sclerotherapy
TRANSCRIPT
Patients and methods
Foam polidocanol sclerotherapy versus liquid
polidocanol sclerotherapy in management of varicose
veins in lower limbs
AbstractBackground: Varicose veins treatment with liquid sclerosing drugs has been performed for almost 100 years.
The first foam sclerosant were described 60 years ago (Goldman et al, 2002). On contact of the sclerosant with the
vein endothelium, the treated veins will be transformed into fibrous cords that cannot recanalize with a functional
result corresponds to the surgical removal of varicose veins (Malouf, 2000).
Patients and methods: One hundred patients complaining of varicose vein lower limbs less than 4mm in
diameter with competent sapheno-femoral and sapheno-popliteal junctions undergone sclerotherapy; 50 patients
were injected by liquid polidocanol And 50 patients were injected by foam polidocanol in the outpatient Clinic of
Suez Canal University Hospital at Ismailia-Egypt. We followed our patients for 6 months in which they were
evaluated for disappearance of varicose veins, side effects and satisfaction with chosen regimen.
Results: Most of the studied patients in both groups were females (56% in foamy POL group and 64% in liquid
POL group). Most of the studied patients were in age group ranging from 30 – 50 years (76% in foamy POL group
and 80% in liquid POL group). Both groups were matched as regarding age and sex. After 4 weeks of
sclerotherapy, total disappearance was more evident among patients treated with the foamy form of POL (84%
versus 52% in liquid POL group). Resolution and fading in pigmentation was significant in both groups, however
it was significantly better with the use of foam group. Post-sclerosis pain was significantly more with the use of
Liquid form of POL with median visual analogue scale 3 versus 1 with the use of Foamy form of POL. There was
no statistically significant difference between both groups regarding the incidence of different side effects.
Discussion and conclusion: Improvement occurred with the use of foamy form of POL was significantly better
than what was recorded with the use of liquid form of POL.
Key words: Foam POL, Liquid POL, Sclerotherapy.
Introduction
Varicose veins treatment with liquid sclerosing drugs has been performed
for almost 100 years. The first foam sclerosant was described 60 years
ago, and was demonstrated that it is hard to tell who has really invented
the technique. However, it remains obvious that two authors –Cabrera in
Spain and Monfreux in France- have boosted its use in the past 10 years
(Goldman et al., 2002).
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Patients and methods
The aim of sclerotherapy is the elimination of intracutaneous,
subcutaneous, and/or transfascial varicose veins (perforating veins). The
contact of the sclerosant with the endothelium leads to changes in the
venous wall. In the long term, successfully treated veins will be
transformed into fibrous cords that cannot recanalize. The functional
result corresponds to the surgical removal of varicose veins (Malouf,
2000).
The first advantage of foam is that it does not mix much with blood,
and, therefore, mechanisms of dilution do not happen. Foam sclerosant
also offer the advantage of being an excellent contrast medium for B-
mode echography since ultrasounds are scattered by the multiple
air/liquid interfaces and foam is recognized by its white cloud aspect and
dark shade cone (Guex, 2005).
Many different types of foams have been used and presented, using
different sclerosing agents. The approved technique is a double-syringe
system technique which has been manufactured and standardized but is
still undergoing complete evaluation. The method of this technique is to
mix gas and liquid through either a three-way stopcock or double-syringe
system technique (Guex, 2005).
The ideal sclerosing solution should be painless to inject, free of
adverse effects, and specific for damaged (varicose) veins. The two most
widely used sclerosing solutions worldwide are sodium tetradecyl sulfate
(STS) and polidocanol (POL). These sclerosing agents have a well-
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Patients and methods
documented history of safety and efficacy spanning 40 to 50 years (Breu
et al., 2004).
Patients and methods
The study is a clinical comparative study between foam polidocanol
sclerotherapy versus liquid polidocanol sclerotherapy in management of
varicose veins in lower limbs.
It included one hundred patients undergone sclerotherpy; 50 patients were
injected by liquid polidocanol And 50 patients were injected by foam
polidocanol in the outpatient Clinic of Suez Canal University Hospital in
Ismailia-Egypt. We followed our patients for 6 months, in the first 2
months at two weeks interval and after that every month.
In our study, we included:
1. Patient with Varicose veins who were proved by duplex ultrasound to have varicose veins with competent sapheno-femoral and sapheno-popliteal junction.
2. Varicose veins that less than 4 mm in diameter.3. Both sexes4. Age range from 18 to 60 years.
We assessed our patients before the procedure by: Full history taking,
thorough clinical examination, duplex Ultrasound and pelvi-abdominal
ultrasound.
Data collection
A total of 100 patients were enrolled in the study and were randomly allocated to one of two groups: Foamy POL group and liquid POL group. Sample size was taken as all patients with varicose veins in any age, both sexes, varicose vein diameter less than 4 mm without
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Patients and methods
incompetence in the sapheno-femoral and sapheno-popliteal junctions in a leg with healthy skin including the sites of injection without any contraindication for sclerotherapy. Fifty Patients were injected in the outpatient clinic by liquid polidocanol sclerotherapy 0.5% and 1% concentration and the other group (50 patients) was injected by foam polidocanol sclerotherapy 0.5% and 1% concentration. The optimal concentration was determined
according to the diameter of vein .
Data management
Gathered data were processed using SPSS version 15 (SPSS Inc.,
Chicago, IL, USA). Quantitative data were expressed as means ± SD
while qualitative data were expressed as numbers and percentages (%).
