envelopes to receive either surgery or EVLA.
The power calculation was based on the presence of persistent
SSV reflux on DUS after surgery (Joint Vascular Research Group
study)20 versus reflux rates post-EVLA (based on unpublished pilot
work). Using the χ 2 test with continuity correction, 48 limbs were
required per group to detect a statistically significant difference in the
proportion of patients with residual reflux at 6 weeks at the 5% level
with 80% power. Allowing for a 10% loss to follow-up, 53 patients
were required in each group.
Interventions
All patients underwent preoperative DUS marking of the SPJ,
SSV, incompetent perforators, and varicose tributaries in the standing
position.
All surgical procedures involved formal exploration of the
popliteal fossa under general anesthesia, predominantly undertaken
as day case procedures. Saphenopopliteal ligation was attempted followed by inversion stripping of the SSV. Where the SSV drained
directly into the popliteal vein (PV), the level of ligation of the SSV
was flush with the PV. If the SSV joined the gastrocnaemius vein
(GV) before the PV, then the level of ligation was at the junction
with the GV. If the SSV extended cranially above the SPJ, then this
was simply ligated. If there was no SPJ present within the popliteal
fossa and the SSV extended cranially terminating in a junction with
the deep vein below the midthigh, then it was ligated at that junction.
The sural nerve, where seen, was protected during SSV dissection; no
other nerves were exposed and retractors were placed with caution.
In those limbs where inversion stripping of SSV was not possible, a
short proximal segment of SSV (<5 cm) was excised under direct
vision.
All EVLA procedures were performed under local tumescent
anesthesia in a dedicated clean procedure room within the outpatient
department. Ultrasound-guided percutaneous cannulation was performed with the patient in the prone, reverse Trendelenburg position.
The site of SSV access was the lowest point of demonstrable reflux
above the ankle. A 5 Fr catheter was introduced into the vein using the Seldinger technique, and its tip was accurately positioned
under ultrasound guidance at the SPJ to achieve flush occlusion
at the same anatomical locations at which the ligations were performed in the open surgery group. The patient was then placed in the
Trendelenburg position, and perivenous tumescent local anesthetic
(20 mL of 2% lidocaine with 1:200,000 adrenaline and 20 mL of
0.5% levobupivicaine in 1 L of 0.9% saline) infiltrated along the axial vein and tributaries. A bare-tipped 600-nm laser fiber was then
introduced via the catheter, and laser energy was delivered using an
810-nm diode laser generator (Diomed/Angiodynamics, Cambridge,
United Kingdom) at 14 W power aiming for an energy delivery of
80 to 100 J/cm.
In both groups, stab incisions were made over varicose tributaries, and the veins were avulsed using a kocher’s mosquito clip or
vein hook. Incompetent perforating veins, when present, were also
concomitantly divided and ligated through a 1.0- to 1.5-cm incision.
Stab incisions were closed with Steri-stripsTM (3M, St Paul, MN)
and cotton wool and Panelast (Lohmann & Rauscher International
GmbH & Co. KG, Rengsdorf, DE) elastic adhesive bandage was
applied from ankle to midthigh. This was left in situ until the first
follow-up at 1 week; it was then changed to a thigh length T.E.D.
stocking (Tyco Healthcare, Gosport, United Kingdom), which patients were advised to wear for a further 5 weeks. Postprocedure, both
groups were given identical written instructions to mobilize immediately; to return to normal activities, as much as they were able, as
soon as they felt comfortable; and to refrain from driving until able to
420 | www.annalsofsurgery.com
safely perform emergency maneuvers. A week’s course of diclofenac
50 mg 3 times a day and paracetamol 1 g 4 times a day was prescribed
to all patients, with no associated contraindication to their use, to be
taken regularly. Patients judged to be at increased risk of deep vein
thrombosis (DVT) (those with a history of DVT or family history
of DVT, women taking oral oestrogens, immobility) were given prophylactic dose of low-molecular-weight heparin—dalteparin at 5000
IU/d for 5 days.
Outcomes
Because of the nature of the interventions, it was not possible
to blind the investigators or patients to the treatment methods. Patients
were assessed at 1, 6, 12, and 52 weeks postprocedure. The primary
outcome measure was early technical success, defined as abolition of
SSV reflux at 6 weeks postprocedure on DUS assessment.
Secondary Outcomes
Safety was assessed by prospective clinical evaluation, augmented by DUS assessment at each point of follow-up.
