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Original Article
Treatment of Varicose Veins by Foam Sclerotherapy: Two Clinical
Series
A. Cavezzi
1
, A. Frullini
2
, S. Ricci
3
and L. Tessari
4
1
S. Benedetto del Tronto (AP),
2
Florence,
3
Rome and
4
Trieste, Italy
ABSTRACT
Objective: To assess the efficacy and safety of
sclerotherapy of varicose veins (VV) with sclerosing
foam (SF) made using Tessari’s method (three-way tap
and two plastic syringes).
Design: Two multi-centre prospective clinical series
were documented (CS1 and CS2). In CS1, which ran
from March to December 2000, 177 patients (39 men,
138 women), mean age 56 years, were treated in three
centres for VV related to incompetence of saphenous
veins, recurrence, perforators or collaterals. Conven-
tional or duplex-guided sclerotherapy was performed
using SF made of purified sodium tetradecyl sulphate
(PSTS) 0.2–3% (Fibro-vein, STD Pharmaceuticals, UK)
and air. An average of 1.6 (SD 0.8) sessions per patient
were performed and 2.9 (SD 1.0) ml of SF (i.e. 0.6 ml of
PSTS) per session was employed. An elastic stocking
providing 20–30 or 30–40 mmHg compression was worn
by patients following treatment. All the patients were
reviewed (clinical examination and colour duplex
ultrasonography) at 1 month. Sixty-six patients had a
further follow-up 45–370 days after treatment. The 17
patients in CS2, a multi-centre study, were treated in
March and April 2001. An independent observer
assessed patients with major VV (CEAP and VV type
distribution similar to CS1) before and after the
treatment, and also observed the treatment, which was
carried out using the technique employed in CS1.
Results: In CS1 at 1 month follow-up there was: (A)
obliteration of the vessel or antegrade flow in 161 (91%)
patients, (B) minimal retrograde flow in the treated vein,
without visible VV, in 15 (8.4%) cases and (C)
persistence of vessel patency with retrograde flow and
visible VV (failure) in 1 (0.6%) case. At 45–370 days
(mean 138 days) follow-up results were: type A in 44
(67%) cases, type B in 17 (26%) cases and type C in 5
(8%) cases. The main complications were extension of
sclerothrombus from superficial to deep veins (n= 2),
allergy (n= 1), malaise (n= 1) and scotoma (n= 1). In
CS2 at 30 days follow-up 100% of the treated venous
segments had a type A outcome after an average of 1.4
sessions. No relevant complication occurred in this
series.
Conclusions: Sclerotherapy of major VV by means of
SF prepared by Tessari’s method is a safe and effective
form of treatment. Low doses and a low concentration of
drug may be successfully employed. Further studies are
needed to establish the long-term results and overall
safety of this form of foam sclerotherapy.
Keywords: Sclerosing foam; Sclerotherapy; Ultrasound
imaging; Varicose veins
Introduction
Sclerotherapy of varicose veins (VV) has advanced
recently due to the introduction and development of
sclerosing foam (SF). Orbach was the first to describe
the use of a froth in sclerotherapy [1]. In 1995 new
methods of transforming the sclerosing liquid into a
foam were described by Cabrera et al. [2] and Monfreux
[3]. In 1997 Henriet [4] reported his experience with
Monfreux’s technique (which transforms the sclerosing
drug into a stable, large-bubble foam) for minor
varicosities, while Cavezzi and Frullini [5] in 1999
reported their 13 month experience of duplex-guided
Phlebology (2002) 17:13–18
ß2002 The Venous Forum of the Royal Society
of Medicine and Societas Phlebologica Scandinavica
PHLEBOLOGY
Correspondence and offprint requests to: Dr Attilio Cavezzi, Via
Miramare 7, I-63039 San Benedetto del Tronto (AP), Italy. Tel/fax:
+39 0735 83129. E-mail: cavezzia@insinet.it
sclerotherapy (DGS) with SF prepared by Monfreux’s
method. In 1998 Sadoun and Benigni [6] and in 1999
Garcia-Mingo [7] suggested new ways of manufacturing
SF. In December 1999 Tessari [8] described a safe, easy
method of producing a fairly stable and compact foam
(made of micro-bubbles of detergent drug and air) using
two plastic syringes and a three-way tap. Subsequently
Frullini [9] and Gachet [10] suggested other ways to
produce SF.
