Eur J Vasc Endovasc Surg (2020) 59, 73e80

RANDOMISED CLINICAL TRIAL

Post-procedural Compression vs. No Compression After Radiofrequency

Ablation and Concomitant Foam Sclerotherapy of Varicose Veins: A
Randomised Controlled Non-inferiority Trial
a,b,*
Toni Pihlaja , Pekka Romsi a, Pasi Ohtonen b,c
, Janne Jounila d, Matti Pokela a

a
Department of Vascular Surgery, Oulu University Hospital, Finland
b
Medical Research Centre Oulu, University of Oulu, Oulu, Finland
c
Division of Operative Care, Oulu University Hospital, Oulu, Finland
d
Department of Surgery, Raahe Regional Hospital, Finland

WHAT THIS PAPER ADDS

This randomised controlled, non-inferiority trial compared post-procedural compression with no compression
applied to the leg after radiofrequency ablation of a truncal vein and concomitant foam sclerotherapy to
tributaries. In terms of safety and efficacy, results were similar with and without post-operative compression.

Objective: To compare post-operative compression with no compression, after radiofrequency endothermal

ablation (RFA) of a truncal varicose vein and concomitant foam sclerotherapy of the tributaries.
Methods: This prospective randomised controlled, non-inferiority trial recruited patients from two centres in Northern
Ostrobothnia, Finland. Patients with clinical class C2eC4 chronic venous disease were randomised to receive no
compression after the operation, or to receive compression stockings continuously for two days, and then, during the
daytime for five days. In follow up visits, additional foam sclerotherapy was performed for symptoms of distal
incompetence. Patients were followed up for six months. The primary outcome was occlusion of the RFA treated
truncal vein at six months. Secondary outcomes were return to full activity within 14 days, Aberdeen Varicose Vein
Questionnaire (AVVQ) score, post-operative pain, need for painkillers, and postprocedural complications.
Results: Of 177 included patients, 90 were allocated to post-operative compression and 87 to no compression. At
six months, both groups showed 100% occlusion rates in RFA treated truncal veins (95% confidence
interval
0.043e0.042). Within 14 days of treatment, full physical activity was achieved by 87% of the
compression group and 81% of the no compression group, (p ¼ .29). At six months, the AVVQ scores were
comparable and significantly improved in both groups, compared with baseline. Pain scores were comparable
between groups, in day to day analyses, and they were significantly lower in both groups on day 10,
compared with pre-operative pain caused by varicose veins. On average, post-operative pain medication was
used for 2.3 days and for 2.8 days in the compression and no compression groups, respectively (p ¼ .28).
Complications throughout the six month follow up were comparable between groups, although skin rash/
blisters occurred more often in the compression group (p ¼ .01).
Conclusion: After treating C2eC4 varicose veins with RFA and concomitant foam sclerotherapy, no post-
operative compression was non-inferior to post-operative compression, in terms of safety and efficacy.
ClinicalTrials.gov Identifier: NCT02890563

Keywords: Compression stockings, Foam sclerotherapy, Radiofrequency ablation, Varicose veins

Article history: Received 9 May 2019, Accepted 14 August 2019, Available online 18 October 2019
Ó 2019 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.

* Corresponding author. Department of Vascular Surgery, Oulu University
Hospital, Box 21, FIN-90029 OYS, Finland.
E-mail address: toni.pihlaja@ppshp.fi (Toni Pihlaja).
1078-5884/Ó 2019 European Society for Vascular Surgery. Published by
Elsevier B.V. All rights reserved.
https://doi.org/10.1016/j.ejvs.2019.08.020
INTRODUCTION
Post-operative compression is the standard care after
endovenous ablation of superficial venous insufficiency.
Compression is intended to facilitate target vein occlusion
and reduce pain, swelling, and bruising. However, recent
reviews have found low or no evidence for the for
74 Toni Pihlaja et al.

