Veins Eur J Vasc Endovasc Surg (2020) 60, 108e117

RANDOMISED CLINICAL TRIAL

Editor’s Choice – Role of Compression After Radiofrequency Ablation of

Varicose Veins: A Randomised Controlled Trial5
a,b,*
Madu Onwudike , Kazim Abbas a, Paula Thompson b, Damien M. McElvenny c

a
Vascular Surgery, Manchester University NHS Foundation Trust, Manchester, UK
b
Vascular Surgery, Bolton Hospitals NHS Foundation Trust, Bolton, UK
c
Division of Population Health, Health Services Research & Primary Care, University of Manchester, UK

WHAT THIS PAPER ADDS

This study examined the effect of post-procedure leg compression in a full range of patients with superficial
truncal incompetence treated exclusively with radiofrequency ablation (RFA). There was no significant difference
in the target vein occlusion rate, quality of life, venous clinical severity score, patient satisfaction, and pain score
with or without compression. This study provides further evidence that varicose vein patients undergoing RFA
may not require post-procedure compression.

Objective: Post-procedure limb compression, hitherto routine following open varicose vein surgery, has been
extended to endovenous procedures. However, no robust evidence exists to support this practice. Most of the
previous studies have focused on the ideal duration of compression. This study evaluates the clinical and patient
reported outcomes with and without post-procedure leg compression following radiofrequency ablation (RFA).
Methods: This single centre, prospective, non-inferiority randomised controlled trial recruited adult patients, into
two groups (A: RFA with compression stocking for two weeks, B: RFA alone). The primary outcome was
ultrasound determined target vein obliteration at 12 weeks. Secondary outcome measures included a Quality
of Life (QoL) score [Aberdeen Varicose Vein Severity Score (AVSS) and Revised Venous Clinical Severity Score
(RVCSS)], patient satisfaction, pain score, and complications.
Results: In total, 100 consecutive patients were recruited (A: 51; B: 49) classified as clinical class C2eC6 of the Clinical-
Etiological-Anatomical-Pathophysiological (CEAP) classification. At 12 weeks the occlusion rate of the target vein was
similar in both groups at 98% (n ¼ 47) and 98% (n ¼ 45), respectively (p ¼ 1.0). There was no statistically significant
difference in mean AVSS 6 vs. 5.0 (mean difference 1, 95% CI 2 e 3, p ¼ .57) and mean RVCSS 3 vs. 4 (mean
difference 1, 95% CI 1 e 2, p ¼ .46) scores at 12 weeks. Comparable patient satisfaction scores were observed
(p ¼ .72) and pain score 2.0 vs. 2.0 (p ¼ .92) were achieved in both groups. Two patients in each group
developed deep vein thrombosis at two weeks follow up (p ¼ 1.0 for above the knee and p ¼ 1.0 for below the knee).
Conclusion: The clinical and patient reported outcomes following RFA without compression are no worse than
with compression. This trial supports the conclusion that the widely practised use of compression after RFA adds
no clinical benefit for the patients. However, a much larger study, preferably a multicentre trial, may be required
to confirm this conclusion.

Keywords: Compression, Endothermal ablation, Radiofrequency ablation, Varicose veins

Article history: Received 21 July 2019, Accepted 9 March 2020, Available online 8 April 2020
Crown Copyright Ó 2020 Published by Elsevier B.V. on behalf of European Society for Vascular Surgery. All rights reserved.