Postprocedural pain scores were recorded by the patient in a
pain diary, using an unmarked 10-cm visual analog scale (0, no pain;
10, worst imaginable pain) daily for the first week, alongside the
requirement for supplementary analgesia, the time taken to return to
work and normal activity postprocedure. Patient satisfaction with the
cosmetic outcome and with the overall intervention was recorded on
10-cm unmarked visual analog scales (0, completely unsatisfied; 10,
completely satisfied) at 12 and 52 weeks.
Objective assessment of the severity of venous disease was
performed initially using the clinical grade of the Clinical Etiologic
Anatomic Pathophysiologic classification system (from C0, representing no disease, to C6 characterizing active venous ulceration).21,22
The Venous Clinical Severity Score (VCSS) (a continuous scale from
0 representing no clinical evidence of venous disease to a maximum
of 30) was also used as a dynamic assessment to demonstrate changes
in clinical severity over time. The VCSS has been shown to be a valid
and responsive measure of the severity of venous disease.23–25
Disease-specific QOL was assessed using the Aberdeen Varicose Vein Questionnaire, which measures the QOL impairment directly associated with venous disease. This is scored from 0 (no
impact upon QOL) to a theoretical maximum of 100. This popular
instrument has also been shown to be reliable, valid, and responsive to
measure the specific impact of venous disease on patient’s QOL.26–28
Generic QOL was assessed using 2 instruments: 36-Item Short
Form Health Survey UK version 1 (SF-36 V1) was used to produce
a health profile across 8 physical and psychological domains, each
scored from 0 (worst possible) to 100 (best possible). The domain
profiles include physical function, role limitation due to physical
disability (role—physical), bodily pain, general health, vitality, social function, and role limitation due to emotional problems (role—
emotional) and mental health. Second, the EuroQol 5D instrument
(EQ-5D; EuroQol Group, Rotterdam, The Netherlands) was used to
derive a single index valuation, commonly used in the calculation
of quality-adjusted life years in economic evaluation.29,30 Both these
questionnaires have been validated to measure efficacy of venous
treatment.26–28,31–34
Statistical Analysis
Data were recorded onto a dedicated database (Microsoft
Access; Microsoft, Redmond, WA). Continuous data were first tested
for normality. Normally distributed data were presented as mean (SD),
and significance testing was performed with paired and unpaired t
tests. The data that were not normally distributed were presented as
median (interquartile) values and analyzed using the Mann-Whitney
U test for unrelated samples and Wilcoxon signed rank test for paired
C 2013 Lippincott Williams & Wilkins
samples. Friedman test was used to analyze multiple related samples
across the study interval. Categorical data were analyzed using the
χ 2 test or the Fisher exact test when necessary.
RESULTS
A total of 767 patients were assessed for eligibility to participate in the trial. One hundred six patients (106 legs) were randomized
and received treatment as intended (Fig. 1). Baseline demographics were comparable between the 2 groups with the majority being
women, predominantly presenting with uncomplicated C2 venous
disease (Table 1).
Interventions
In the surgery group, the SPJ was identified and flush ligation
was possible in 51 (96.2%) legs; however, inversion stripping of
the SSV was possible only in 35 (66%) legs. In the remaining 18
patients, complete stripping was not possible due to vein snapping,
tortuosity, spasm, or a combination of the above. Because of this, the
median (interquartile) length of SSV stripped was only 10 (3–19) cm
across the 53 patients in comparison with the EVLA group where
EVLA Versus Surgery for SSV Incompetence
the length of SSV ablated was 24.5 (18.3–30.5) cm P < 0.001. In
the EVLA group, successful thermal ablation was achieved in all 53
(100%) patients; the mean (SD) energy density delivered was 99.2
(18.6) J/cm. There was no significant difference in the mean (SD)
procedure duration for surgery and EVLA: 63.6 (16.6) versus 58.5
(14.8) minutes, respectively (P = 0·111). Unsuitability for day-case
general anesthesia necessitated 4 of 53 (7.5%) inpatient treatments in
the surgical group in comparison with 1 of 53 (1.8%) in the EVLA
group who required overnight stay postprocedure (P = 0.362).
Technical Success
The primary outcome of abolition of SSV reflux on DUS at 6
weeks was significantly higher for 51 (96.2%) patients in the EVLA
group than 38 (71.7%) patients in the surgery group (P < 0.001)
(Table 2). The relative risk (95% confidence interval) of early success
with EVLA compared with surgery was 1·34 (1·11–1·44), giving
a risk difference of 0·24 (0·09–0·30). The number needed to treat
(NNT) with EVLA rather than surgery to avoid a residual refluxing
SSV postprocedure was 4.0 (3.2–10.9). Residual reflux in the surgical
group was due to the inability to strip the SSV as previously discussed,
FIGURE 1. CONSORT chart depicting the progress of patients through the trial. SFJ indicates saphenofemoral junction.