recommending an optimal post-operative treatment after METHODS

endovenous ablation.1e4 Patients might find post-operative
compression uncomfortable, and compression can cause
post-operative side effects, such as itching, bruising, skin
irritation, and paraesthesia,5 which can lower compliance
with treatment.6 Lately, the role of post-operative
compression has been questioned,7 and the National Insti-
tute for Health and Clinical Excellence has recommended
further research on post-operative compression after
endovenous ablation of varicose veins.
Previous studies of post-operative compression after
endovenous ablation have focused either on endothermal
ablation5,8e11 or foam sclerotherapy,6,12 but trials of com-
bined treatment without post-operative compression are
lacking. The rationale for a combined treatment of endo-
thermal ablation and concomitant foam sclerotherapy is to
reduce the need of additional treatment in follow up
visits.13,14 In this prospective randomised, non-inferiority
trial, the safety and efficacy of post-operative treatment
without compression was evaluated, after radiofrequency
endothermal ablation (RFA) of a truncal vein and concom-
itant foam sclerotherapy to distal insufficiency.
This two centre, randomised controlled, non-inferiority trial
evaluated the efficacy and safety of post-operative care
without compression, after truncal vein RFA and concomitant
distal foam sclerotherapy. Patients were randomly allocated to
either the No Compression Group (NCG) or Compression
Group (CG). Patients were followed for six months. Before
enrolment, the trial was approved by the local Ethics
Committee.
Patients
Study subjects were recruited from venous outpatient
clinics, between August 2016 and May 2018, in Oulu Uni-
versity Hospital and in Raahe Regional Hospital, Finland. The
patient selection and allocation procedures are shown in
Fig. 1. Written informed consent was obtained from all
patients before randomisation. All patients who received
the allocated interventions were included in the analyses.
Duplex ultrasound and vein mapping were performed on
all patients in the standing position by a vascular outpatient
clinic physician, and reflux was defined as > 0.5 s flow

Enrolment
Assessed for eligibility (n=309)

Excluded (n=124)
Did not meet inclusion criteria (n=90)
Declined to participate (n=25)
Other reasons (n=9)

Randomised (n=185)

Allocation

Allocated to no compression group (n=91) Allocated to compression group (n=94)

Received allocated intervention (n=87) Received allocated intervention (n=90)
Did not receive allocated intervention: Did not receive allocated intervention:
Cancelled intervention (n=4) Cancelled intervention (n=4)

Four weeks follow up

Analysed (n=87) Analysed (n=90)

Four weeks data missing (n=1) Four weeks data missing (n=1)
Excluded from analysis (n=0) Excluded from analysis (n=0)

Six months follow up

Analysed (n=87)
Analysed (n=90)
Withdrew consent (n=1)
Lost to follow up (n=2)
Lost to follow up (n=1)
Excluded from analysis (n=0)
Excluded from analysis (n=0)