INTRODUCTION With the advent of minimally invasive techniques, endo-

Varicose veins are relatively common, with a reported
prevalence ranging between 10% and 30% worldwide.1,2
5
This study was presented at the European Venous Forum, Zurich, June
2019.
* Corresponding author. Consultant Vascular Surgeon, Manchester Univer-
sity NHS Foundation Trust, Oxford Road, Manchester, M13 9WL, UK.
E-mail addresses: madu@doctors.org.uk; madu.onwudike@boltonft.nhs.uk
(Madu Onwudike).
1078-5884/Crown Copyright Ó 2020 Published by Elsevier B.V. on behalf of
European Society for Vascular Surgery. All rights reserved.
https://doi.org/10.1016/j.ejvs.2020.03.014
venous techniques including radiofrequency ablation (RFA),
endovenous laser therapy, and foam sclerotherapy have
become the preferred treatment options.3
The use of post-procedure limb compression, following
endovenous treatment of varicose veins has been widely
practised to reduce procedure related side effects including
venous thrombosis, pain, extensive bruising,4 haematoma,
oedema,5 inflammation, or thrombophlebitis.6 There is,
however, limited high level evidence to support this prac-
tice.7 The main drawback of limb compression is patient
RCT on Compression Therapy after Radiofrequency Ablation of Varicose Veins
compliance as a result of discomfort associated with limb
compression, and movement restriction. A meta-analysis
failed to demonstrate significant difference in outcome or
complications between patients who had compression for
four to six weeks compared with those who had compres-
sion for only seven to ten days following open varicose vein
surgery of ligation, stripping, and avulsions.8 There is no
consensus either on the duration of compression therapy
following endovenous therapy. A recent survey of members
of the Society of Vascular Surgeons of Great Britain and
Ireland (141 surgeons, 68 vascular units) reported a signif-
icant variability in duration (mean 10 days, range 2e42
days) in post-operative compression regime following
endovenous therapy for varicose veins.9
The beneficial effect of compression therapy following
endovenous therapy is also variable. A randomised
controlled trial (RCT) of the duration of compression ther-
apy after varicose vein surgery concluded that there was no
significant difference in complications and patient satisfac-
tion in the group that received compression for a shorter
period (one vs. three weeks).10 Similarly, an RCT investi-
gated the need for limb compression following foam
sclerotherapy of truncal lower limb veins and found no
significant difference between compression and no
compression in terms of side effects, patient satisfaction,
and the rates of successful obliteration of the target
vessel.11
The benefits of compression therapy following endove-
nous treatment have recently been questioned. Krasznai
and colleagues12 reported no significant difference in post-
operative pain or recovery time in patients who received
compression for 4 h compared with those who had
compression for 72 h following RFA. A prospective non-
randomised study did not find additional benefit for vein
occlusion rate, superficial thrombophlebitis, and deep vein
thrombosis in prescribing compression therapy following
endovenous laser ablation.13 Ayo et al. compared seven
days compression vs. no compression and reported no dif-
ference in clinical (vein obliteration) and patient reported
outcomes (pain, ecchymosis, and quality of life) following
endovenous ablation.14 In their study of 71 patients and 85
limbs, 91% of patients were treated with RFA. The rest had
endovenous laser therapy (EVLT). While these studies raise
doubts about the necessity for post-procedure compres-
sion, the present study is the first to investigate the role of
post-procedure compression where all the veins were
exclusively ablated using RFA.
The aim of this study was to comparatively investigate
efficacy, complications, and patient satisfaction following
RFA of superficial truncal incompetence, with and without
post-procedure limb compression.
METHODS
Study design
This was a single centre, prospective, non-inferiority RCT.
The study included 100 consecutive patients classified as
109
C2eC6 according to the Clinical-Etiological-Anatomical-
Pathophysiological (CEAP) classification. The C6 patients
included had small ulcers <2 cm in diameter with little or
no exudate and were not already in compression. A duplex
ultrasound scan (DUS) was used for pre-operative assess-
ment of varicose veins. With the patient in a standing po-
sition, reflux was diagnosed when there was at least 0.5 s of
flow reversal in the segment of vein being examined.15
Following informed consent, patients with suitable vari-
cose veins, opting for RFA treatment were recruited to the
study between April 2015 and November 2017. Target veins
that were very tortuous or superficial to the saphenous
fascia and very close to the skin (with attendant higher risk
of thermal skin injury) were deemed unsuitable.
Inclusion criteria for patients were age >18 years, having
superficial truncal incompetence of the great and small
saphenous veins, consent for RFA, suitable for day case
surgery, and CEAP (C2eC6).
Exclusion criteria for patients were age <18 years, BMI
>40, refused consent, not suitable for RFA, secondary
varicose veins, previous deep venous thrombosis (DVT),
active ulceration already on compression, pregnancy, Lycra
allergy, ankle brachial pressure index (ABPI) < 0.9.
Ethical approval was granted by Regional NHS National
Research Ethics Service with Reference Number 15/NW/
0179. The study was registered with International Standard
Randomised Controlled Trial Number (ISRCTN) 18119345.
Study end points
The primary outcome was successful target vein oblitera-
tion as determined by duplex ultrasound scan (DUS) at 10e
12 weeks. The target vein was deemed occluded if no more
than 2 cm of the stump between the treated vein and the
deep vein junction was patent and at least 90% of treated
length had been obliterated. Secondary outcome measures
included changes in quality of life (QoL), disease severity,
patient satisfaction and complications. QoL and disease
severity were assessed using the Aberdeen Varicose Vein
Severity Score (AVSS)16 and Venous Clinical Severity Score
(RVCSS),17 respectively. The AVSS (AVVQ) was completed by
the patient with assistance from the Vascular Specialist
Nurse if required; the RVCSS was completed by the Vascular
Specialist Nurse.
Patient satisfaction was measured using a Likert scale
patient satisfaction questionnaire (Fig. 1). Complications
were recorded during a patient’s routine follow up. Patients
were followed up to 12 weeks following the procedures as
per study protocol.
Randomisation
Randomisation took place on the day of surgery by way of
sealed opaque envelopes generated from a table of random
numbers.18 Each patient completed the AVSS and RVCSS on
the day of surgery. Every participant was measured for a
Class 2 above knee stocking pre-operatively and the stock-
ing was brought into the treatment room. The sealed
110 Madu Onwudike et al.

RADIOFREQUENCY ABLATION
POST- TREATMENT SATISFACTION QUESTIONNAIRE

This questionnaire is to help us to assess the benefit from this procedure and thereby improve practice.

1.a) How painful was the radiofrequency ablation procedure

(Please indicate using the scale on your right where ‘7’ is 0 1 2 3 4 5 6 7
the worst possible type of pain and ‘0’ is no pain at all) no pain worst pain

b) How long did the pain last (minutes)………… (hours)……………… (days)…………

please specify

c) How would you rate your improvement week 1

0 1 2 3 4 5 6 7
no improvement definite improvement

d) How would you rate your improvement week 2

0 1 2 3 4 5 6 7
no improvement definite improvement

e) How would you rate your improvement week 4

0 1 2 3 4 5 6 7
no improvement definite improvement

f) How would you rate your improvement week 6

0 1 2 3 4 5 6 7
no improvement definite improvement

2. How satisfied have you been with the procedure

0 1 2 3 4 5 6 7
not at all very satisfied

3. Do you regret having had the procedure

7 6 5 4 3 2 1 0
no regret definitely regret

4. Would you recommend the procedure to others

0 1 2 3 4 5 6 7
no strongly
recommend
5. Please tell us if you experienced any untoward effects from this radiofrequency ablation procedure

…………………………………………………………………………………………………………………
…………………………………………………………………………………………………………………

Please complete and return this questionnaire to the Vascular Nurse

Specialist
or alternatively to:

Figure 1. Radiofrequency ablation post-treatment satisfaction questionnaire.

