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Foam sclerotherapy for ablation of the
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saphenous veins, varicose tributaries,
andperforating veins
HUW DAVIES, KATY DARVALL, AND ANDREW W. BRADBURY
35
35.1 Introduction 421
35.2 History 421
35.3 Sclerosants and mechanism of action 422
35.4 Foam preparation techniques 422
35.5 Technique 422
35.1 INTRODUCTION
Since the last edition of the American Venous Forum (AVF)
Handbook of Venous Disorders was published in 2008, there
have been major advances in the endovenous management of varicose veins (VVs). Foam sclerotherapy (FS) is
a versatile treatment that can be performed safely, quickly,
and inexpensively in an oce setting, and has become an
important part of the phlebologist’s armamentarium. e
aim of this chapter is to
1. Briey review the history of FS
2. Discuss the currently available sclerosants and
techniques
3. Present the results of FS from large observational and
randomized studies
4. Suggest how FS might t within a multimodality endo-
venous treatment oer
5. Make some recommendations regarding further
research
35.2 HISTORY
Sclerotherapy has been used to treat VVs since at least the
1850s. However, early sclerosants such as percholate of iron
or mercury, iodine, tannins, and carbonic acid were associated with an unacceptably high incidence of serious, even
35.6 Results of FS 424
35.7 Contraindications and sideeffects 424
35.8 Conclusion 426
References 426
life-threatening complications, such as tissue necrosis, sepsis, and pulmonary embolism. For this reason, it was not
until the introduction of modern safe sclerosants, such as
sodium tetradecyl sulfate (STS), in the 1960s that sclerotherapy gained widespread popularity. FS is thought to have been
rst described in 1939 by McAusland who, aer shaking a
bottle of sodium morrhuate, used the resultant froth to successfully treat telangiectasia. In 1944, Orbach described the
“air block” technique in which an intravenous injection of
air prior to the sclerosant was claimed to prevent dilution by
blood and prolong endothelial contact. Sigg described a similar “foam block” technique in 1949. In 1950, Orbach noticed
increased vasospasm (thought to be an important indicator
of success) with FS when compared with liquid sclerotherapy
(LS). In 1956, Flückiger emphasized the importance of leg
elevation to empty the VVs of blood and advised the retrograde injection of foam, which could then be massaged along
the leg in a proximal to distal direction. It was also noted
that decreasing bubble size increased bubble surface area
and endothelial contact, thereby producing more sclerosis
with less sclerosant. In 1957, Mayer and Brücke described
the use of a double piston syringe to produce what they
termed “microfoam.” In the 1990s, microfoam production
was further rened by Cabrera, Monfreux, and Tessari, and
Knight rst introduced the concept of ultrasound-guided FS
(UGFS).
detail.
1
Wollmann has reviewed the history of FS in more
2
421
422 Foam sclerotherapy for ablation of the saphenous veins, varicose tributaries, andperforating veins
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35.3 SCLEROSANTS AND MECHANISM
OF ACTION
In Europe, most phlebologists use “home-made” STS and/
or polidocanol (PD) microfoam for FS. In the United States,
Varithena, which is a commercially prepared 1% PD microfoam, has recently been approved by the Food and Drug
Administration (FDA). Sclerosants produce endothelial
damage, which exposes collagen and leads to activation of
platelets and the i ntrinsic coagulat ion pathway. e resulting
thrombosis and inammation eventually results in brosis
and obliteration of the vessel lumen. If intraluminal thrombosis is excessive, this can be associated with pain, dermal
pigmentation, clot propagation (risk of deep vein thrombosis [DVT]) and recanalization. Detergent sclerosants such as
STS and PD cause endothelial damage by altering cell wall
surface tension, leading to rapid overhydration (maceration). STS is a long-chain fatty acid salt, is painless to inject,
is usually used at concentrations of 1%–3%, and produces
maceration within 1 second of exposure. PD is a urethane
anesthetic agent, is painless to inject, is thought to be less
likely (than STS) to produce extravasation necrosis, and is
usually used at concentrations of 0.5%–3%. Injection of STS
or PD as a foam, as opposed to a liquid, results in the displacement of blood, so minimizing deactivation (binding)
by protein and maximizing contact with the endothelium
(“foam block eect”).
with similar side-eect proles.