Figure 1. Consort diagram of patient selection and allocation procedures. Of the 90 patients who did not meet inclusion criteria, 31 patients
had no suitable truncal vein for radiofrequency ablation, 23 patients were considered better suited for isolated foam sclerotherapy, 12
patients were using antithrombotics other than acetylsalicylic acid, nine patients had a BMI >35, seven patients had truncal vein diameter
over 12 mm, six patients had CEAP 5e6, and two patients had a history of DVT. BMI ¼ body mass index; CEAP ¼ Comprehensive Clas-
sification System for Chronic Venous Disorders; DVT ¼ deep vein thrombosis.
Post-rocedural Compression Trial
reversal. Patients were eligible for inclusion if they were older
than 18 years of age and had truncal vein incompetence
suitable for endothermal ablation. Concomitant foam sclero-
therapy was performed for distal incompetence in all patients
with symptomatic visible varicosities or tortuous areas in the
saphenous trunk. Other inclusion criteria were: disease clin-
ical class C2eC4 according to the Clinical, Etiologic, Anatomic
and Pathophysilogic classification;15 patient suitability for
RFA16 and foam sclerotherapy;17 and provided written
informed consent. Exclusion criteria included a history of
pulmonary embolism or deep venous thrombosis; antith-
rombotics, other than acetylsalicylic acid (ASA); BMI > 35;
truncal vein diameter > 12 mm, measured 5 cm from the
saphenofemoral or saphenopopliteal junction; and pregnancy.
Patients were randomly allocated (1:1 ratio) to treatment
groups, using sealed, consecutively numbered, opaque en-
velopes. The envelopes were prepared by a study nurse, and
treatments were assigned according to a computerised
random number generator, created by a biostatistician.
Neither the nurse nor the biostatistician was involved in the
clinical care of the patients. Stratified, block randomization
was used. Stratification was performed by site and number
of treatable legs. A random permuted block size of 2, 4, 6,
and 8, within strata, was employed. For patients who
required treatment in two legs the study leg was rando-
mised, and both legs were treated post-operatively ac-
cording to the randomisation.
Interventions and follow up
All patients were treated by RFA performed under ultra-
sound guidance with a VNUSÒ ClosurefastÔ (VNUS Medical
Technologies, San Jose, California, USA) radiofrequency
catheter, according to standard procedural guidelines.18 The
catheter was introduced into the target vein through a 7
French sheath using an ultrasound guided puncture.
Tumescent anaesthesia was injected inside the saphenous
fascial compartment before endothermal ablation. After
RFA, multiple i.v. cannulae (20 or 22G) were inserted under
ultrasound guidance to pre-marked positions to the tribu-
taries and concomitant foam sclerotherapy was performed
with a 1% or 3% sodium tetradecyl sulphate solution
(FibroveinÔ, STD Pharmaceutical Products Ltd, Hereford,
United Kingdom) with Tessari’s technique.19 Using 1:3 so-
lution/air ratio. Concomitant foam sclerotherapy was per-
formed for patients who had visible distal varicosities, major
distal perforators, or tortuous veins, in addition to the RFA.
After treatment, the sheath introduction hole and foam
sclerotherapy punctures were covered with local self-ad-
hesive dressings (MeporeÒ,Molnlycke Health Care, Goth-
enburg, Sweden). Post-operatively, patients either received
no compression at all or compression with individual off the
shelf (measured from the ankle, calf, and thigh areas) class 2
thigh length compression stockings, continuously for two
days, and then, during the daytime for five days. All patients
were advised to walk 30 min post-operatively and regularly
on the remainder of the operation day. Intensive exercise
was denied for all patients for one week after the operation.
75
At four weeks and at six months post-operatively, pa-
tients returned to the clinic to drop off their questionnaires
(follow up sheet and Aberdeen Varicose Vein Question-
naire) and undergo an examination. Duplex ultrasound was
performed at every visit. Between visits, patients were
advised to contact the corresponding clinic whenever
necessary. In the follow up visits, additional foam sclero-
therapy was performed when untreated varicose veins were
detected, and subsequent post-operative compression was
carried out according to the primary randomisation.
Outcomes
Baseline characteristics are described in Table 1. The primary
outcome was occlusion of the RFA treated truncal vein at six
months. The secondary endpoints were a disease specific
questionnaire (Aberdeen Varicose Vein Questionnaire,
AVVQ), return to full activity within 14 days, post-operative
pain measured with a visual analogue scale (VAS), the need
for painkillers post-operatively, and postprocedural major
and minor complications, including deep venous thrombosis,
thrombophlebitis of the untreated tributaries, paraesthesia,
puncture site infection, haematoma, and rash or blisters. The
AVVQ scores were calculated after dropping the first ques-
tion (i.e., a leg manikin drawing), because patients had re-
ported problems in interpreting that question.20 Visible
pigmentation developing after the procedures was moni-
tored in follow up visits. For the compression group,
compliance with compression stockings and possible
compression related complications were recorded.
Sample size calculation
In this non-inferiority trial, a 93% rate of RFA treated truncal
vein occlusion was assumed in both groups. A 10% non-
inferiority margin was used, with a ¼ .05, and power ¼ 0.8.
Furthermore, a 5% dropout rate was assumed during the six
month follow up. According to these assumptions, 85 patients
per group were required for the analyses.
Statistical methods
Summary measurements are presented as the mean and
standard deviation (SD), unless otherwise stated. All analyses
were performed according to the intension to treat (ITT)
principle. Between group comparisons of continuous variables
were analysed with the Student t test or Welch’s t test. The
latter test was used when the p value was <.05, but Levene’s
test showed unequal variances. Categorical data were analysed
with Pearson’s c2 test or Fisher’s exact test, as appropriate.
A repeated measures mixed model (RMMM) ANOVA was
used for repeatedly measured data, with time, group, and
time*group as fixed effects and the patient as a random effect.
The covariance pattern was chosen according to Akaike’s In-
formation Criterion. The Kenward-Roger method was used for
calculating the degrees of freedom. The RMMM was used for
between group comparisons of repeatedly measured data.
Two tailed p values are presented. Treatment outcome dif-
ferences with 95% confidence intervals (95% CI) were calcu-
lated for all primary and secondary outcomes. All analyses
76 Toni Pihlaja et al.