envelope was opened by the patient at the completion of
the procedure. Apart from the post-operative compression,
every other aspect of the treatment and follow up was
identical for both arms. The vein to be treated was marked
pre-operatively using a portable Ultrasound Machine
(SonositeÒ MicroMaxx Bothel, WA, USA).
RFA procedure
The Covidien (Medtronic) VNUS Closure FastÔ system
(Covidien LP, 710 Medtronic Parkway Minneapolis, MN,
USA) was used for delivering the RFA treatment. Tumescent
anaesthesia (using 20 mL 1% lignocaine þ 1:200,000
adrenaline in 450 mL of 0.9% NaCl þ 10 mL of 8.4% sodium
bicarbonate) was administered under ultrasound guidance.
The patient was placed in Trendelenburg position prior to
the commencement of thermal ablation. Delivery of energy
to the radiofrequency (RF) probe is fully automated and
delivered via the VNUS RFGPlus RF generator. Each effective
RFA cycle lasts 20 s and is programmed to achieve the
target temperature of 120 within five seconds. Any inef-
fective RFA cycle was repeated. The most proximal segment
received two cycles of treatment. During a cycle of RFA the
operator applied pressure over the treated area. A single 4/
0 absorbable suture was applied to the puncture site to
prevent bleeding. A class II compression stocking (23e
32 mmHg ankle pressure) was applied to patients rando-
mised to the compression stocking group. The compression
stocking was worn for two weeks, day and night during the
first week, and daytime only during the second week. The
RCT on Compression Therapy after Radiofrequency Ablation of Varicose Veins
patient was usually discharged from hospital within two
hours of the procedure being completed.19 Each patient
was given a single 40 mg dose of enoxaparin peri-
operatively. No analgesics were prescribed but patients
were advised to take paracetamol as required.
For every truncal vein the accessible linear segment was
treated, except when the vein was too close to the skin to
avoid thermal skin injury; for the great saphenous vein
(GSV), treatment did not extend beyond the level of mid
calf to avoid saphenous neuropathy. No adjunctive sclero-
therapy or phlebectomy was performed.
Follow up
Each patient was given a patient satisfaction questionnaire
to complete at home and this questionnaire was submitted
when they attended for review at two, and 12e14 weeks
post-operatively in accordance with study protocol. During
these reviews any complications were recorded, and the
size of any bruising documented. DUS was performed at
two weeks and 12e14 weeks, except where a complication
such as DVT was suspected prior to this date. The AVSS and
RVCSS were completed at the 12e14 week follow up.7
Power calculation and statistics
This trial was a parallel group non-inferiority RCT. The null
hypothesis was that the outcome of RFA treatment of
varicose veins without post-treatment compression was no
worse than the same procedure with compression.
Assuming 90% power, a Type 1 error of 5%, and a planned
success rate of 97.5% for patients receiving compression,
the required number of patients to show that the success
rate in patients not receiving compression was no less than
2.5% lower than this in absolute terms, was 40 in each arm
of the trial. However, to increase the robustness of the
results including potential dropout and given the low
probability of adverse events in this trial, ethical approval
was granted to extend the total sample size to 100.
The analysis of the obliteration of the target vein and all a
priori important variables of interest was by multivariable
logistic regression, a standard statistical method for dealing
with outcomes that can be expressed as success/failure and
which can jointly account for the effects of two or more
independent variables.20 Analysis of QoL data was by
multivariable linear regression. Forward stepwise and
backward elimination approaches were undertaken to
confirm the consistency of findings of the regression ana-
lyses. Because the assumptions of normality were violated
by some variables, non-parametric tests were also carried
out. Given the small proportion of loss to follow up and the
high success rate of the treatment, no attempt was made to
include patients with missing data in the analyses, as it
would have made very little differences to the inferences.
All analyses were performed blind, on an intention to treat
basis, using Stata software (StataCorp LLC, College Station,
TX, USA).21
111
RESULTS
The CONSORT flow diagram is shown in Fig. 2.
There were no significant differences in the baseline
characteristics between the study arms prior to interven-
tion. Age and sex distributions were similar. The mean AVSS
and RVCSS were 18 and 10 for “Compression” and 16 and
10 for “No compression” groups, respectively (Table 1).
Comorbidities encountered in the study population were
evenly distributed between the two groups and included
atrial fibrillation, alcohol abuse, bleeding veins, diabetes,
Raynaud’s syndrome, aortic aneurysm, previous DVT in a
contralateral limb, spina bifida, and thrombophlebitis.
The great saphenous vein was the sole target vein in
approximately 80% of cases. There was a higher proportion
of CEAP C3eC5 in the present patient group because of the
restriction imposed by service commissioners which meant
that many C2 patients were denied NHS treatment except
when complicated by bleeding or thrombophlebitis. This
policy was also responsible for the slower than anticipated
rate of recruitment into the study. Of the procedures, 99%
were performed using tumescent local anaesthesia. One
patient in the control arm had general anaesthesia because
of needle phobia.
Overall, a 94% follow up rate was achieved at 12e14
weeks (93% vs. 94% in the Compression vs. No compression
groups, respectively, p ¼ .89), and 7% did not return the
questionnaire. Occlusion rates of the target veins at two
weeks were identical to the rates at 12e14 weeks. Occlu-
sion at two weeks, therefore, accurately predicted occlusion
at 12e14 weeks.
The primary outcome data (Table 2) show a comparable
occlusion rate of 98% achieved in both groups. Similarly,
patient satisfaction (92% vs. 91%; p ¼ .72), pain score (1.9
vs. 2.0; p ¼ .92), and post-procedural pain free state (45%
vs. 49%; p ¼ .52) were not significantly different between
the Compression and No compression groups, respectively.
On the other hand, two patients (4%) on the Compression
arm and one patient (2%) on the No compression arm
regretted the procedure (p ¼ .48). The QoL and venous
disease severity (AVSS 6 vs. 5.0 [p ¼ .57]; RVCSS 3 vs. 4
[p ¼ .46]) were also similar at the end of 12e14 weeks
follow up. There was no difference in complications be-
tween the two groups (Table 2). Two patients had calf DVT
at their two week scans. No anticoagulation was given.
Repeat scan after four weeks showed no propagation. At 12
weeks there was no residual DVT. Two other patients had
thrombus extending from the treated GSV into the CFV.
These two patients were anticoagulated for six weeks and
repeat scan showed no extension. None of the patients
found with DVT on scanning had any symptoms. One pa-
tient provided a satisfaction score but did not attend for the
scan to determine the primary outcome of vein occlusion.
Patient characteristics (age, gender, comorbidities, diag-
nosis, vein diameter, baseline varicose vein or compression
treatment, and pre-operative AVSS and RVCSS) did not
predict the success or failure of the treatment. Similarly,
112 Madu Onwudike et al.