The foamy form of the detergent sclerosing drugs
purified sodium tetradecyl sulphate (PSTS) and polido-
canol (POL) has resulted in improvements in the efficacy
of sclerotherapy. Foam sclerotherapy reduces the dose
and concentration of injected drug [4,5]. DGS allows
visualisation of the sclerosant and considerable control
over which varices are treated. SF may be classified as
froth, macro-mini-bubble foam and micro-bubble foam.
The smaller the bubble size the greater the active surface
of the drug. It is generally recognised that the sclerosing
effect depends on the concentration of the drug within
the vein, and not the concentration in the syringe. There
is probably a ‘minimum effective concentration’ and the
exposure time is a further important variable. Foam
displaces blood from the vein, increasing the effective
concentration of the sclerosant and exposure time of the
vein to the drug allowing a lower concentration to be
used [11].
Analysis of the different methods of making SF has
revealed the advantages and disadvantages of each
technique. Cabrera et al.’s method of preparing foam is
under development for possible furture commercialisa-
tion; the details of this method have never been published
though the results of treatment look promising [12,13].
Tessari introduced a method to produce a fairly stable
SF by means of a three-way tap and two plastic,
disposable syringes, which results in a dense foam (Figs
1, 2). The authors have prepared PSTS foam using this
method for the last 2 years and in our hands it has given
very promising results, avoiding a few of the dis-
advantages of alternative techniques. The limited
durability of this kind of foam (significant coalescence
starts after the first 2–3 min) is resolved by reforming the
foam using the residual sclerosant.
The main features of this method were established in a
pilot study [14–16] which investigated how best to
produce and maintain SF. This pilot study analysed a
number of variables in the method of foam production,
as well its basic safety and efficacy.
Subsequently, the authors have completed two multi-
centre clinical studies, which are reported here, in order to
evaluate the immediate, short-term and medium-term
outcomes after sclerotherapy of truncal VV with SF
formed with PSTS according to Tessari’s method. The
clinical appearance of the limbs and the haemodynamic
results were assessed by means of physical examination
and colour-flow fuplex imaging (CFDI). We also assessed
the local and systemic complications of treatment.
Patients and Methods
Two multi-centre prospective clinical series were
recorded (CS1 and CS2). The studies were performed
in three different centres (private offices or clinics) by
the authors and only truncal VV were included for the
treatment (not minor varicosities). In the second study
(CS2) an external independent oberver (S.R., an expert
in varicose vein surgery) assessed the protocol. The first
clinical series (CS1) was carried out between March and
December 2000; 177 patients (39 men, 138 women),
mean age 55 years, were treated for their VV in one
limb. Only truncal varicosities were included and no
reticular veins or telangiectases were treated. Exclusion
criteria were: known allergy to PSTS, deep venous
thrombosis within the previous year, immobility, severe
general diseases (cardiac or renal failure, etc.),
pregnancy, puerperium or thrombophilic state.
All patients underwent clinical examination and CFDI
evaluation prior to treatment in order to record an
anatomical and haemodynamic map of the veins to be
treated. The diameter of the long saphenous vein (LSV),
anterior accessory saphenous vein (AASV) and short
saphenous vein (SSV) was measured 3 cm below the
junction. Table 1 summarises vein type and diameter as
well as the CEAP clinical class.
Fig. 1. Foam formation by means of Tessari’s method (three-way tap
and two disposable syringes).
Fig. 2. The resulting sclerosing foam.