3
Both STS and PD are well tolerated,
4
35.4 FOAM PREPARATION TECHNIQUES
e Tessari (Tourbillon) technique is probably the most
commonly use method for reproducibly making stable
(in 1–2 minutes) microfoam (Figure 35.1).5 Typically, two
(2–10-mL) syringes are connected via a three-way tap.
Room air is drawn into one syringe and liquid sclerosant
into the other. e use of sterile air, nitrogen, or carbon
dioxide has been advocated. However, they add cost and
complexity and, due to a lack of evidence, there is a range
Figure 35.1 Tessari technique. Note the 5-μm filter
between the syringe and tap for producing consistent
microfoam.
of views as to whether these adjuncts confer any benet in
terms of safety or clinical eectiveness.6 e air and sclerosant are mixed back and forth (usually around 20 times)
through the three-way tap to produce the microfoam. e
connector tap can be angulated to narrow the aperture in
order to produce smaller bubbles and so more stable, and
arguably more eective, microfoam. Alternatively, a 5-μm
bacterial lter can be interposed between the two syringes.
A number of other foam preparation methods have been
described, such as the Hamel-Desnos etal.’s double syringe
technique7 and the Monfreux’s “méthode MUS.”8 ere is
no clear evidence that one method is superior to the others,
and cost and convenience are arguably the most important
considerations. e most eective and commonly used
gas-to-sclerosant ratios appear to be 4:1 or 5:2, but this is
also an area where good-quality evidence is lacking. Lowsilicone syringes and connectors are preferred as silicone
destroys the surfactant arrangement of the foam lamellae,
so making it less stable.9 Varithena is a 1% PD foam made
with a proprietary blend of “physiological” gases and dispensed from a pressurized container. Varithena bubbles
are appreciably smaller than those found in “home-made”
foam and this, together with the absence of nitrogen, may
reduce the risks of air embolism.10 However, thus far, clear
evidence of benet in terms of safety and clinical eectiveness compared to “home-made” foam appears to be
lacking.
35.5 TECHNIQUE
Many FS techniques have been advocated and there is no
clear evidence as to which is the best. e authors have
settled on a method that they have found to be simple,
quick, safe, well-tolerated, and associated with excellent
long-term (5–8-year) outcomes. As with all UGFS techniques, duplex ultrasound with a high-frequency (5–15MHz) transducer and access to emergency resuscitation
equipment in case of anaphylaxis (very rare) are required.
e procedure starts by “marking up” the VV to be treated
with the patient in a standing position. With the aim of
introducing “fresh” microfoam at 10–20-cm intervals
along the trunk and major tributary VV to be treated,
intravenous cannulas are placed at strategic points under
local anesthetic and ultrasound guidance with the patient
in the supine and/or prone position. e size of cannulae to be used is determined by vein diameter and depth.
In a patient with “standard” great saphenous vein (GSV)
VVs, four cannulae are typically positioned in the GSV
as follows: 10–15 cm below the saphenofemoral junction;
just above the knee; just below the knee; and just above
the ankle. In general, the greater the diameter of the GSV,
the closer together the cannulae are placed. Where present, cannulae will also be placed in the anterior accessory
saphenous vein and in all of the major tributaries. If there
are extensive supercial varices, typically in the calf, then
these too will be cannulated. In a patient with “standard”
35.5 Technique 423
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small saphenous vein (SSV) VVs, the SSV is typically cannulated just distal to the saphenopopliteal junction, with
the cannula pointing caudally to minimize entry of foam
into the popliteal vein, and again in the distal SSV usually
just above the ankle or at the point of the distal incompetence (Figure 35.2). e leg is then elevated to 45° in a sling
to empty the supercial veins. e placement of cannulae
as described above, rather than by direct injection with
needle and syringe, allows the VV to be completely emptied of blood (so increasing the ecacy of the sclerosant)
and virtually excludes the risk of extravasation. Microfoam
aliquots (typically 2–3 mL, 1:4 gas-to-sclerosant ratio)
are then injected via the cannulae, usually moving from
proximal to distal. Typically, we use 3% STS for truncal
veins, 1% STS for major tributaries, and 0.5%–1% STS for
minor tributaries and supercial varices or very supercial truncal veins. e foam is injected slowly under direct
ultrasound visualization so that venospasm is maximized
and entry of foam into the deep system is minimized.7 For
larger truncal veins, we oen perform a second injection in
the proximal one or two truncal cannulae. e microfoam
can be “milked” along the VV and into tributaries and
Figure35.2 Schematic for great and small saphenous vein
cannulation. Note the directions of the cannulae (arrows).