Table 1. Baseline characteristics of the study population

Characteristic Compression n [ 90 No compression n [ 87

Age, y, mean (SD) [range] 46.0 (12.3) [24, 72] 49.8 (12.0) [28, 78]
Female, n (%) 72 (80) 72 (83)
Weight, kg, mean (SD) [range] 74.6 (12.7) [50, 105] 73.4 (13.0) [53, 110]
Height, cm, mean (SD) [range] 169.1 (7.9) [151, 190] 168.4 (8.7) [144, 191]
BMI, kg/m2, mean (SD) [range] 25.9 (3.4) [18.9, 34.3] 25.8 (3.7) [20.3, 34.9]
Bilateral leg treatment, n (%) 38 (42) 38 (44)
Study leg, n (%)
Right 50 (56) 42 (48)
Left 40 (44) 45 (52)
Previous treatment in study leg, n (%) 15 (17) 21 (24)
Current smoking, n (%) 11 (12) 11 (13)
ASA medication, n (%) 4 (4) 5 (6)
Diabetes, n (%) 3 (3) 5 (6)
CEAP, n (%)
C2 26 (29) 27 (31)
C3 57 (63) 54 (62)
C4 7 (8) 6 (7)
RFA treated trunk, n (%)
GSV/AASV 74 (82) 78 (90)
SSV 11 (12) 3 (3)
GSV/AASV þ SSV 5 (6) 6 (7)
Diameter, mm, mean (SD) [range]
GSV/AASV 6.5 (1.5) [4, 12] 6.7 (1.5) [4, 11]
SSV 5.8 (1.7) [3, 9] 6.0 (2.0) [3, 10]
AVVQ, score, mean (SD) [range] 15.4 (6.9) [1.9, 32.9] 15.7 (7.0) [3.3, 35.4]
AASV ¼ anterior accessory saphenous vein; ASA ¼ acetylsalicylic acid; AVVQ ¼ Aberdeen Varicose Vein Questionnaire; BMI ¼ body mass index;
CEAP¼ Clinical-Etiological-Anatomical-Pathophysiological classification of Chronic Venous Disorders (for this study, only C “Clinical” was
recorded); GSV ¼ great saphenous vein; RFA ¼ radiofrequency ablation; SD ¼ standard deviation; SSV ¼ small saphenous vein.

were performed with SPSS for windows (Released 2018. IBM with duplex ultrasound. In both groups, 100% occlusion was
SPSS Statistics for Windows, Version 25.0, IBM Corp., Armonk, observed (95% CI -0.043e0.042) (Table 2).
NY, USA) and SAS (version 9.3, SAS Institute Inc., Cary, NC, USA).