Samuel et al
TABLE 1. Demographics and Quality of Life Measures at
Baseline
Surgery
EVLA
P∗
Age (yr)†
47.5 (12.9)
47.8 (12.2)
0.890‡
Women
40 (75.5%)
34 (64.2%)
0.204
BMI†
24.9 (5.3)
25.9 (3.2)
0.376‡
CEAP clinical grade
0.444
C2
46 (86.8%)
40 (75.5%)
C3
1 (1.9%)
2 (3.8%)
C4
4 (7.5%)
9 (17.0%)
C5
2 (3.8%)
2 (3.8%)
VCSS§
3 (2–4)
3 (2–4.5)
0.299||
AVVQ†
14.53 (6.02)
13.22 (5.97)
0.215‡
EQ-5D§
0.877(0.796–1.0) 0.808 (0.726–1.0) 0.249||
SF-36 domain profiles§
Physical Function
90 (70–100)
90 (75–100)
0.891||
Physical Role
100 (50–100)
100 (50–100)
0.969||
Bodily Pain
74 (42–88)
74 (51–84)
0.826||
General Health
77 (52–87)
77 (53.2–84.2) 0.606||
Vitality
65 (50–80)
55 (46.2–75)
0.072||
Social Function
100 (75–100)
100 (75–100)
0.420||
Emotional Role
100
100 (75–100)
0.820||
Mental Health
80 (72–88)
78 (60–87)
0.167||
Values are expressed as percentages unless otherwise specified.
∗ 2
χ test.
†Mean (SD).
‡Student t test.
§Medians (IRQ).
||Mann-Whitney U test.
AVVQ indicates AberdeenVaricose Vein Questionnaire; BMI, body mass index;
CEAP, Clinical Etiologic Anatomic Pathophysiologic; EQ-5D, EuroQol 5D; VCSS,
Venous Clinical Severity Score.
whereas in the EVLA group 3 legs developed partial recanalization
of the treated segments (having received energy densities of 90, 92,
and 99 J/cm, and preprocedural proximal vein diameters of 5.8, 10.7,
and 10.4 mm, respectively) between 3 and 12 months.
Complications and Recurrence
Minor complication rates were relatively low in both groups;
however, sensory disturbance (predominantly in the sural nerve distribution) was significantly higher in the surgical group at 6-week
follow-up—14 (26.4%) patients compared with 4 (7.5%) patients
in the EVLA group, P = 0.009. The majority of these cases,
however, improved spontaneously leaving persistent sensory disturbance in only 5 (9.4%) surgery patients and 2 (3.7%) EVLA patients,
P = 0.434 at 1 year. A single major complication of DVT in the PV
was recorded during the 1 week DUS evaluation postsurgery. This
otherwise asymptomatic patient was treated with 3 months of oral
anticoagulation; the DVT had completely resolved over this time,
leaving a patent and competent deep venous system and no clinical
evidence of PE.
Clinical recurrence (defined as clinically evident varicose veins
at least 3 mm in diameter not present at 1 or 6 weeks but becoming
apparent during subsequent follow-up) over the 1-year follow-up period was low in both surgical and EVLA groups: 9 (16.9%) versus
5 (9.4%) legs, respectively; P = 0.390. Patterns of recurrence are
listed in Table 3. Four symptomatic surgical patients required further
treatment: Three patients were treated with EVLA of the incompetent
residual SSV and concomitant ambulatory phlebectomies; 1 further
patient demonstrated disease progression with neoreflux in the previously competent anterior accessory saphenous vein, which was superficial and tortuous and so, was treated by ambulatory phlebectomy
under local anesthesia. Ten of 18 patients (55.5%) with intact un422 | www.annalsofsurgery.com
stripped SSV did not develop clinical recurrence; however, at the end
of 1-year follow-up, all of these 10 patients continued to have duplex
demonstrable SSV reflux. In the EVLA group, 2 patients developed
asymptomatic SSV recanalization, having received laser energy density of 90 and 92 J/cm, compared with an overall mean of 99 J/cm;
these patients did not want further treatment at this time. Similarly,
another patient who demonstrated disease progression with neoreflux
in both anterior accessory saphenous vein and midcalf perforator remained asymptomatic and did not consider further treatment. One
patient each in the same group developed symptomatic reflux in calf
perforators and posterior thigh perforator, which were all ligated under local anesthesia.