Eligibility Assessed for eligibility (n = 183) Excluded (n = 83)

Foam Sclerotherapy (n = 52)
Open surgery (n = 7)
Declined to participate (n = 7)
Ulcers requiring compression
Enrollment

bandaging (n = 5)
Enrolled (n = 100) Unable to consent or apply
stocking (n = 4)
Pregnant (n = 4)
High BMI > 40 (n = 3)
DVT on the day (n = 1)
Randomized
(Day of Surgery) (n = 100)
Allocation

Compression Stocking (n = 51) No Compression Stocking (n = 49)

Follow-Up –12 weeks

Received allocated intervention (n = 51) Received allocated intervention (n = 49)

Did not receive allocated intervention (n = 0) Did not receive allocated intervention (n = 0)

Follow up (n = 48)
Follow up (n = 46)
Lost to follow-up (No Follow-up US) (n = 3)
Lost to follow-up (No Follow-up US) (n = 3)
Did not comply with treatment (n = 0)
Did not complete AVSS questionnaire (n = 4)
Did not complete AVSS questionnaire (n = 3)
Did not complete RVCSS (n = 3)
Did not complete RVCSS (n = 2)
Analysis

Analysed (n = 48) Analysed (n = 46)

Excluded from analysis (primary outcome Excluded from analysis (primary outcome
measure not recorded) (n = 3) measure not recorded) (n = 3)

Figure 2. CONSORT flow diagram of patient enrolment, allocation, and analysis to study three month outcome with or
without compression stockings after radiofrequency ablation for varicose veins in a randomised controlled trial. BMI ¼
body mass index; DVT ¼ deep vein thrombosis; AVSS ¼ Aberdeen Varicose Vein Severity Score; RVCSS ¼ Revised
Venous Clinical Severity Score; US ¼ ultrasound.

trial characteristics (length of procedure, volume of
tumescent, treatment allocation, painfulness of procedure)
did not affect the primary outcome.
KruskaleWallis equality of populations rank tests of
various variables at 10e12 weeks post-procedure (Table 3)
showed that vein occlusion and satisfaction with the pro-
cedure significantly predicted follow up AVSS score. One
unit increase in vein occlusion and satisfaction with pro-
cedures reduced the AVSS score by 17 (p ¼ .010) and 2
(p < .001), respectively. None of the other parameters were
observed to have a significant effect on follow up AVSS
score
Similarly, Table 4 shows that vein occlusion and satis-
faction with procedure predicted a decrease in RVCSS score
by 0.678 (p ¼ .001) and 5.64 (p ¼ .007), respectively. There
was a tendency for high pre-procedure RVCSS to be asso-
ciated with higher RVCSS at the end of the follow up period,
but this relationship was not linear. Both AVSS and RVCSS
were higher for those patients in whom occlusion of the
target vein was not achieved.
No patient suffered a specific complication from
compression, but nine patients (20% of patients in the
compression arm) complained about difficulty wearing the
stocking and/or discomfort associated with wearing it. One
patient described wearing the stocking as “awful,” and two
patients complained of excessive itching.
Patients were asked (see Fig. 1) to rate their improve-
ment on weeks 1, 2, 4, and 6 post-procedure on a scale of
0e7 with 0 being “No improvement” and 7 being “Definite
improvement.” This, combined with data on when they
became pain free, could be surrogate markers for when the
patients returned to normal activity. By the end of Week 1,
62% of the Compression group and 63% of the No
compression group scored 7. By the end of the second week
the respective figures were 94% and 95%. There was
therefore no significant difference between the two groups.
DISCUSSION
The present study has shown that the target vein occlusion
rate was not influenced by whether post-procedure
compression was worn or not following RFA of varicose
veins, where phlebectomies have not been performed
adjunctively. Similarly, there was no evidence that QoL
RCT on Compression Therapy after Radiofrequency Ablation of Varicose Veins 113

Table 1. Baseline characteristics of patients studied for three month outcome with or without compression stockings after
radiofrequency ablation for varicose veins in a randomised controlled trial