varices using the ultrasound probe. Between injections,
the patient is asked to plantarex and dorsiex their ankle
to expel any foam that may have migrated into the deep
system. e quantity of foam used depends on the extent
of the veins to be treated, but in our practice, it would be
unusual to use more than 16 mL 3% 1:4 air microfoam,
which equates to 4 mL of 3% STS. ere is a range of views
as to whether it is necessary to perform manual compression of the saphenofemoral and saphenopopliteal junctions
(e.g., using direct pressure from the ultrasound probe) in
an attempt to prevent foam migration into the femoral and
popliteal veins.11 Having done this originally, the authors
discontinued the practice because it was felt to be ineffective and potentially counterproductive by potentially
allowing a sudden “bolus” of foam that has been trapped
within the GSV/SSV to enter the deep veins. is change
in practice has not been associated with any change in the
side-eect prole or ecacy of the treatment. Regarding
the treatment of perforators, the authors’ practice is not to
treat these directly, but rather to treat the supercial trunk
directly distal and proximal whilst applying digital pressure over the perforator to prevent foam spilling into the
distal deep venous system (asthe risk of causing a DVT
is probably greater than at the saphenofemoral junction
because the ows are slower and the diameters smaller).
However, others believe it is important to inject these perforators directly (under ultrasound guidance) with liquid
sclerosant. Once the trunk, tributary, and variceal veins
are observed on ultrasound to be in spasm and full of foam,
the cannulas are removed and, while the leg remains elevated, a cotton wool roll is placed over the trunk to provide
eccentric compression and the leg is wrapped in a cohesive,
non-elastic, conforming bandage. e patient is then tted
with a European class 2, thigh-length stocking. We recommend that this bandaging/stocking stays in place undisturbed for 3 days (5 days if larger VVs have been treated).
ereaer, the bandages are removed and the stocking
worn for a further 2–3 weeks. As is the case in many areas
of FS practice, there is a wide range of views regarding the
type and duration of post-procedure compression. Two
recent randomized controlled trials (RCTs) have reported
on this issue. One group compared bandaging for 24 hours
and 5 days, both followed by a thromboembolic-deterrent
stocking for the remainder of 2 weeks, and reported no
advantage of prolonged compression bandaging in terms
of phlebitis, skin discoloration, post-procedural pain,
improvement in health-related quality of life (HRQL), and
6-week target vein occlusion rates.
12
e other study compared compression stockings (15–20 mmHg) worn during
the day for 3 weeks with no compression and found no
dierence in occlusion rates, side eects (thrombophlebitis, inammation, pain, and pigmentation), satisfaction
scores, and HRQL.
13
e phlebologist now has a wide variety of endovenous techniques to treat VVs, and these can be combined
in imaginative ways so that the overall treatment oer is
424 Foam sclerotherapy for ablation of the saphenous veins, varicose tributaries, andperforating veins
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tailored to the individual patient’s needs, expectations, and
desires. We aim to completely eradicate all supercial reux
at a single FS treatment session, as staged treatment is less
convenient for the patient and less cost-eective. FS is particularly appropriate for complex recurrent disease associated with neovascularization, where the VVs to be treated
are oen too small, tortuous, and supercial to be treated
easily by means of endothermal ablation (ETA) and where
the versatility and adaptability of FS is a major advantage.