Venous Severity Scores
In both groups, there was significant improvement (lower
scores) in the VCSS scores over the follow-up period, from a baseline
median (IQR) of 3 (2–4) to 0 (0–1) at the end of 12 months (P <
0.001). There was no significant difference between the groups at any
time points.
Quality of Life and Patient Satisfaction
Both treatments produced a similar durable improvement in
disease-specific QOL scores over the study period (P < 0·001)
(Table 4).
Both treatments also demonstrated similar benefits in generic
QOL domains and importantly, this culminated in significant quality
adjusted life year gains with a significant improvement in index utility
scores using the EQ-5D index utility score (P < 0.001) (Table 4).
Patient satisfaction was equally high with either treatment. At
1 year, satisfaction with the overall treatment was a median (IQR) of
9 (8–10) and cosmetic outcome of the treated leg was 8 (7–10) versus
9 (7.2–10) in the surgical and EVLA groups, respectively.
Periprocedural Pain and Return to Normal
Functioning
Between days 4 and 7, pain scores were significantly lower
in the EVLA group than in the surgical group (Day 4, P = 0.025;
Day 5, P = 0.008; Day 6, P = 0.033; Day 7, P = 0.042) (Fig. 2),
despite having no difference in the frequency of analgesia intake.
Consequently, patients returned to work and routine activities more
quickly after EVLA than after surgery (P < 0·001) (Fig. 3).
DISCUSSION
This study clearly demonstrates that both treatments are safe
and effective. They both improve the clinical severity of venous disease as evidenced by the reduction in VCSS scores, thereby resulting
in tangible benefit in both generic- and disease-specific QOL.
This is the first RCT comparing conventional surgery and minimally invasive endovenous techniques for SSV insufficiency. It was
powered to objectively compare the technical outcomes after treatment of SSV incompetence, with the hypothesis that effective abolition of SSV reflux would reduce future recurrence rates.20 EVLA
was clearly found to offer superior early technical success, similar
to results from other noncomparative observational studies.10–13,35–37
With this sample size, recurrence rates were similar at 1 year, but
long-term follow-up will establish the fate of those with residual incompetence after failed stripping and the rates of disease progression
in a population with successfully treated SSV insufficiency. In this
study, the fact that all of the residual, incompetent, unstripped SSVs
failed to revert to competence supports the hypothesis that it is the
elimination of SSV reflux that is important and that ligation of SPJ
alone is insufficient. It is interesting that despite the technical inadequacies of SSV surgery, the clinical recurrence rates were significantly
TABLE 2. Duplex Ultrasound Findings of Small Saphenous Venous System
Surgery
Preoperation
Median (IQR) vein diameter (mm)
Perforators, reflux >1 s
Patent, no or flash reflux
Patent, reflux >1 s
At 1 wk
Ligated/occluded/absent
Patent, reflux >1 s
At 6 wk
Patent, reflux >1 s
At 12 wk
Patent, reflux >1 s
At 52 wk
Patent, reflux >1 s
EVLA
SPJ
Proximal SSV
Mid-SSV
Distal SSV
SPJ
Proximal SSV
Mid-SSV
Distal SSV
53
6.9 (7.6–5.9)
0
0
53
5.3 (4.4–5.9)
1 (MCP)
3
50
3.0 (3.9–2.6)
0
28
25
2
51
6.5 (7.8–5.5)
1 (PT)
0
53
5.0 (6.0–4.1)
2 (MCP)
3
50
3.1 (4.0–2.8)
0
31
22
51
0
1
38
0
14
30
13
9
0
37
15
45
7
0
52
0
0
52
0
0
10
37
5
46
2
4
38
0
14
25
13
14
0
35
17
45
6
0
51
0
0
51
0
0
12
31
8
43
3
5
38
0
13
24
13
14
0
32
19
44
4
2
47
0
3
46
0
4
6
34
10
46
3
2
38
3
10
28
13
10
3
32
16
42
4
2
45
0
3
43
0
5
3
33
12
Values are aggregate number of limbs at the various time points.
IQR indicates interquartile; MCP, midcalf perforator; PT, posterior thigh perforator.