14 A. Cavezzi et al.
PSTS (Fibro-vein, STD Pharmaceuticals, UK) was
used for all treatment. The concentration of PSTS was
determined according to the type and extent of VV. Each
author decided on the correct strength to use according
to his experience. This resulted in a wide range of
concentrations (from 0.2% for collaterals to 3% for
larger veins), which are reported in Table 2. In the
majority of cases 1% PSTS was used for saphenous
veins and recurrences. SF was formed by mixing 1 part
of PSTS and 4 or 5 parts of air, through 20 passages
between two disposable syringes and a three-way tap
(stop-cock) which had 308rotation of the hub, in order to
narrow the aperture through which the foam passed. The
method of foam formation was standardised amongst the
authors, according to the features reported in the pilot
study [16]. Before CS1 and CS2 were embarked upon,
Dr Di Stefano and Dr Minnocci from Pisa University
were asked to examine PSTS foam produced by the
Tessari method by electron microscopy. These observa-
tions confirmed the bubble size of PSTS foam produced
by this method to be less than 100 mm. Finally the three
authors had a pre-study meeting in order to standardise
the method of foam formation.
Duplex-guided sclerotherapy (DGS) was the preferred
method of treating saphenous stems or recurrences.
Conventional sclerotherapy was performed for collat-
erals. All the patients were treated in the supine position,
and vein canulation was performed under transverse or
longitudinal duplex scanning (DGS). Conventional
sclerotherapy was used to treat clinically apparent
varices. The injections were made through a ‘close
needle’ technique; no catheter or butterfly was used. The
foam was left free to fill the veins in CS1, while in CS2
sometimes foam was moved using the duplex probe to
the site at which it was required, e.g. towards the
saphenous junction. Immediate spasm is usually seen
following injection of foam and this was assessed by
CFDI and it was divided in ‘type I’ (with more than 80%
reduction of the calibre), or ‘type II’ (0–79%).
Compression was used in all patients. Cotton or rubber
pads were applied to the skin at the injection site to
increase the local pressure. A stocking was then applied
to the limb over the pads. The strength of compression
used was either 20–30 or 30–40 mm Hg.
The end-point of each session was the spasm of the
segment which had been treated. The final goal of the
whole treatment was the obliteration of the vein with
disappearance of reflux. An average of 1.6 (SD 0.8)
sessions per patient were performed. The quantity of SF
per session varied according to the treatment plan,
averaging 2.9 ml (SD 1) of SF per session (see Table 2
for details). This SF dose corresponds to an average of
0.6 ml of PSTS per session.
Local and systemic complications were recorded for
each patient. All the patients were reviewed by clinical
examination and CFDI 1 months following completion
of treatment. In addition 66 of the 177 patients had a
follow-up of 45–370 days (mean value 138 days). Each
author remained responsible for treatment and follow-up
of his own patients.
The second clinical series (CS2) was completed in
March and April 2001. The methodology was identical
to that of CS1, except that an independent observer (IO),
external to the group of doctors treating the patients,
assessed the efficacy of treatment. Seventeen patients
(16 women, 1 man; average age 53 years) were treated
(one limb per patient) for their truncal VV. All the
patients were evaluated before and after the treatment by
the IO, by means of clinical examination and CFDI
evaluation. CEAP and VV distribution was similar to
that of CS1, and is reported in Table 3. All treatments
were performed in the presence of the IO. An average of
1.4 sessions per limb were performed and an average of
3.2 ml of SF per session was used (i.e. 0.63 ml of PSTS).
The maximum permissible concentration of PSTS was
Table 1. Clinical series 1: Vein and CEAP distribution, mean values
and standard deviation of the diameter of the different kinds of veins
Vein CEAP
n% Diameter C n%
Mean SD
Coll 70 40% 5.1 1.6 2 115 65%
Rec 14 8% 7.6 2.3 3 26 15%
Aasv 8 5% 7.1 2.5 4 28 16%
Lsv 37 21% 7.5 2.7 5 7 4%
Ssv 31 18% 6.6 1.7 6 1 1%
Perf 17 10% 7.0 1.8
Total 177 6.3 2.2 Total 177
PSTS, purified sodium tetradecylsulphate; Coll, collaterals; Rec, groin
or popliteal recurrence; Lsv, long saphenous vein; Ssv, short
saphenous vein; Aasv, accessory anterior saphenous vein.