35.6 RESULTS OF FS
35.6.1 Observational case series
Numerous FS case series have been published. We have concentrated on the more recent papers, as FS techniques and
results have continued to improve. In 2010, we reported that
in a series of 344 legs with primary GSV reux, a single session of FS led to the abolition of reux in 95% of cases at
12 months.14 In 2014, we reported that in a cohort of 391
legs treated by means of FS, only 15% required further
treatment at a median follow-up of 71 months.15 In 2009,
Chapman-Smith and Browne reported a 4% clinical recurrence rate 5 years following FS and that 16.5% required
repeat FS at between 1 and 2 years.16 In 2012, a Taiwanese
group reported a 90% occlusion rate at 38 months following two sessions.17 With regard to recurrent VVs, we have
reported a 93% occlusion rate following a single FS treatment in 91 legs aected by recurrent GSV reux18 and a 91%
occlusion rate in 92 legs aected by recurrent SSV disease.19
With regard to bilateral disease, a study published in 2012
by Bhogal and colleagues showed no dierence in occlusion
rates or complications between synchronous and metachronous bilateral FS.20 However, as synchronous bilateral FS clearly requires a greater volume of microfoam to
be injected in a single session, it seems sensible to restrict
such treatment to patients with a limited burden of disease.
Several groups, including our own, have conrmed that,
when compared to conventional surgery (CS), FS is associated with quicker return to work and driving and with
lower pain/ analgesia requirements.
fore, numerous observational case series attest to the safety
and clinical ecacy ofFS.
21
In summary, there-
treatment for VVs that is well tolerated by patients.23 In a
RCT of 60 patients published in 2009, Figueiredo et al.
reported higher occlusion rates following FS (90%) than
aer CS (70%).24 In 2012, Shadid and coworkers reported
that in a large RCT, FS was not clinically inferior to CS at
2 years.25 A further six publications have reported on four
RCTs which have compared FS with ETA.
26 –31
Although
long-term occlusion rates following FS were lower, all of the
endovenous techniques studied led to highly signicant and
broadly similar improvements in patient-reported outcome
measures. Several trials have shown that FS is superior to
LS for the treatment of truncal VVs and venous malformations.
7,3 2
Devereux and coworkers reported that the use
of tumescence to reduce vein diameter prior to catheterdirected FS did not improve occlusion rates.33 e recently
published VANISH-2 trial suggests that at 12 months, the
results of treatment with Varithena are similar to those
seen aer FS using STS and PD “home-made” microfoam
in terms of symptoms, appearance, and occlusion rates on
duplex ultrasound.34 A summary of the major FS RCTs published since 2008 (the time of the last edition of the AVF
Handbook of Venous Disorders) is displayed in Table 35.1.
35.7 CONTRAINDICATIONS AND
SIDEEFFECTS
Contraindications to FS include:
●
Previous serious drug allergy to the sclerosant
●
Obstructed deep venous system
●
Coagulopathy
●
Peripheral arterial disease (ankle brachial pressure
index <0.8)
●
Pregnancy
Relative contraindications include:
●
Planned long-haul ight within 4–6 weeks—possible
increased risk of DVT
●
Patent foramen ovale—possible increased risk of systemic side eects
●
History of severe migraines—possible increased risk of
migraine
35.6.2 Randomized controlled trials
At the time this chapter was written, 17 RCTs have compared FS with CS, including phlebectomies, ETA using
laser or radiofrequency energy, and LS. Bountouroglou
and colleagues reported no dierences between FS with CS
aer 3 months.22 Kalodiki and coworkers also compared
FS and CS, and at 3 and 5 years, found similar improvements in venous clinical severity scores and HRQL (SF-36
and Aberdeen Varicose Vein Score) and suggested that FS
oered as a “dental care model” (treat as and when the
problem appears) is a clinically eective and cost-eective
e most common “side eects” of FS are lumpiness,
localized phlebitis, and skin staining in association with
excessive intraluminal thrombosis, which tends to occur
most oen within large and/or supercial VVs. ese
side eects can be mitigated by good technique, early
ultrasound-guided aspiration under local anesthetic, and
strong patient reassurance. Serious complications are
very rare following FS. For example, the French PD study
reported only eight (0.5%) muscular vein thromboses in
35
a series of 1605 patients treated with FS.
Similarly, in a
multicenter study of 1025 patients, Gillet et al. reported
only 10 (1%) patients (ve symptomatic) with DVT and one
35.7 Contraindications and sideeffects 425
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Table 35.1 Summary of major randomized controlled trials of foam sclerotherapy from 2008
Authors Sclerosant Trial arms Target vein Follow-up Conclusions
Brittenden
31
etal.
Devereux
33
etal.
Lattimer etal.