TABLE 3. Postoperative Complications and Clinical Recurrence
Complications
Sensory disturbance at 6 wk
At 52 wk
Phlebitis
Infection (phlebectomy site)
Skin pigmentation
Hematoma
DVT
Clinical recurrence over 52 wk
Surgery
EVLA
P∗
14 (26.4%)
5 (9.4%)
1 (1.9%)
1 (1.9%)
0
2 (3.8%)
1 (1.9%)
9 (16.9%)
Incompetent SSV: 8
Incompetent AASV: 1
4 (7.5%)
2 (3.7%)
3 (5.7%)
0
2 (3.8%)
0
0
5 (9.4%)
Recanalization: 2
Incompetent ALTB + calf perforator: 1
Incompetent posterior thigh perforator: 1
Incompetent calf perforator: 1
0.009
0.434
0.309
0.500
0.248
0.248
0.500
0.390
Values are expressed as percentages.
∗
Fisher exact test.
AASV indicates anterior accessory saphenous vein; ALTB anterolateral thigh branch.
less at 1 year than those observed after successful saphenofemoral
junction ligation and stripping.17 The reason for this is unknown, but
this highlights another difference between the management of these
2 distinct clinical patterns.
Despite concerns regarding sural nerve injury resulting from
SSV stripping,38 this technique has been shown to decrease recurrence
rates after SPJ ligation.20 As this study was powered to compare the
relationship of technical outcomes and recurrence, rather than specifically exploring periprocedural morbidity in depth, SSV stripping
was selected as a necessary component in the surgical treatment arm.
Despite this, the early technical results of EVLA surpass those of
surgery. It is possible that the use of antegrade stripping for those
veins that snapped may address this, but this technique was not used
in this study.
In common with the early RCTs comparing EVLA and conventional surgery for GSV insufficiency,15,39,40 this study was under
powered for detailed QOL analysis and therefore cannot confirm or
refute any true benefit of EVLA over surgery in this area. However,
less pain and a faster recovery after EVLA seem promising and have
been suggested previously by nonrandomized data.10,41 It is possible
that the use of tumescent anesthesia before stripping may improve
postprocedural pain, immobility, and nerve injury, but this was not
used in this study.
Some surgeons are reluctant to use thermal ablation in the
management of SSV insufficiency, despite using it in the treatment
of GSV and many opt for foam sclerotherapy instead. One reason for
this is a perceived difficulty in passing the wire through the SPJ. The
treatment protocol in this study aimed for a flush occlusion of the
SPJ and in the vast majority of cases within and outside of this trial;
a wire can be passed if the junction is a significant source of reflux.
Sometimes, a hydrophilic wire can help with a difficult junction,
in conjunction with a little rotational torque. In cases in which the
Samuel et al
TABLE 4. Quality of Life Measures Over Follow-up
Period
Surgery
AVVQ scores∗
1 wk
6 wk
12 wk
52 wk
SF-36 scores‡
Physical function
1 wk
6 wk
12 wk
52 wk
Role physical
1 wk
6 wk
12 wk
52 wk
Bodily pain
1 wk
6 wk
12 wk
52 wk
General health
1 wk
6 wk
12 wk
52 wk
Vitality
1 wk
6 wk
12 wk
52 wk
Social function
1 wk
6 wk
12 wk
52 wk
Role emotional
1 wk
6 wk
12 wk
52 wk
Mental health
1 wk
6 wk
12 wk
52 wk
EQ-5D score‡
1 wk
6 wk
12 wk
52 wk
17.92 (6.41)
8.77 (5.52)
5.23 (5.28)
5.30 (5.74)
EVLA
16.22 (6.19)
8.78 (7.22)
5.05 (4.87)
4.22 (5.95)
P§
0.092†
0.996†
0.787†
0.327†
70 (50–90)
95 (85–100)
95 (85–100)
95 (85–100)
80 (61.2–95)
95 (75–100)
95 (80–100)
95 (77.5–100)
0.095
0.708
0.766
0.896
50 (0–100)
100 (25–100)
100 (75–100)
100
50 (0–100)
100 (31.2–100)
100 (50–100)
100 (75–100)
0.277
0.644
0.779
0.502
52 (41–74)
74 (54–100)
84 (62–100)
84 (61.7–100)
62 (41–84)
84 (62–100)
84 (62–100)
84 (62–100)
0.325
0.469
0.483
0.280
77 (53.2–92)
82 (67–92)
77 (64.5–91)
82 (67–92.7)
77 (55.5–82)
77 (57–89.2)
74.5 (62–87)
72 (57–86.5)
0.341
0.175
0.403
0.077
60 (45–73.7)
70 (60–85)
70 (50–80)
75 (53.7–85)
62.5 (45–73.7)
68.3 (45–80)
70 (45–80)
65 (50–75)
0.690
0.325
0.774
0.136
75 (50–100)
100 (62.5–100)
100 (75–100)
100 (78.1–100)
87.5 (62.5–100)
100 (75–100)
100 (75–100)
100 (75–100)
0.082
0.198
0.877
0.364
100
100
100
100
100 (66.7–100)
100
100 (66.6–100)
100
0.498
0.582
0.155
0.510
84 (68–91)
84 (76–92)
88 (74–92)
88 (72–92)
0.766(0.691–0.877)
1.0 (0.806–1.0)
1.0 (0.848–1.0)
1.0 (0.807–1.0)
78(65–92)
80 (68–92)
84 (72–92)
80 (68–90)
0.680
0.369
0.456
0.071
0.796 (0.699–1.0
1.0 (0.841–1.0)
0.965 (0.760–1.0)
0.929(0.783–1.0)
0.256
0.802
0.095
0.119
∗
Mean (SD).
