Original Article
Phlebology
Foam sclerotherapy
Glen Alder and Tim Lees
Abstract
Foam sclerotherapy is a minimally invasive treatment for lower limb varicose veins. Current evidence indicates that its
efficacy may not be as high as surgery or endovenous ablation. The minimally invasive nature of the treatment however
means that it has a wide application, and it can be particularly useful in patients who are not suitable for other types of
treatment. NICE guidelines recommend its use as a second line after endovenous ablation. Complication rates are low
and most of these are of little clinical consequence.
Keywords
Foam Sclerotherapy, varicose veins, techniques, complications
Introduction
Variations of sclerotherapy have been used in the treat-
ment of varicose veins for over 150 years, with sub-
stances such as acid, iodine and tannins originally
injected into the veins to induce thrombus formation.1
These techniques were, unsurprisingly, accompanied by
high rates of unfavourable side effects and the practice
was effectively abandoned until the early 20th century.
Limited work with alternative sclerosants continued
until the development of sodium tetradecyl sulphate
(STS) in 1946.2 STS is an anionic surfactant that acts
upon the lipid molecules in the cells of the vein wall,
leading to inflammatory destruction of the inner vein
wall, thrombus formation and eventual sclerosis of the
vessel. STS is the active ingredient in Sotradecol,
sold under the trade name Fibro-vein in the UK in
concentrations of 0.2%, 0.5%, 1% and 3%.
Pioneering work by George Fegan in the 1960s and
the advent of duplex ultrasonography in the 1980s
lead to further development and acceptance of the tech-
nique and it is now recognised as a safe and effective
alternative to surgery in the treatment of varicose
veins.3 Polidocanol is an alternative sclerosant which
is frequently used for the treatment of varicose veins
as a liquid or foam preparation.
Foam sclerotherapy has potential benefits over
other common treatments for varicose veins such as
surgery and endovascular interventions. It is minim-
ally invasive, involving only cannulation of truncal
and varicose veins and is therefore very suitable for
outpatient treatment; because of its minimally inva-
sive nature and few side effects it is suitable for
patients who may be unfit for the other types of
treatment; it is easily repeatable; and it is of low
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2015, Vol. 30(2S) 18–23
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DOI: 10.1177/0268355515589536
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cost. This review examines some of the common tech-
niques of foam sclerotherapy along with the evidence
for its efficacy.
Techniques
All patients should undergo duplex scanning in accord-
ance with previous agreed guidelines for the investiga-
tion of lower limb venous disease.4 Patients who have
truncal incompetence in addition to localised varicos-
ities should receive treatment to both the truncal vein
and the varicosities. The veins are cannulated under
ultrasound control and local anaesthesia. The authors
use an 18 gauge venflon for the truncal veins and a
22 gauge butterfly needle for the varicosities but differ-
ent sizes can be used down to 32 gauge for the smallest
thread veins. The needles are inserted first and the leg is
then elevated in a sling on a drip stand and the patient
placed in reverse Trendelenberg position.
The foam is then injected into the veins in a piece-
meal fashion. One to two millilitres of foam at a time
are inserted at each site and this is repeated until all the
veins to be treated have been filled with foam, as seen
on ultrasound scanning. The authors rarely use more
than 14 ml of foam although others have reported using
up to 20 ml without any significant side effects.5 Some
phlebologists prefer to compress the saphenofemoral or
saphenopopliteal junction for a period following
Freeman Hospital, Newcastle upon Tyne, UK
Corresponding author:
Glen Alder, Freeman Hospital, Freeman Road, Newcastle upon Tyne,
NE7 7DN, UK.
Email: glen.alder@nuth.nhs.uk
Alder and Lees
injection in order to prevent proximal migration of the
foam into the deep veins. The authors prefer not to do
this on the presumption that release of such compres-
sion could lead to a bolus of foam travelling into the
deep veins whereas small amounts of foam in the deep
veins is deactivated by blood very rapidly. It is import-
ant, however, to monitor the progress of the foam with
ultrasound and to stop injecting once a significant
amount of foam has reached the level of the deep
veins. Following each injection the patient is asked to
perform ankle dorsiflexions in order to pump blood
and any foam out of the deep veins.
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19
The foam is made by drawing up 0.5 ml of STS in a
2 ml syringe and 1.5 ml of air in another 2 ml syringe.