Variables Compression No compression Difference (A e B)* p valuey

A (n [ 51) B (n [ 49)
Age e years 62.6  14.0 58.1  16.6 4.4 (1.7 e10.5) .15
Gender males 27 (53) 28 (57) 0.04 (0.23 e 0.15) .69
CEAP .78
2 7 (14) 7 (14)
3 11 (22) 11 (23)
4 28 (55) 22 (45)
5 3 (6) 6 (12)
6 2 (4) 3 (6)
Venous system .26
GSV 42 (82) 38 (78)
GSV þ SSV 3 (6) 1 (2.0)
GSV þ AAGSV 1 (2.0) 0 (0.0)
SSV 5 (10) 10 (20)
Diameter of largest vein to be treated e mm 8.9  3.4 8.9  3.4 0.07 (1.26 e 1.40) .91
Compression stockings prior to allocations 14 (28) 13 (27) .55
Duration of surgery e min 43  15 41  13 2 (4 e 7.0) .64
AVSS 18  8 16  7 2 (5 e 1) .19
RVCSS 10  3 10  4 0 (2 e 1) .74
Data are presented as n (%) or mean  standard deviation unless stated otherwise. AAGSV ¼ anterior accessory of the great saphenous vein;
AVSS ¼ Aberdeen Varicose Vein Severity Score; CEAP ¼ Clinical-Etiological-Anatomical-Pathophysiological classification of chronic venous
disorders; GSV ¼ great saphenous vein; RVCSS ¼ Revised Venous Clinical Severity Score; SSV ¼ small saphenous vein.
* Difference (A  B) refers to value in compression arm (control) minus value in experimental (no compression) arm presented as mean (95% CI).
y
p value of difference between experimental and control arm (based on t test for continuous data and Fisher’s exact test for categorical data).

Table 2. Twelve to fourteen week follow up data by allocation to radiofrequency ablation treatment for varicose veins with or
without compression stockings post treatment in a randomised controlled trial

Outcomes Compression No compression Difference p valuez

A (n [ 48) B (n [ 46) A e By
Occlusions 47 (98) 45 (98) 1.0
Patient satisfaction .72
Very satisfied 38 (75) 37 (76)
Satisfied 6 (12) 4 (8)
Neutral 1 (2) 2 (4)
Somewhat satisfied 0 (0) 1 (2)
Not satisfied 3 (6) 1 (2)
Regret having had procedure* .48
0 2 (4) 1 (2)
6 2 (4) 2 (4)
7 44 (86) 42 (86)
Pain score 22 22 1.0
Duration of pain .52
No pain 23 (45) 24 (49)
12 h 4 (8) 6 (12)
24 h 4 (8) 1 (2)
One week 20 (39) 18 (37)
AVSS 66 56 0 (2 e 3) .57
RVCSS 32 43 1 (1 e 1) .46
DVTx
Below knee 1 (2) 1 (2) 0.00 (0.09 e 0.09) 1.0
Above knee 1 (2) 1 (2) 0.00 (0.09 e 0.09) 1.0
Data are presented as n (%) or mean  standard deviation unless stated otherwise. AVSS ¼ Aberdeen Varicose Vein Severity Score; DVT ¼ deep
vein thrombosis; RVCSS ¼ Revised Venous Clinical Severity Score.
* Regret rate calculated from patients’ answers to question 3 “Do you regret having had the procedure” in radiofrequency ablation post-treatment
satisfaction questionnaire (Fig. 1).
y
Difference (A  B) refers to value in compression arm (control) minus value in no compression (experimental) arm presented as mean (95% CI).
z
p value of difference between experimental and control arm (based on t test for continuous data and Fisher’s exact test for categorical data); p
value  .050 is considered significant.
x
DVTs were picked up at the two week scan in asymptomatic patients. No residual DVTs were seen at the 12e14 week scan.
114 Madu Onwudike et al.

Table 3. KruskaleWallis equality of population rank tests for Table 3-continued

follow up Aberdeen Varicose Vein Severity Score (AVSS) at
Variable Patients e n p*
10e12 weeks after radiofrequency ablation for varicose veins
No 2
Variable Patients e n p* Yes 91
Painfulness of procedure .51
Age group .40
0e2 52
18 e 29 4
3e4 29
30 e 39 5
5e7 11
40 e 49 11
Satisfaction with procedure .001
50 e 59 24
0 4
60 e 69 22
3 1
70 e 79 17
4 3
80 11
6 10
Gender .30
7 75
Male 51
Female 42 AAGSV ¼ anterior accessory of the great saphenous vein;
Baseline CEAP .98 AVSS ¼ Aberdeen Varicose Vein Severity Score; CEAP ¼ Clinical-
Varicose veins 13 Etiological-Anatomical-Pathophysiological classification of chronic
Oedema 22 venous disorders; DVT ¼ deep vein thrombosis; GSV ¼ great
Pigmentation of eczema, etc. 47 saphenous vein; RF ¼ radiofrequency; RVCSS ¼ Revised Venous
Healed venous ulcer 7 Clinical Severity Score; SSV ¼ small saphenous vein.
Active venous ulcer 4 *p  .05 is regarded as significant.
Diagnosis .54
GSV 75
GSV þ SSV 3 scores, patient satisfaction, and complications were inferior
GSV þ AAGSV 1 in the group that had no post-procedure compression.
SSV 14
Comorbidities .23
The benefits of endovenous techniques in the treatment
No 84 of varicose veins are now established.22,23 Endovenous
Yes 9 ablation (RFA and EVLT) causes venous occlusion through
Previous varicose vein treatment .080 intimal thermal injury, thrombosis, and subsequent fibrosis
No 75 of the vein. While external pressure applied at the time of
Yes 18
Compression use before surgery .25
procedure may be beneficial,24 the role of compression post
No 69 thermal ablation has not been established.25
Yes 24 A RCT in patients with GSV incompetence not associated
Diameter of vein e mm .61 with ulceration, who were treated with EVLT, favoured a
<7 16 minimum 48 h compression therapy duration, although the
7 e 8.5 30
8.5 e 10.3 25
greatest benefit was achieved with one week of compres-
10.3 22 sion.26 It may be said that the improvement in symptoms
Pre-operative AVSS .77 noted with four hours, 48 h, or one week compression
0 e 11 20 therapy is part of the natural healing process independent
12 e 16 27 of duration of compression. The present trial, for the first
17 e 20 19
21 e 37 37
time, has proposed that compression therapy may not be
Pre-operative RVCSS .35 required in patients treated exclusively with RFA for vari-
0e9 43 cose veins.
10 9 With comparable baseline characteristics, the present
11 e 13 23 study showed a target vein occlusion rate of 98% with or
14 e 20 18
Length of surgery e min .71
without compression at 12 week follow up. This is consis-
<30 14 tent with the findings of Kokkosis and Schanzer, whose no
30 e <45 48 compression arm achieved 100% occlusion rate compared
45 e <60 18 with 91% in the compression group following endovenous
60 e <75 12 laser ablation.13 Ayo and colleagues14 reported 100% oc-
75 1
Number of RF cycles .070
clusion rate in both arms, compression and no compression.
0e9 51 While their study may be generalisable to endothermal
10 e 12 26 ablation (91% RFA and 9% EVLT), the present study applies
13 e 16 16 specifically to patients treated wholly by RFA. The present
Volume of tumescent e mL .13 results, which confirm Ayo’s findings, strongly suggest that
<250 22
250 e <450 44
not employing compression therapy following RFA does not
450 e 600 27 reduce the rate of target vein occlusion. They also suggest
Vein occlusion .001 that reported non-occlusion of target vein (2% in each
group) is not related to the use of compression therapy. The
RCT on Compression Therapy after Radiofrequency Ablation of Varicose Veins 115