Table 2. Clinical series 1: PSTS concentration and doses according to the type of vein. Foam was made of 1 part of PSTS and 4 or 5 parts of air
PSTS concentration PSTS foam doses
Rec Coll Perf Aasv Ssv Lsv Total Rec Coll Perf Aasv Ssv Lsv Total
0.2–0.5% 1 46 2 3 2 7 61 42ml 42230 9745
0.6–1% 4 19 9 4 16 12 64 2.5–3 ml 6 39 9 4 16 20 94
>1% 9561131852 >3ml 4954 61038
Total 14 70 17 8 31 37 177 Total 14 70 17 8 31 37 177
Abbreviations as in Table 1.
Treatment of Varicose Veins by Foam Sclerotherapy 15
fixed at 1%, except for those LSV’s having a diameter
over 8 mm (see Table 4 for the related details). SF was
formed by mixing one part of sclerosant with 4 parts of
air and the maximum allowed dose of SF was 4 ml. The
method of limb compression was the same as in CS1.
Conventional sclerotherapy or DGS were administered
according to the vein type, as in CS1. Injections were
performed with the limb slightly raised (20 cm above the
couch level), in order to decrease vein diameter, thus
improving foam filling of the VV. The elevated limb was
maintained in this position for about 5 min after the last
injection, in order to allow the SF to be absorbed from
the superficial veins. In this study the authors used
duplex imaging following injection of foam by DGS or
conventional sclerotherapy, in order to monitor foam
movement and the early result. The resulting venous
spasm was evaluated as type I or II and any complication
was noted. All 17 patients were reviewed by the IO 30
days after completion of the treatment (end-point as in
CS1). The patients were interviewed by the IO
concerning their own judgement of the efficacy and
acceptability of the treatment.
In both series the outcome of the treatment was
classified according to the following criteria:
(A) Good, with obliteration of the vein or antegrade
flow within the treated vessel. Duplex imaging in
these cases revealed a sclerothrombus occupying
the whole treated venous segment or part of it
(partially occlusive thrombus). No reflux was
present.
(B) Moderate, with minimal retrograde flow within the
treated vessel, which was without visible varices.
Duplex showed partial sclerothrombosis of the vein
(partial compressibility).
(C) Failure, due to the persistence of vessel patency as a
whole or of a segment, with retrograde flow within
and visble VV.
Data are reported as the mean and standard deviation.
Statistical analysis of contingency tables was performed
using the chi-square test in order to assess significance of
the findings.
Results
Results of CS1 (the first clinical series) are detailed in
Table 5. In summary, CS1 outcomes at 1 month follow-
up when all 177 patients were assessed were of type A in
91% of cases. This fell to 67% of cases at the second
follow-up where 66 patients were reviewed. These
results show a 99% positive outcome as a whole
(obliteration of the treated vessels and/or VV disap-
pearance) at 30 days and 92% cumulative positive results
at the second follow-up. Post-treatment spasm was of
type I in 161 cases and of type II in 16. When examining
the mid-term (second follow-up for 66 patients) out-
comes, a type A result was documented in 71% of those
cases with type I spasm but only 29% positive (type A)
results in type II spasm.
Significant general and local complications were: 8
limited thrombophlebitis, 2 segmental extensions of the
sclerothrombus from SSV to deep vein (one of the two
was due to a technical mistake), 1 transient lymphoedema,
1 malaise, 1 scotoma, 1 small skin necrosis and 1 allergy.
The results of the second series (CS2) were similar to
the first. The main outcomes and the patients’ assess-
ments of their own treatment are summarised in Table 6.