STS UGFS: 212
EVLA: 292
CS: 294
PD UGFS with tumescence:
25
UGFS without
tumescence: 25
29
STS UGFS: 50
EVLA: 50
GSV 6 months QoL improves similarly in
all treatments with
similar treatment efficacy
GSV 12 months No benefit of reducing
vein diameter with
tumescence analgesia
pre-treatment
GSV 3 + 12
months
UGFS less expensive with
comparable
effectiveness
Biemans etal.
30
PD UGFS: 80
EVLA: 80
CS: 80
GSV 12 months QoL improved significantly
with all treatments
EVLA and CS better than
UGFS according to
occlusion on US
Shadid etal.
25
STS UFGS: 230
CS: 200
GSV 2 years UGFS not inferior to CS
when examining reflux
associated with clinical
symptoms
Yamaki etal.
47
(2012)
Kalodiki etal.
PD UGFS: 51
Visual foam
sclerotherapy: 52
23
STS UGFS + SF ligation: 39
CS: 43
GSV 6 months UGFS and visual foam
sclerotherapy equally
effective
GSV 3 + 5 years Treatments equally
effective in VCSS and
HRQL scores
Liu etal.
(2011)
48
PD UGFS + SF ligation: 30
CS: 30
GSV 6 months UGFS + SF ligation
decreased treatment
time, post-operative
pain, and more rapid
recovery
Rasmussen
27
etal.
Ukritmanoroat
Blaise etal.
49
(2010)
Figueiredo
24
etal.
PD UGFS: 125
EVLA: 144
RFA: 148
CS: 125
32
PD 50 patients all treated
with LS and UGFS
PD UGFS 1% PD: 69
UGFS 3% PD: 70
PD UGFS: 27
CS: 29
GSV 1 + 3 years All treatments efficacious
with similar
improvements in VCSS
and QoL scores
All veins 90 days Foam more effective
thanLS
GSV 3 years 1% and 3% equivalent in
terms of efficacy
SSV + GSV 180 days UGFS is a safe and
effective option for
venous treatments
Abela etal.
50
(2008)
STS UGFS + SF ligation: 30
CS: 30
Invagination stripping: 30
GSV 2 weeks UGFS + SF ligation give
greater patient
satisfaction and less
post-operative pain
Ouvry etal.
51
(2008)
Note: STS; sodium tetradecyl sulfate; PD: polidocanol; UGFS: ultrasound-guided foam sclerotherapy; LS: liquid sclerotherapy; EVLA: endo-
venous laser ablation; RFA: radiofrequency ablation; CS: conventional surgery; SF: saphenofemoral junction; GSV: great saphenous
vein; SSV: small saphenous vein; QoL: quality of life; VCSS: venous clinical severity score; HRQL: health-related quality of life;
US:ultrasound.
PD UGFS: 47
LS: 48
GSV 2 years Foam more effective
thanLS
426 Foam sclerotherapy for ablation of the saphenous veins, varicose tributaries, andperforating veins
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with a pulmonary embolism.36 Abbassi-Ghadi and Hafez
reported no DVTs and one PE in a series of 213 FS treatments.37 Visual disturbances comprising unilateral/bilateral blurred vision, double vision, and scotoma have been
reported in 0.09%–4.5% of patients undergoing FS38; the
cause is unknown, but may relate to the release of vasoconstrictor chemicals from the damaged endothelium
(PE).39 Other neurological symptoms are extremely rare. A
review of the literature of several studies and case reports
involving 10,819 patients identied 15 transient ischemic
attacks and 12 cerebrovascular accidents, with one fatality
(reported as a case report in 1951). Two patients had residual weakness upon discharge from hospital and 11 of 16
transient ischemic attacks/cerebrovascular accidents were
associated with a patent foramen ovale.40 Symptoms oen
occurred minutes to hours aer FS, and the longest was
delayed to 5 days. e cause of these neurological symptoms remains incompletely dened, but foam bubbles passing into the cerebral circulation may be relevant in at least
some cases.41 Release of vasoactive moieties such as endothelin may also play a role.42 Similar adverse events have
been reported aer CS and ETA procedures,
43,44
which
perhaps suggest that at least some are coincidental and
unrelated to the FS. Myocardial infarction has also been
reported and may be unrelated or possibly the result of
bubbles passing through a patent foramen ovale and into
the coronary circulation.45 Inadvertent intra-arterial injection has been reported 63 times in the literature and has
led to amputation in 31 cases.46 Overall, therefore, FS is an
extremely safe treatment for VVs. However, it is suggested
that patients are provided with written information on
serious and common adverse events as part of the informed
consent procedure prior to FS. Total foam volumes of up
to 16 mL/treatment session for STS and 10 mL/treatment
session for PD are licensed for use in European countries.