Table 4. KruskaleWallis equality of population rank tests for Table 4-continued

follow up Revised Venous Clinical Severity Score (RVCSS) at
Variable Patients e n p*
10e12 weeks after radiofrequency ablation for varicose veins
5e7 11
Variable Patients e n p* Satisfaction with procedure .001
0 4
Age group .14
3 1
18 e 29 3
4 3
30 e 39 5
6 10
40 e 49 12
7 75
50 e 59 24
Vein occlusion .007
60 e 69 17
No 2
70 e 79 12
Yes 92
Gender .030
Male 53 AAGSV ¼ anterior accessory of the great saphenous vein;
Female 42 AVSS ¼ Aberdeen Varicose Vein Severity Score; CEAP ¼ Clinical-
Baseline CEAP 95 .12 Etiological-Anatomical-Pathophysiological classification of chronic
Varicose veins 13 venous disorders; DVT ¼ deep vein thrombosis; GSV ¼ great
Oedema 22 saphenous vein; RF ¼ radiofrequency; RVCSS ¼ Revised Venous
Pigmentation of eczema, etc. 48 Clinical Severity Score; SSV ¼ small saphenous vein.
Healed venous ulcer 7 *p  .05 is regarded as significant.
Active venous ulcer 5
Diagnosis .57
GSV 76
GSV þ SSV 4
GSV þ AAGSV 1 present study also explored factors that may be associated
AAGSV 14 with short term non-occlusion in both groups. It was found
Comorbidities .080 that age, comorbidities, vein diameter, length of procedure,
No 85
Yes 10
number of RF cycles, or recurrent varicose veins did not
Previous varicose vein treatment .22 affect success or failure in both groups of patients. The two
No 77 failures (one in each group) had fewer RF cycles, suggesting
Yes 18 that a shorter length of target vein available for treatment
Compression use before surgery .35 may be associated with failure. Technical reasons such as
No 69
Yes 26
optimum catheter position, incorrect technique, incorrect
Diameter of vein e mm .43 limb position, and ineffective tumescent application are
<7 18 possible causes of primary failure.27 This is similar to re-
7 e 8.5 30 ports from another retrospective study using prospectively
8.5 e 10.3 25 registered data with one year follow up reported in 2017.28
10.3 22
Pre-operative AVSS .10
Approximately 92% of patients were satisfied with the
0 e 11 20 procedures. This was consistent with low pain score (under
12 e 16 27 2) in both groups and a comparable regret rate. Post-
17 e 20 19 operative pain had resolved in over 60% of patients in
21 e 27 29 both groups within 24 h of the procedure. These findings
Pre-operative RVCSS .007
0e9 43
suggest that compression therapy does not contribute to-
10 9 wards better pain control. One RCT29 was identified
11 e 13 23 (n ¼ 79) that assessed pain at two days, 14 days, and six
14 e 20 20 weeks comparing compression for two weeks with no
Length of surgery e min .17 compression after an initial 24 h bandage in patients un-
<30 14
30 e <45 48
dergoing EVLT. The study reported a higher pain score in the
45 e <60 19 no compression arm. The same study also reported greater
60 e <75 13 satisfaction in the compression arm at two days (4.44 vs.
75 1 4.15), two weeks (4.33 vs. 3.95), and six weeks (4.59 vs.
Number of RF cycles .20 4.18). However, the study may have had insufficient power
0e9 51
10 e 12 28
to test the hypothesis. Ye K et al.30 compared elastic
13 e 16 16 bandage for 24 h followed by elastic compression stocking
Volume of tumescent e mL .14 for at least two weeks (n ¼ 200) with elastic bandage alone
100 e <250 22 (n ¼ 200), and reported a comparable pain score at 24 h
250 e <450 45 and lower pain score at one week with compression ther-
450 e 600 28
Painfulness of procedure .91
apy following EVLT. However, pain score data were collected
0e2 53 from only approximately 40% of patients. Significantly, they
3e4 29 did not find any difference in QoL improvement nor in the
Continued “Mean time to return to work.” Unlike the present study, Ye
116
K studied exclusively C2 patients and also performed “high
ligation” (in addition to EVLA), in all their patients. However,
similar to the present study, they did not perform adjunc-
tive phlebectomy or sclerotherapy.
The present findings agree with those of Ayo et al.14 in
terms of the effect on quality of life and disease severity
scores (AVSS, RVCSS), and also confirm their finding that
compression had no effect on post-procedure pain. There
was no increased rate of complications in the No
compression group, as also found by Krasznai et al.,12
Kokkosis and Schanzer,13 and Ayo.14 There are, however,
significant differences in methodology between the present
study and that of Krasznai et al. in that the No compression
arm did receive initial compression bandaging for four
hours and they did not assess the occlusion rate of the
target veins. With no difference in outcome between the
groups in the present study, and given that 20% of patients
would find the wearing of compression stockings uncom-
fortable, the prescription of compression post-RFA may no
longer be justifiable.
Factors predicting the 12 week follow up clinical severity
and QoL scores were explored, and it was found that suc-
cessful occlusion of the treated target vein and patient
satisfaction predicted improved AVSS and RVCSS scores.