†Student t test for intergroup analysis.
‡Medians (interquartile).
§Mann-Whitney U test for intergroup analysis unless otherwise indicated.
AVVQ indicates Aberdeen Varicose Vein Questionnaire; EQ-5D, EuroQol 5D.
true source of reflux is a cranial extension of the SSV or Giacomini
vein, the wire often passes preferentially into this vein from the SSV
rather than into the deep system. In this case, ablation of the refluxing
segment (in some cases as far as the groin) can be performed. Ablating
past the SPJ rather than up to it typically leaves either an occluded
SPJ or a competent junction receiving flow from the GVs. If the GVs
FIGURE 2. Postprocedural pain. Pain after surgery or endovenous laser ablation recorded on a visual analog scale from 0
to 10. Median (line within box), interquartile range (box), and
range of data with 1·5 × IQR below the first quartile and above
the third quartile (error bars).
FIGURE 3. Return to work and normal activities. Patient’s return
to work and full routine activities after surgery or EVLA. Median
(line within box), interquartile range (box), and range of data
with 1·5 × IQR below the first quartile and above the third
quartile (error bars).
are incompetent preprocedure, however, it is worth initially passing
a wire separately through the SPJ and if required a further wire
through the cranial extension or Giacomini vein. A further anxiety
regarding SSV thermoablation rests with the potential for sural nerve
damage; however, it seems, as noted with the GSV, EVLA results in
less damage to the accompanying nerve than stripping. This is due to
the use of tumescent anesthesia during EVLA and the rates of injury
after stripping may be reduced by tumescent use also (although this
is not in common practice). As this study is not powered for QOL
analysis, the morbidity of the increased early neuropathy rate in the
surgical group is unclear.
One of the limitations of this study is that the patients, surgeons, and assessors could not be blinded to the technique used
due to the nature of these interventions. Risk of observer bias was,
however, reduced as much as possible by recording outcomes (both
primary and secondary) with objective, validated instruments, and
standardized protocols employed by assessors with relevant qualifications and experience. The QOL outcomes were also independently
reported by patients, and the use of both disease-specific and generic
instruments provided a valid and reliable strategy to assess patientreported health states after treatment of their venous disease.27,42
Any new treatment of varicose veins requires long-term followup to determine recurrence rates, and hence further follow-up will be
undertaken in this trial. Recanalization has been reported after EVLA
of SSV11,13,35 and may compromise long-term outcomes; a large observational series of 229 SSV EVLAs found a recanalization rate of
1.3% at 2 years,43 whereas prospective data from this RCT indicates
an early rate of 5.6% (3 patients), although it would be inequitable
to compare results between studies using different wavelengths and
energy densities. In this trial, 1 patient developed full-length SSV recanalization due to neoreflux from a previously competent Giacomini
vein whereas the other 2 developed junctional incompetence with reflux into proximal SSV segments, all 3 having been treated above the
810-nm energy density threshold of 60 J/cm.44 These may be related to
the diameter rather than the energy density alone, both of which have
been implicated with increased occurrence of recanalization.11,13,43
In summary, this RCT suggests equivalent improvements in
clinical severity and at least noninferiority of EVLA compared with
conventional surgery in the treatment of SSV incompetence. The
immediate postoperative benefits and short-term technical outcomes
of EVLA would support the future consideration of this procedure as
the standard treatment of small saphenous insufficiency, provided the
long-term results are no worse than following surgery.
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