These are passed backwards and forwards across a
three-way tap approximately 25 times until the foam
is formed.
Following treatment the cannulae are removed.
The authors have tried many different methods of
compression and have found the most acceptable and
effective combination to be dental rolls taped over the
treated varicose and truncal veins and then a thigh-
length elastic compression stocking with a pressure of
18–24 mmHg at the ankle. This is left on for five days
undisturbed, the pressure rolls are then removed and
the stocking is worn during the day time for a further
seven days. Patients are warned that some local discom-
fort and thrombus formation within the treated veins
are very common and if this occurs, anti-inflammatory
analgesia is advised. The patient is reviewed a few
weeks later and any large areas of superficial venous
thrombosis can be aspirated.
Efficacy and cost-effectiveness
Current NICE guidelines state that ‘A review of the
data from the trials of interventional procedures indi-
cates that the rate of clinical recurrence of varicose
veins at 3 years after treatment is likely to be between
10–30%’. This guideline was developed with the aim of
giving healthcare professionals guidance on the diagno-
sis and management of varicose veins in the leg,
in order to improve patient care and minimise such
disparities in care across the UK.6 These guidelines rec-
ommend that patients to be considered for treatment
include those patients with symptomatic primary or
recurrent varicose veins, lower limb skin changes sec-
ondary to chronic venous insufficiency, superficial vein
thrombosis or venous leg ulcers. These patients should
undergo duplex ultrasound assessment to confirm the
diagnosis of varicose veins and the extent of truncal
reflux. Patients with confirmed venous incompetence
requiring treatment should be offered endothermal
ablation. If endothermal ablation is unsuitable, patients
should be offered foam sclerotherapy. If both endother-
mal ablation and sclerotherapy are unsuitable, patients
should be offered surgery. Compression hosiery should
only be offered if interventional treatment is unsuitable.
A recent randomised control trial (CLASS trial) of
798 patients across 11 centres in the UK was conducted
in order to compare the different treatment options for
varicose veins in terms of their effect on quality-of-life.
Outcomes for the trial were assessed at baseline, six
weeks and six months after treatment. The primary
outcomes were measured at six months using the
Aberdeen Varicose Veins Questionnaire (AVVQ),
EuroQoL Group 5-Dimension Self-Report
20
Questionnaire and Medical Outcomes Study 36-Item
Short-Forma Health Survey (SF-36). At six months,
the foam group had a significantly higher AVVQ
score than the surgery group, demonstrating the
worse disease-specific quality-of-life (effect size 1.74;
95% CI 2.97 to 0.50). There were no significant
differences in AVVQ score change when comparing
laser with surgery or laser with foam. At six weeks,
secondary quality-of-life outcomes were significantly
worse in the foam group as compared with surgery in
terms of AVVQ score (effect size 2.3; 95% CI 3.7 to
0.9). SF-36 scores at six weeks were significantly
lower in the surgery group when compared with laser,
thereby suggesting significantly worse quality of life.
At six months, there was no significant difference
between the groups in the venous clinical severity
score, suggesting no difference in residual disease
at this time point. Moreover, there were no significant
differences between the groups in the rates of serious
adverse events.7 The order of treatment priority
from the CLASS trial is therefore endovascular inter-
vention, followed by surgery, with foam sclerotherapy
the third choice, which is different to the current NICE
guidance.