Those who are satisfied with the treatment outcome are
therefore more likely to have had successful target vein
occlusion and, in turn, low AVSS and RVCSS scores. It could
be argued, therefore, that significantly improved AVSS and/
or RVCSS should be accepted as a successful outcome
without the need for post-procedure duplex scanning. Only
in those in whom there is no significant fall in these scores,
should a scan become necessary. Extrapolating from the
present study, this should be w2% of the patient popula-
tion. A high pre-operative RVCSS was found to be associ-
ated with a higher (but still significantly reduced) post-
procedure RVCSS score among those with successful oblit-
eration of the target vein. This is not thought to have a
significant clinical implication, except to be aware of the
association. There is no obvious explanation for the finding
of post-procedure RVCSS in general being higher for males
compared with females. No obvious clinical or practical
application of this finding is seen, and it is unclear whether
future studies will confirm the finding.
The method of randomisation and the fact that both the
chief investigator and the statistician were blinded to the
allocated group reduced the risk of bias. The low dropout
rate in this study reduced the risk of type 2 error. The study
was not powered to detect the difference in DVT rate, given
its very low incidence. One limitation of the study is that it
is from a single centre and it only reports short term results.
In this regard, it is similar to the study by Ayo et al., which
had a follow up period of 90 days. Long term follow up
analysis may give further insight into differences in success
rates based on compression therapy use. The present au-
thors plan recall of patients for clinical and sonographic
review after 24 months. Meanwhile, the results of this
study may provide reliable scientific evidence which was
not available during preparation of the recently published
Madu Onwudike et al.
American guidelines on compression therapy after endo-
thermal ablation of varicose veins.31
The present authors accept that the place or duration of
compression post-RFA is far from settled, but expect that
this study will contribute to development of the body of
knowledge on the subject. Whereas earlier studies
concentrated on the duration of compression, the present
study and that of Ayo et al.14 have moved the discussion on
to answering the question of whether compression is
required at all following RFA in situations where phlebec-
tomies have not been performed. This is consistent with a
publication by the National Institute for Health and Care
Excellence (NICE) in the UK,3 which highlighted the knowl-
edge gap in the role of compression following endothermal
ablation. This study is also a partial response to the Euro-
pean Society for Vascular Surgery (ESVS) guidelines,32 which
recommended the need for further studies in this area. If
the present findings are confirmed by larger studies, it is
likely that the current recommendation of post-procedural
compression for all cases of open surgery and endove-
nous superficial vein procedures will be revised.
In conclusion, the physician and patient reported out-
comes following RFA without compression are no worse
than with compression. This trial supports the conclusion
that the widely practised use of compression post RFA may
add no clinical benefit to the patients. However, a much
larger study, preferably a multicentre trial, may be required
to confirm this conclusion.
CONFLICT OF INTEREST
None.
FUNDING
Royal Bolton Hospital Research Grant (Reference IRAS
69699).
REFERENCES
1 Callam M, Ruckley C, Harper D, Dale J. Chronic ulceration of the
leg: extent of the problem and provision of care. BMJ 1985;290:
1855e6.
2 Callam M. Epidemiology of varicose veins. Br J Surg 1994;81:
167e73.
3 National Institute for Health and Clinical Excellence (NICE).
Varicose Veins: diagnosis and management e clinical guideline
[CG168]. https://www.nice.org.uk/guidance/cg168/chapter/1-
recommendations. [Accessed 8 April 2019].
4 Rasmussen L, Bjoern L, Lawaetz M, Blemings A, Lawaetz B,
Eklof B. Randomized trial comparing endovenous laser ablation of
the great saphenous vein with high ligation and stripping in pa-
tients with varicose veins: short-term results. J Vasc Surg 2007;46:
308e15.
5 Trevor J, Rhodes J, Hardy J, Makin G. Postoperative limb
compression in reduction of haemorrhage after varicose vein
surgery. Ann R Coll Surg Engl 1993;75:119e22.
6 Shouler P, Runchman P. Varicose veins: optimum compression
after surgery and sclerotherapy. Ann R Coll Surg Engl 1989;71:
402e4.
7 Partsch H, Hafner J, Lattimer C, Mosti G, Neumann M, Urbanek T,
et al. Indications for medical compression stockings in venous and
lymphatic disorders: an evidence-based consensus statement.
Phlebology 2008;27:193e219.
RCT on Compression Therapy after Radiofrequency Ablation of Varicose Veins
8 Huang T, Chen S, Bai C, Wu C, Tam K. The optimal duration of
compression therapy following varicose vein surgery: a meta-