Disease specific questionnaire

RESULTS
Truncal vein occlusion
Post-operatively, truncal vein occlusion was evaluated by
duplex ultrasound and a patent superficial truncal vein
>4 cm long at the saphenopopliteal or saphenofemoral
junctions was considered to be an incomplete result. The
average RFA treated truncal vein length in the thigh area
(the great or anterior accessory saphenous vein) was
33.8 cm (SD 11.0) in CG and 33.4 cm (SD 11.3) in NCG. The
average RFA treated small saphenous vein length was
20.3 cm (SD 6.6) in CG and 23.1 cm (SD 6.2) in NCG. No RFA
procedure technical failures were reported. At six months,
the radiofrequency treated truncal vein(s) was assessed
At six months, the AVVQ scores were better in both groups
compared with baseline (p < .001 in both groups). In the
CG and NCG, respectively, the baseline scores were 15.4 (SD
6.9) and 15.7 (SD 7.0) (p ¼ .75), and at six months, the
scores were 5.8 (SD 5.5) and 5.3 (SD 5.3) (p ¼ .66) (Table 2).
Time to return to full activity
In the CG and NCG, full physical activity was achieved by 55
(61%) and 46 (55%) patients (p ¼ .43), respectively, within
seven days, and by 72 (87%) and 67 (81%) patients, respec-
tively, within 14 days (p ¼ .29) (Table 2). Full physical activity
was described as the ability to perform all normal and work

Table 2. Primary and secondary outcomes

Outcomes Compression (n [ 90) No compression (n [ 87) Difference (%) (95% CI) p

Primary outcome
Truncal vein occlusion at six months, n (%) 90 (100) 87 (100)
0.043e0.042 1.0
Secondary outcomes
AVVQ, score at six months, mean (SD) 5.7 (5.5) 5.3 (5.2) 0.3 (
1.4e1.9) .76
Return to full activity in 14 days, n (%) 72 (87) 67 (81) 6.0 (
5.4e17.3) .29
Pain 1e10 days, mm, mean (SD) 16.9 (16.3) 20.8 (15.6) 3.9 (
0.9e8.7) .11
Need for painkillers, days, mean (SD) 2.3 (2.9) 2.8 (3.5)
0.5 (
1.5e0.4) .28
AVVQ ¼ Aberdeen Varicose Vein Questionnaire; CI ¼ confidence interval; SD ¼ standard deviation.
Post-rocedural Compression Trial 77

days, and the average daily needs for painkillers were 2.3 (SD
100 No compression
2.9) in the CG and 2.8 (SD 3.5) in the NCG (p ¼ .28) (Table 2).
Compression
90

80 ptime < .001 Foam sclerotherapy

70 pgroup = .11
Foam sclerotherapy was performed concomitantly with RFA
ptime × group = .99
60 in 76 (84%) patients in the CG and 73 (84%) patients in the
VAS – mm