A meta-analysis of 31 RCTs conducted in 2011 sug-
gested that there was little difference between minimally
invasive techniques and surgery for varicose veins in
terms of effectiveness or safety, and that further work
was required to determine the most cost-effective
option.8 A recent meta-analysis of 13 studies with a
combined total of 3081 randomised patients suggested
that UGFS, EVLA and RFA are at least as effective as
surgery in the treatment of great saphenous varicose
veins. However, due to large incompatibilities between
trials and different timepoint measurements for out-
comes, the evidence was lacking in robustness and it
was suggested that further randomised trials were
needed.9 In a recent study of 54 patients looking at
the effectiveness of UGFS on healing and recurrence
in the treatment of chronic venous ulcers, the 24-week
and 12-month estimated healing rates were 53% and
72%, respectively, with an estimated 12-month recur-
rence rate of 9.2%, and no major complications
reported, suggesting UGFS is a safe and effective
option for abolition of superficial reflux.10 A study of
UGFS in 391 limbs in 285 patients found recurrence
rates of 15.3% at 5–8 year follow-up, suggesting dur-
able results as per patient-reported outcomes.11 Also, a
study which randomised 60 patients to stripping under
GA or UGFS under LA found significantly earlier
return to normal activity (median two versus eight
days) in the UGFS group. The cost was also lower in
the UGFS group despite four patients developing reca-
nalisation that required further treatment.12 Systematic
reviews have suggested that there is little to choose
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Phlebology 30(2S)
between the minimally invasive techniques in terms of
efficacy or cost, and each offers a viable, clinically
effective alternative to surgery. There is also the sugges-
tion that UGFS might offer the most cost-effective
alternative to stripping, within certain time parameters,
but that further high-quality RCT evidence is needed.13
NICE guidelines suggest that the initial cost per patient
of UGFS would be approximately 60 compared to
85–135 for avulsion phlebectomy. Further differ-
ences in cost would arise if one treatment were shown
to lead to a higher probability of the need for retreat-
ment but due to a lack of clinical evidence this is not
explored further. Endothermal treatment is thought to
be the most cost-effective treatment option, with an
incremental cost-effectiveness ratio of 3161 per
QALY gained.14
Complications
The complications associated with UGFS include cere-
brovascular/neurological events, deep vein thrombosis
(DVT), thrombophlebitis, skin pigmentation, localised
phlebitis, bubble embolisation, pulmonary embolisa-
tion, myocardial infarction (MI), headache, infection
and systemic complications.
Cerebrovascular/neurological events
Such events are very rare but have been reported.
A transient ischaemic attack after foam injection
occurred in one patient in a case series of 1025 patients,
with complete clinical recovery within in 30 min.15
Post-treatment stroke has been reported in three
patients worldwide,16 all of whom were subsequently
diagnosed with a patent foramen ovale. In one
patient treated by foam sclerotherapy and ambulatory
phlebectomy, middle cerebral artery bubbles were
detected immediately after the procedure (treated with
tissue plasminogen activator) and in the other
two patients middle cerebral arterial ischaemic
change was confirmed. All three patients recovered
completely with no further neurological or thrombotic
events reported at follow-up ranging from three
months to two years. In a further case series study,
transient visual disturbance was reported in five
patients (twice in one patient) during or shortly
after treatment in 977 patients treated by foam
sclerotherapy.17
DVT and pulmonary embolism (PE)
The incidence of DVT following treatment with foam
sclerotherapy has been reported to be between 0.3 and
1%. Current evidence suggests that the incidence of
DVT is no higher following foam sclerotherapy than
Alder and Lees
after other varicose vein treatments.15,17 Pulmonary
embolism is rare following foam sclerotherapy, occur-
ring in less than 1% of patients (approximately 0.1%).
In one study, PE was reported in one patient in a case
series of 977 patients treated by foam sclerotherapy at
five weeks after treatment.17
A meta-analysis of published randomised controlled
trials and case series of the incidence of venous
thromboembolism following treatment of great saphe-
nous insufficiency by endovenous thermal ablation or
foam sclerotherapy suggest that the stratified incidence
of venous thromboembolism appears to be low
(<1%).18 In one study of treatment of 331 small saphe-
nous veins 2 medial gastrocnemius vein thromboses
occurred in symptomatic patients. Duplex also identi-
fied 5 medial gastrocnemius vein thromboses and 4 cases
of extension of small saphenous thrombus into the
popliteal vein. The authors conclude that patients with
medial gastrocnemius vein perforators, and those with
the small saphenous vein connecting directly to the
popliteal vein should receive a check ultrasound one
to two weeks after foam sclerotherapy.19 Encouraging
ankle dorsiflexion after foam injection to promote deep
venous flow may reduce the risk of DVT, though it is
considered inevitable that some foam will enter the deep
venous system. The authors also consider that it is
important to monitor perforating veins during the
foam injection in order to avoid inadvertent injection
of large volumes of foam into the deep system.