analysis of randomized controlled trials. J Vasc Surg 2013;57:
1174e5.
9 El-Sheikha J, Nandhra S, Carradice D, Acey C, Smith G,
Campbell B, et al. Compression regimes after endovenous ablation
for superficial venous insufficiency e a survey of members of the
Vascular Society of Great Britain and Ireland. Phlebology 2015;31:
16e22.
10 Biswas S, Clark A, Shields D. Randomised clinical trial of the
duration of compression therapy after varicose vein surgery. Eur J
Vasc Endovasc Surg 2007;33:631e7.
11 Hamel-Desnos C, Guias B, Desnos P, Mesgard A. Foam sclero-
therapy of the saphenous veins: randomised controlled trial with
or without compression. Eur J Vasc Endovasc Surg 2010;39:500e7.
12 Krasznai A, Sigterman T, Troquay S, Houtermans-Auckel J,
Snoeijs M, Rensma H, et al. A randomised controlled trial
comparing compression therapy after radiofrequency ablation for
primary great saphenous vein incompetence. Phlebology 2015;31:
118e24.
13 Kokkosis A, Schanzer H. Compression therapy is not necessary
after endovenous ablation therapy for the treatment of varicose
veins. Clin Surg 2017;2:1700.
14 Ayo D, Blumberg S, Rockman C, Sadek M, Cayne N, Adelman M,
et al. Compression versus no compression after endovenous
ablation of the great saphenous vein: a randomized controlled
trial. Ann Vasc Surg 2017;38:72e7.
15 Labropolous N, Tiongson J, Pryor L, Tassiopoulos AK, Kang SS,
Ashraf Mansour M, et al. Definition of venous reflux in lower-
extremity veins. J Vasc Surg 2003;38:793e8.
16 Smith J, Garratt A, Guest M, Greenhalgh R, Davies A. Evaluating
and improving health-related quality of life in patients with
varicose veins. J Vasc Surg 1999;30:710e9.
17 Rutherford R, Padberg F, Comerota A, Kistner R, Meissner M,
Moneta G. Venous severity scoring: an adjunct to venous outcome
assessment. J Vasc Surg 2000;31:1307e12.
18 Higgins J, Green S. Review: cochrane handbook for systematic
reviews for interventions, Version 5.1.0, published 3/2011. In:
Julian PT, Higgins, Sally Green, editors. Research synthesis
methods, vol. 2; 2011. p. 126e30.
19 Joh J, Kim W, Jung I, Park K, Lee T, Kang J. Consensus for the
treatment of varicose vein with radiofrequency ablation. Vasc
Specialist Int 2014;30:105e12.
20 McCullagh P, Nelder JA. Generalized linear models. 2nd ed., vol. 37.
Chapman and Hall/CRC Press; 1989.
21 StataCorp. Stata statistical software: release 13. College Station, TX:
StataCorp LP. - Open Access Library; 2013 [Internet]. Oalib.com.
117
2019, http://www.oalib.com/references/5814356. [Accessed 9
April 2019].
22 Rautio T, Ohinmaa A, Perälä J, Ohtonen P, Heikkinen T, Wiik H,
et al. Endovenous obliteration versus conventional stripping
operation in the treatment of primary varicose veins: a random-
ized controlled trial with comparison of the costs. J Vasc Surg
2002;35:958e65.
23 Pan Y, Zhao J, Mei J, Shao M, Zhang J. Comparison of endovenous
laser ablation and high ligation and stripping for varicose vein
treatment: a meta-analysis. Phlebology 2013;29:109e19.
24 Passariello F, Goldman M, Mordon S, Corcos L, Vaghi M, Zeh R.
The mechanism of action of LASER and radiofrequency in great
saphenous vein thermal ablation. Acta Phlebol 2010;11:35e9.
25 El-Sheikha J, Carradice D, Nandhra S, Leung C, Smith G,
Campbell B, et al. Systematic review of compression following
treatment for varicose veins. Br J Surg 2015;102:719e25.
26 Bakker NA, Schieven LW, Bruins RMG, Van der Berg M,
Hissink RJ. Compression stockings after endovenous laser abla-
tion of the great saphenous vein: a prospective randomized
controlled trial. Eur J Vasc Endovasc Surg 2013;46:588e92.
27 Taha A, Elbadawy A, Hasaballah A. Endovenous radiofrequency
ablation of lower extremity varicose veins: short-term outcomes of
the initial experience. Egypt J Surg 2018;37:185.
28 Jin H, Ohe H, Hwang J, Kim S, Kim J, Park S, et al. Radio-
frequency ablation of varicose veins improves venous clinical
severity score despite failure of complete closure of the saphenous
vein after 1 year. Asian J Surg 2017;40:48e54.
29 Elderman J, Krasznai A, Voogd A, Hulsewé K, Sikkink C. Role of
compression stockings after endovenous laser therapy for primary
varicosis. J Vasc Surg 2014;2:289e96.
30 Ye K, Wang R, Qin J, Yang X, Yin M, Liu X, et al. Post-operative
benefit of compression therapy after endovenous laser ablation for
uncomplicated varicose veins: a randomised clinical trial. Eur J
Vasc Endovasc Surg 2016;52:847e53.
31 Lurie F, Lal BK, Antignani PL, Blebea J, Bush R, Caprini J, et al.
Compression therapy after invasive treatment of superficial veins
of the lower extremities: clinical practice guidelines of the
American venous Forum, society for vascular surgery, American
College of phlebology, society for vascular medicine, and inter-
national union of phlebology. J Vasc Surg 2019;7:17e28.
32 Wittens C, Davies AH, Bækgaard N, Broholm R, Cavezzi A,
Chastanet S, et al. European Society for Vascular Surgery. Editor’s
choice e management of chronic venous disease: clinical practice
guidelines of the European Society for Vascular Surgery (ESVS).
Eur J Vasc Endovasc Surg 2015;49:678e737.