NCG (p ¼ .92). During follow up additional foam sclero-

50
40
30
20
10
0 in the CG and NCG, respectively (p ¼ .95).
Preop. 1 2 3 4 5 6 7 8
Post operative day
Figure 2. Median post-operative pain day to day in Compression
and No compression groups with 25th to 75th percentiles.
VAS ¼ visual analogue scale.
related activities, and in addition, all physical exercises that
patients were able to perform before the treatment.
Post-operative pain and pain medication
Post-operative pain was measured daily for ten days post-
operatively with a visual analogue scale. The mean pain
scores were 16.9 mm (SD 16.3) in the CG and 20.8 mm (SD
15.6) (p ¼ .11) in the NCG (Table 2). Fig. 2 shows the day to
day median post-operative pain with 25th to 75th percentiles
for both groups. On day 10, pain was significantly lower in
both groups compared with the pre-operative pain caused by
varicose veins (CG: p ¼ .001; NCG: p ¼ .02). The need for
painkillers (NSAID or paracetamol) was monitored for 10
therapy was administered to 27 (31%) and 20 (23%) pa-
tients in the CG and NCG, respectively, at four weeks
(p ¼ .25), and 15 (17%) and 13 (15%) patients, respectively,
at six months (p ¼ .76). The volume of foam sclerotherapy
used is described in Table 3. Foam sclerotherapy was not
administered at any time point in 7 (8%) and 6 (7%) patients
9 10
Pigmentation
Visible pigmentation following foam sclerotherapy was
monitored at follow up visits. In the CG and NCG, respec-
tively, visible pigmentation was observed in 30 (33%) and 42
(48%) patients at the four week visit (p ¼ .04) and in 20
(23%) and 28 (32%) patients at six month visit (p ¼ .18).
Compliance and side effects with compression therapy
Of the 90 patients in the CG, 88% (95% CI 79.2e93.0) re-
ported compliance with therapy. One or more side effects
related to compression therapy were reported by 18 (20%)
patients, including seven (8%) with rash or blisters, 13 (15%)
with discomfort, and 10 (11%) with itching. Because of side
effects, nine (10%) patients terminated compression ther-
apy earlier than prescribed. The other nine patients
with compression therapy side effects chose to either
forego compression for one or more days or continue
compression as prescribed, despite the complications. No
patient in the NCG required post-operative compression.