Thrombophlebitis and skin pigmentation
Superficial thrombophlebitis was reported in 7%
(17/230) of patients treated by foam sclerotherapy
within one week of the procedure compared with 0%
of 200 patients treated by surgery in an RCT of 430
patients18 (p < 0.001). In the authors’ experience, super-
ficial venous thrombosis is common although this may
not lead to specific symptoms or phlebitis. Superficial
thrombophlebitis presents with hard, elevated ‘lumpy’
areas of skin, erythema, pain and tenderness. It usually
responds to topical or systemic anti-inflammatory prep-
arations, and may improve with local aspiration of the
thrombus. Skin pigmentation occurs in up to 18% of
patients following foam treatment,21 although in many
patients this is minor and will improve with time. One
study reported an incidence of 6% (12/213) in patients
treated by foam sclerotherapy compared with 1%
(2/177) in patients treated by surgery.18 There is also
anecdotal evidence to suggest that aspiration of the
superficial thrombus may reduce the severity of skin
pigmentation changes. This complication is of no
major clinical significance but may be of significance
in those patients undergoing treatment of their varicose
veins for predominantly cosmetic reasons.
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21
Bubble embolisation
Bubble embolisation is felt to be a possible reason
for the rare neurological complications of foam sclero-
therapy that have been reported. One case series which
looked at 82 patients with right-to-left shunts found
that bubble embolisation occurred in 73% (60/82) of
patients. In the study, all patients with MCA emboli
detected by transcranial Doppler during endovenous
microfoam ablation subsequently received intensive
surveillance for microinfarction, including brain mag-
netic resonance imaging and measurement of cardiac
troponin-I. ‘Most’ bubbles were detected within
15 min of the foam injection and no new neurological
symptoms were detected at follow-up (1, 7 and/or 28
days).22 A case series of five patients using a modified
technique reported that in all patients bubbles entered
the right side of the heart in less than 60 s and contin-
ued for up to 50 min. None of the patients developed
any neurological or cardiac symptoms.23
Myocardial infarction
MI has not been reported as a complication in most
studies of foam sclerotherapy. In one unpublished
study referred to in a systematic review, a patient had
an MI 30 min after injection, but no further details were
available.24 A further study reports an unusual case
of persisting chest discomfort following UGFS in a
61-year-old woman which led to a diagnosis of non-
ST-elevation MI25 though again, further details are cur-
rently unavailable.
Headache, infection and systemic complications
Complications including coughing, chest tightness/
heaviness, panic attack, malaise and vasovagal fainting
have been reported at a rate of 0–3% across the studies
in the systematic review (follow-up ranged between one
month and five years).22 Groin infection was reported
in two patients treated by foam sclerotherapy and two
patients treated by surgery in the RCT of 73 patients at
median five-year follow-up.26 Headache was reported
in three patients immediately after the procedure in
the case series of 977 patients (this resolved in 24 h
after treatment by analgesia).17 Facial rash was
reported in one patient in the same case series.
The rash appeared 24 h after treatment and disappeared
spontaneously.
It has been suggested that adverse events following
UGFS may be related to the volume of foam injected
and that the use of carbon dioxide rather than air
to produce the foam may reduce the risk of neuro-
logical events, but there is a lack of robust evidence
to support this assertion. Current NICE guidelines
recommend that ‘during the consent process, clinicians
22
should inform patients that there are reports of tempor-
ary chest tightness, dry cough, headaches and visual
disturbance, and rare but significant complications
including myocardial infarction, seizures, transient
ischaemic attacks and stroke’.14
Summary
UGFS can be considered a safe and effective treatment
option for varicose veins,27 and its minimally invasive
nature makes it suitable for many patients who could
not be treated by other means. There is little definitive
evidence with regard to its longer term effectiveness
when compared to other treatment options such as sur-
gery or RFA/EVLA, although trials to date would sug-
gest it is not as effective as surgery and endovascular
treatments. Further research will help to define which
patients are best suited to foam sclerotherapy but the
authors tend to reserve it for patients with recurrent
varicose veins, patients who are not fit for other inter-
ventions, and for those who are on anticoagulants (as it
is not necessary to stop these prior to treatment).
Patients should be warned of common potential side
effects such as thrombophlebitis, skin pigmentation
changes and temporary headache and chest tightness
as well as rare but more serious complications such as
stroke, DVT, MI and seizures.
NICE guidelines currently recommend foam sclero-
therapy as a second line interventional treatment for
varicose veins, to be offered if the patient is not suitable
for RFA or laser.
Conflict of interest
None declared.
Funding
This research received no specific grant from any funding
agency in the public, commercial, or not-for-profit sectors.
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