Varithena is licensed in the United States for volumes of up
to 15 mL/treatment session.
35.8 CONCLUSION
FS is a widely applicable and highly versatile clinically eective and cost-eective treatment for primary and recurrent
VVs that can be safely performed in an oce setting and
is extremely well-tolerated by patients. However, further
observational studies and RCTs are required to optimize
patient selection, FS technique, and follow-up.
Guidelines 4.7.0 of the American Venous Forum on foam sclerotherapy
Grade of recommendation
No. Guideline
4.7.1 We recommend foam sclerotherapy in the
treatment of truncal primary and recurrent
varicose veins. This is applicable to patients with
CEAP clinical grade C2–C6.
4.7.2 We recommend using ultrasound-guided foam
sclerotherapy over liquid sclerotherapy for the
treatment of truncal varicose veins.
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Techniques and results of the modern surgical
treatment of the incompetent saphenous vein
ANJAN TALUKDAR AND MICHAEL C. DALSING
36.1 Introduction 429
36.2 Pertinent anatomy 429
36.3 Indications for surgical procedures 430
36.4 Contraindications 431
36.5 Diagnosis 431
36.1 INTRODUCTION
A patient with an incompetent saphenous vein may be
asymptomatic from a clinical perspective. e patient may
have varicose veins of the lower extremities, dened as
subcutaneous veins 3 mm or more in diameter visualized
when the patient is standing.1 Alternatively, there may be
non-specic early signs of chronic venous disease or more
advanced symptoms, such as severe edema or venous ulceration (clinical class C0–C6).
In the United States, about 23% of the adult population
has varicose veins and 6% have advanced chronic venous
disease, including skin changes and ulcerations. Based on
the San Diego epidemiologic study, about 11 million men
and 22 million women between the ages of 40 and 80 years
have varicose veins, and 2 million adults have advanced
disease.
nding or be associated with perforator and/or deep
venous disease either of an occlusive or insucient nature.
Fortunately, widespread use of venous duplex scanning has
aided in determining the likely reason(s) for the varicosities noted.3 e CEAP clinical classication of C0 to C6 was
29%, 23%, 10%, 9%, 1.5%, and 0.5%, respectively, in the
National Venous Screening Program which screened 2234
Americans. Reux or obstruction was seen in 37% and 5%
of participants, respectively.
ability, and deterioration of health-related quality of life.5
e annual medical cost of chronic venous disease in the
2
e incompetent saphenous vein may be an isolated
4
Varicose veins can be a cause of loss of working days, dis-
36.6 Techniques 432
36.7 Complications 436
36.8 Results 437
36.9 Conclusions 437
References 438
United States has been estimated to be between $150 million
and $1 billion.
5,6
36.2 PERTINENT ANATOMY
e variability of lower extremity venous anatomy does add
complexity to the operation, and has been discussed in prior
chapters of this text, with illustrations. Some review of pertinent points for the open surgery is useful.
Two of the most important anatomic structures involved
with open saphenous surgery would be the saphenofemoral
junction (SFJ) and saphenopopliteal junction (SPJ), which
have been retained in the current nomenclature of veins of
the lower extremity.7 It has been claried that the proximal level of each junction corresponds to the valve located
proximal to the saphenous opening (suprasaphenic valve)
and the valve located about 3–5 cm distal to the saphenous
opening.
e branches joining the great saphenous vein (GSV) at
the conuence of the inguinal veins are the anterior accessory GSV, the external pudendal vein, the supercial circumex iliac vein, and the supercial epigastric vein, as can the
posterior accessory GSV (although it can join lower in the
medial thigh), in addition to the posterior and anterior thigh
circumex veins occasionally. One anatomic dissection study
found that there are at least four common variations to how
these veins join, with incidence rates of the most common
being 33%, 15%, 15%, and 13%, demonstrating how variability is actually the norm in this dissection.8 e supercial
external pudendal artery helps to mark the termination of the
429
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