Table 3. Foam sclerotherapy in study population

Time of administration and strength Compression group, No compression group, p

of foam sclerosant used n (mean, mL) [SD] n (mean, mL) [SD]
Concomitant sclerotherapy
Foam sclerosant 1% 50 (2.9) [1.6] 44 (3.4) [1.7]
Foam sclerosant 3% 30 (3.2) [1.7] 33 (2.7) [1.3]
Total (1% þ 3%)* 76 (5.1) [3.1] 73 (5.3) [3.5]
Four week follow up
Foam sclerosant 1% 24 (2.8) [1.4] 18 (2.5) [0.9] .49
Foam sclerosant 3% 6 (2.4) [1.5] 7 (3.6) [1.5] .19
Total (1% þ 3%)* 27 (3.1) [1.6] 20 (3.5) [2.3] .60
Six month follow up
Foam sclerosant 1% 13 (2.9) [1.1] 9 (2.7) [0.94] .77
Foam sclerosant 3% 3 (3.7) [2.1] 6 (1.9) [0.67] .13
Total (1% þ 3%)* 15 (3.2) [1.4] 13 (2.8) [1.1] .69
All time points
Foam sclerosant 1% 62 (4.0) [2.5] 58 (3.8) [2.1] .56
Foam sclerosant 3% 32 (3.8) [2.6] 39 (3.2) [1.9] .28
Total (1% þ 3%)* 83 (4.5) [2.7] 81 (4.3) [2.8] .62
Values are: n ¼ the number of patients that received foam; mean, mL ¼ mean volume of foam administered; SD ¼ standard deviations per time
point.
* Total ¼ all patients who received 1%, 3%, or both 1% and 3% foam sclerosant solutions at the time point indicated. For totals and all time
points, patients are only counted once, regardless of the number of applications they received.
78
Complications
All complications that occurred throughout the six month
follow up are described in Table 4. One patient in the NCG
(p ¼ .31) developed popliteal venous thrombosis, four days
after receiving RFA and concomitant foam sclerotherapy.
This patient was treated with oral anticoagulants, according
to local protocol. Medical records of this patient showed
that a larger volume of 3% foam sclerosant was adminis-
tered in the infragenicular area than recommended by the
guideline.21 Three patients developed thrombophlebitis in
untreated tributaries (two patients in CG and one patient in
NCG, p ¼ .58). These patients were treated with subcu-
taneous low molecular weight heparin for six weeks, ac-
cording to local protocol.
DISCUSSION
To the authors’ knowledge, this is the first randomised
controlled, non-inferiority trial to compare post-operative
compression and no compression at all treatments after
RFA and concomitant foam sclerotherapy. The primary
outcome results showed successful occlusion of the RFA
treated truncal vein(s) in 100% of patients in both groups at
six months. Previous studies showed that RFA treatment
was effective for truncal vein occlusion22 and the present
authors hypothesised that, in this study, administration of
additional foam sclerotherapy to the distal insufficiency
would further enhance truncal vein occlusion. Throughout
the six month follow up, the two groups showed no dif-
ferences in all major and minor complications, although the
incidence of rash or blisters was higher in the CG than in the
NCG. In addition, one patient in the NCG who developed
popliteal thrombosis post-operatively was treated with an
oral anticoagulant for three months, and the thrombi
resolved six weeks after starting treatment. Overall, the
incidence of thrombotic events was comparable to that
reported in a recently published review.23
Earlier studies found that post-operative pain was
reduced in patients who received post-operative compres-
sion for longer times following endovenous laser ablation
(EVLA), compared with patients who received shorter
compression times or no compression.9e11 In the present
Table 4. Complications during the six month follow up
Complications Compression (n [ 90)
Major complications
Deep vein thrombosis,* n (%) 0 1 (1)
Thrombophlebitis,y n (%) 2 (2)
All major complications, n (%) 2 (2)
Minor complications
Infection, n (%) 0 0
Haematoma, n (%) 0 2 (2)
Rash or blisters, n (%) 7 (8)
Paraesthesia, n (%) 4 (4)
All minor complications, n (%) 11 (12)
CI ¼ confidence interval.
* Deep vein thrombosis was treated with oral anticoagulation.
y
Thrombophlebitis was observed in untreated tributaries and required subcutaneous treatment with low-molecular-weight heparin (LMWH).
Toni Pihlaja et al.
study, after RFA, there was no difference between the
groups in the day to day pain analysis. The different findings
between studies might be explained by the different tem-
peratures created in EVLA and RFA, where EVLA creates
much higher catheter temperature peri-operatively.24
Overall, low day to day post-operative pain values were
found in both groups, and on day 10, the pain scores were
significantly lower in both groups, compared with the pre-
operative pain caused by the varicose veins.
The foam volumes and the need for additional foam
sclerotherapy treatment in follow up visits were compara-
ble between groups. Visible pigmentation following foam
sclerotherapy was observed more often in the NCG than in
the CG at the four week follow up, but the difference was
no longer significant at the six month follow up. Visual
assessment tools13 were not used in this trial. Thus, the
effect of post-operative compression on the visual appear-
ance of veins could not be evaluated in detail.
In the CG, 88% of patients complied with the protocol for
post-operative compression stockings. This compliance rate
was better than that found in an earlier study.6 Good
compliance was probably related to the relatively short
compression time (i.e., 7 days in total). However, even in
this setting, 18 (20%) patients in the CG reported
compression related side effects.
Recently published guidelines of the American Venous
Forum4 recommended post-operative compression after
endothermal ablation and foam sclerotherapy with grade II
recommendations and level of evidence C. Moreover, the
2015 ESVS guidelines25 found benefit in post-operative
compression after EVLA and varicose vein surgery, thus
giving a class I recommendation with level of evidence A to
post-procedural compression following varicose vein sur-
gery, endovenous truncal ablation, and foam sclerotherapy.
In this study, after RFA and foam sclerotherapy, where 93%
of patients had C2eC3 disease and 7% C4 disease, no sig-
nificant differences were found in the primary or secondary
outcomes between study groups. Based on these findings, it
is considered that after RFA and/or foam sclerotherapy,
most patients with C2eC3 venous disease can be treated
without any post-operative compression and this might
apply to C4 disease as well. Longer follow up may be
No compression (n [ 87) Difference (%) (95% CI) p