Table 3. Clinical series 2: Vein and CEAP distribution, mean values
and standard deviation of the diameter of the different kinds of veins
Vein CEAP
n% Diameter n%
Mean SD
Rec 1 6% 7.0 0.0 2 7 41%
Coll 5 29% 6.2 2.4 3 5 29%
Aasv 3 18% 6.5 3.5 4 3 18%
Ssv 2 12% 5.5 0.7 5 2 12%
Lsv 6 35% 7.6 2.2
Total 17 6.7 2.2 Total 17
Abbreviations as in Table 1.
Table 4. Clinical series 2: PSTS foam concentration and doses according to the type of vein. Foam was made of one part of PSTS and 4 parts of
air
PSTS concentration PSTS foam doses
Rec Coll Perf Aasv Ssv Lsv Total Rec Coll Perf Aasv Ssv Lsv Total
0.2–0.5% 0 3 0 2 0 2 7 42ml 010010 2
0.6–1% 1 1 0 1 1 2 6 2.5–3 ml 1 2 0 0 1 4 8
>1% 010012 4 >3ml 120301 7
Total 1 5 0 32617 Total 2 5 0 3 2 5 17
Abbreviations as in Table 1.
Table 5. Clinical series 1: outcomes at 30 days and at second follow-
up
Results 30 days Second follow-up
A 161 91% 44 67%
B 15 8.4% 17 26%
C 1 0.6% 5 8%
16 A. Cavezzi et al.
One hundred per cent of the patients had a type I spasm,
and a positive result (type A, with disappearance of reflux
and VV disappearance) was achieved in 100% of the
cases at 30 days follow-up. No relevant complications
occurred. Table 6 also summarises the details of the
short-term outcomes according to the CFDI findings.
Patients’ overall satisfaction was very high, both in terms
of symptom relief and in terms of cosmetic appearance of
the limb.
In CS1 there was no significant relationship between
vein type, vein diameter, CEAP class and outcome after
30 days follow-up.
Table 7 shows that the larger- diameter veins (i.e.
diameter over 7 mm) negatively influenced the outcome
at the second follow-up in comparison with results at 30
days (p= 0.076). Moreover, limbs with complicated VV,
such as CEAP C3–C6, had a slightly worse result at the
second follow-up compared with limbs with CEAP C2.
Discussion
Sclerotherapy is influenced by several variables and it is
still considered a controversial modality of VV
treatment, probably with a higher recurrence rate than
surgery. An international consensus conference [17] has
shown a wide range of different practices in sclerother-
apy, demonstrating a lack of uniformity in performing
this treatment. A number of differences between the
techniques of the three authors of this paper emerged
during the collection of the first clinical series. During
CS2 the treatments were standardised as far as possible.
A few technical details were improved following CS1,
such as the introduction of the elevation and immobilisa-
tion of the treated limb, reflecting our increased
understanding of the new technique. Foam sclerotherapy
represents an advance of VV treatment and our initial
experience highlights the efficacy of SF prepared by
Tessari’s method using PSTS.
Two factors may explain the good results reported
here with foam sclerotherapy. Firstly the SF displaces
blood contained within the vein, with very little drug
dilution in the blood, for at least the first few minutes.
Secondly the active surface of the drug is greatly
increased by preparation of the foam.
DGS with SF is technically easier since SF is highly
echogenic on ultrasound imaging. SF is easily managed
and extravasation of SF is less harmful than pure liquid
extravasation. We recorded a high spasm and sclerosing
effect in the treated veins, and rapid achievement of the
end-points. We have used very low doses of the
sclerosing drug at a low concentration and these have
been sufficient to achieve the final positive results.
Our experience of this method of treatment during the
last 5 years [18–20] suggests some negative aspects of
SF. Extra time is required for the patient to lie supine
following the last injection. Deep vein thrombosis may
be provoked more easily with SF, due to technical
mistakes such as injections given too near deep veins or
an excessive amount of SF injected and chemical and
physical proprieties of foam. Neurological symptoms
have been reported by the present authors and by others
using SF. These require further study and necessitate
careful management of SF with limitation of the total
injected volume of sclerosant. Sclero-resistance as well
recurrence and recanalisation in the treated vessels still
persist. Sclerotherapy and surgery may be complemen-
tary treatments adequate to manage superficial venous
insufficiency of the lower limbs. However, a few major
differences between the two methods surely exist.
Sclerotherapy may result in a higher recurrence rate
due to recanalisation of the treated veins in the long
term. This may be more of problem with large size
saphenous trunks. Our results show that at longer follow-
up rather more signs of recurrence are seen, in keeping
with other reports on this subject. SF achieves the same
or better results as liquid sclerotherapy, using much
lower doses and concentrations of drug [21–23].
Complications and side effects compare favourably
with other reports on this subject.
Duplex assessment of sclerotherapy outcomes has
opened a window on the evolution of the treated vein
during follow-up [24,25]. Recanalisation of saphenous
stems following treatment does not always mean the re-
appearance of VV or of symptoms. This may be because
tributaries often remain sclerosed, perhaps preventing
saphenous reflux. Re-entry of saphenous retrograde flow
Table 6. Clinical series 2: Spasm occurrence and outcomes at 30 days
Results and spasm
Spasm type I 17 100%
Result type A 17 100%
Table 7. Clinical series 1: Analysis of type A results as to the main vein variables
Results type ‘A’ as to CEAP Results type ‘A’ as to diameter Results type ‘A’ as to vein
CEAP 30 days FU % Diameter (mm) 30 days FU % Vein 30 days FU %
2 34 27 79% <5 10 9 90% Coll, Perf 30 24 80%
3–6 23 17 74% <5–7 33 25 76% Lsv, Ssv, Aasv 27 20 74%
>7 14 10 71%
Coll, collaterals; Perf, perforators; Lsv, long saphenous vein; Ssv, short saphenous vein; Aasv, accessory anterior saphenous vein; FU, follow-
up.
Treatment of Varicose Veins by Foam Sclerotherapy 17
into deep veins may occur directly along saphenous
stems, without passing through tributaries. Fibrotic vein
walls resist turbulence better, thus varicose degeneration
of the treated veins is prevented. Sclerotherapy usually
reduces the diameter and haemodynamic load in treated
vessels, reducing venous compliance.
The absence of a life-long cure for varicose disease of
the lower limbs necessitates re-treatment when varices
recur. Part of the philosophy of the sclerotherapy
approach is that retreatment is an integral part of this
method. Foam sclerotherapy using Tessari’s method
incurs little expense for consumable items; the material
for a single session, drug included, costs as little as 10–
12 euros.
Foam sclerotherapy is undergoing further improve-
ments and a reappraisal of general sclerotherapy
managment is probably necessary. SF could possibly
replace liquid sclerosants for larger veins, increasing the
efficacy of DGS. Larger quantities of SF could be
employed than we have recorded above [26], possibly
achieving better results. In our most recent experience
we have injected larger quantities of SF (up to 6 ml).
This strategy may reduce the number of sessions
required to complete the treatment of all veins whilst
still maintaining safety. Our experience suggests that in
SSV treatment less than 3 ml of SF per session should be
used. Other types of foam may require different
technical procedures, but no data are available at the
moment to allow recommendations to be made.
The treatment of reticular varices and spider veins
using SF requires great caution as SF seems too powerful
even at low concentrations.
Larger groups of patients with extended follow-up are
necessary for a better elucidation of the proprieties of
Tessari’s method in foam sclerotherapy. Our first
experiences have demonstrated that sclerotherapy of
major VV by means of PSTS SF formed according to
this method is a safe and very effective form of
treatment. The ease and cheapness of this method
should ensure its widespread use, though some technical
aspects of the treatment mean that the outcome may be
operator dependent.
Acknowledgements. We thank STD Pharmaceuticals for providing the
authors with a grant related to the two studies. The authors are
sincerely grateful to Mr Emanuele Lanni for his help in the statistical
analysis.
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