1.1 (
6.2e3.1) .31
1 (1) 1.1 (
4.2e6.7) .58
2 (2)
0.1 (
6.0e5.7) .97
0 (
4.2e4.1) 1.0

2.3 (
8.0e2.1) .24
0 7.8 (2.0e15.2) .01
4 (5)
0.2 (
7.3e6.9) .96
6 (7) 5.3 (
3.7e14.5) .23
Post-rocedural Compression Trial
required in the future to assess possible long term differ-
ences between groups, mainly for the efficacy of the
treatment. In the present authors’ clinic, patients with more
severe C5eC6 disease are treated under an urgent protocol
and were not included in this study. It is also generally
acknowledged that compression still plays an important role
when treating venous ulcers. Regarding concomitant treat-
ment, some institutions prefer phlebectomies over foam
sclerotherapy and the authors conclude that the role for
post-operative compression following phlebectomies
cannot be addressed in the light of this study.
This study had some limitations. First, only four patients
in the CG and five patients in the NCG used acetylsalicyclic
acid (ASA). Therefore, the potential benefits of post-
operative compression could not be assessed in patients
who used antiplatelet or other antithrombotic treatments.
Second, in this study, the maximum truncal vein diameter
was limited to 12 mm, BMI to 35, and patients with a his-
tory of deep vein thrombosis (DVT) or stage C5 to C6 dis-
ease were excluded. Of the 309 patients who were assessed
for eligibility, 12 (4%) were using antiplatelets other than
acetylsalicylic acid, nine (3%) had BMI over 35, seven (2%)
had truncal vein diameter over 12 mm, six (2%) had C5 to
C6 stage disease, and two (1%) had a history of DVT. Pa-
tients with a history of DVT were excluded because of usual
administration of subcutaneous low molecular weight
heparin post-operatively. Despite the exclusions, the study
population represents the most commonly treated patients
with C2 to C4 stage disease treated with RFA and foam
sclerotherapy in daily practice.
Based on these results, it was concluded that, after
treating C2eC4 varicose veins with RFA and concomitant
foam sclerotherapy, no post-operative compression was
non-inferior to post-operative compression, in terms of
safety and efficacy.
CONFLICT OF INTEREST
None.
FUNDING
This study was supported by state funding for the university
level (Oulu University Hospital; grant No: 24771/K47859).
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Eur J Vasc Endovasc Surg (2020) 59, 80

COUP D’OEIL

Multiple Visceral Artery Stenoses in Williams-Beuren Syndrome

Tina Cohnert *, Gregor Siegl
Dept. of Vascular Surgery, Graz Medical University, Graz University Hospital, Graz, Austria

A B

CT
CT SMA
RA

SMA RA

IMA

IMA

A 41 year old woman with Williams-Beuren Syndrome (gene deletion at 7q11.23, deletion in the elastin gene) was
transferred with suspected Dunbar syndrome. Due to psychomotor retardation a reliable history was impossible.
Aortography 14 years previously (A) had already shown stenoses of the coeliac trunk (CT), superior mesenteric artery
(SMA), inferior mesenteric artery (IMA) and right renal artery (RA). Recent MRA (B) reconfirmed multiple stenoses. In
this obese patient (BMI 37.2) with concomitant subvalvular and valvular aortic stenosis, caudal regression syndrome
and cystoplasty, multidisciplinary consensus recommended conservative treatment as the BMI contradicted intestinal
claudication.
Endovascular therapy in Williams-Beuren Syndrome carries a high risk of rupture or restenosis.

* Corresponding author. Dept. of Vascular Surgery, Graz Medical University, Auenbruggerplatz 29, 8036 Graz, Austria.
E-mail address: Tina.cohnert@medunigraz.at (Tina Cohnert).
1078-5884/Ó 2019 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.
https://doi.org/10.1016/j.ejvs.2019.10.017