Chi Square and Fisher's exact tests were used to test significance of
difference for qualitative variables. A probability value (p-value) < 0.05
was considered statistically significant.
Method of injection and preparation of Sclerotherapy :
1. Selection of the concentration and formulation (liquid or Foam) of
Sclerosing agent was based on protocol outlined and presented in
Table (1). The vein diameter was measured by duplex ultrasound,
while the patient is standing. If foam was necessary, it is
formulated from 1 ml of sclerosing solution and 4ml of air mixed
at ratio of 1:4, using The Tessari method which uses a three-way
stopcock and two 5 ml syringe to mix sclerosant. Appropriate post
procedure care was being conducted, and patients will be asked to
keep a record of any adverse events resulting from treatment.
Sclerotherapy will be performed by standard technique on only one leg in
single treatment session. The dose of sclerotherapy is 2ml in each session.
All patients will require elastic stocking compress to the treated leg for 7
days following treatment, and ask the patient to walk directly after
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Patients and methods
injection. After having first leg treated, subjects returned 1week later for
treatment of contra lateral leg. Patient`s will be seen every 2 weeks
thereafter for follow-up.
Digital photographs were taken prior to treatment and at 4 weeks post-
treatment.
Table (1) Concentrations of polidocanol according to the diameter of
varicose vein and quantities used per injection
___________________________________________________________
Diameter Liquid Foam
___________________________________________________________
1-2mm 1% 0.5%
2.1-3mm 1.25% 0.65%
3.1-4mm 1.5% 0.75%
4.1-5mm 2% 1%
5.1-6mm 2.5% 1.25%
Volume per injection 0.5 ml 2 ml
Quantity (Polidocanol) per injection 0.5 ml 0.5 ml
___________________________________________________________
(Hamel-Desnos et al., 2003).
Ethical consideration
Written consents will be obtained from all patients before getting
them involved in this study.
The steps of the study; the aims , the potential benefits will be
discussed with each individual patient ,
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Patients and methods
Patient will be informed about any abnormal results of procedure
and tests performed and will be instructed and treated accordingly.
The patient has the right for withdrawal from the study at any time
with neither jeopardizing the right of the patient to be treated nor
affecting the relationship between the patient and the care provider.
Results
The aim of the present study was to assess the efficacy of polidocanol
(POL) in the foamy and liquid form in sclerotherapy of varicose veins of
the lower limb. A total of 100 patients with varicose veins were enrolled
in the study and were then randomly allocated to one of two treatment
groups; foam POL group (n= 50) and liquid POL group (n = 50). The
patients were evaluated for disappearance of varicose veins, side effects
and satisfaction with each of liquid and foamy form.
Table 1: - Patient characteristics among both groups of the study: -
Foamy POL(n=50)
Liquid POL(n=50)
Total(n=100)
p-value
Age (years)
20 – 8 (16%) 6 (12%) 14 (14%)
0.7 (NS)30 – 22 (44%) 18 (36%) 40 (40%)
40 – 16(32%) 20(40%) 36 (36%)
50 – 55 4 (8%) 6 (12%) 10 (10%)
SexMale 22 (44%) 18 (36%) 40 (40%)
0.8 (NS)Female 28 (56%) 32 (64%) 60 (60%)
NS: no statistically significant difference (p-value > 0.05).
Table (1): Shows that both groups were matched as regarding age and
sex. Most of the studied patients in both groups were females (56% in the
foamy POL group and 64% in the liquid POL group). Most of the studied
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44%
36%
66% 64%
0%
10%
20%
30%
40%
50%
60%
70%
% o
f p
atie
nts
Male Female
Foamy POL Liquid POL
16%
12%
44%
36%
32%
40%
8%
12%
0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
% o
f p
atie
nts
20 – 30 – 40 – 50 – 55
Foamy POL Liquid POL
Patients and methods
patients were in age group ranging from 30 – 50 years (76% in foamy
POL group and 80% in liquid POL group).
Graph 1: - Age distribution among both groups of the study: -
Graph 2: - Sex distribution among both groups of the study: -
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16%
48%
84%
52%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
% o
f p
atie
nts
Partial disappearance Total disappearance
Foamy POL Liquid POL
Patients and methods
Table 2: - Disappearance of varicose veins in both groups of the study: -
DisappearanceFoamy POL
(n=50)Liquid POL
(n=50)Total
(n=100)p-value
Partial disappearance 8 (16%) 24 (48%) 32 (32%)0.03*
Total disappearance 42 (84%) 26 (52%) 68 (68%)
*Statistically significant difference
Table (2): Shows that there was statistically significant difference
between both groups as regarding degree of disappearance of varicose
veins after 4 weeks of sclerotherapy. Total disappearance was more
evident among patients treated with the foamy form of POL (84% versus
52% in liquid POL group).
Graph 3: - Disappearance in both groups of the study: -
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Patients and methods
Table 3: - Percentage of pigmentation pre and post-sclerosis in both groups of the study: -
% of pigmentationFoamy POL
(n=50)Liquid POL
(n=50)p-value
Pre-sclerosis 75% 78% 0.6 (NS)
Post-sclerosis 14% 47% 0.001*
p-value 0.001* 0.01*
*Statistically significant difference (p-value < 0.05)NS: no statistically significant difference
Table (3): illustrates the change in the percentage of pigmentation
after 4 weeks of sclerotic therapy in both groups. Improvement in the
percentage of pigmentation was significant in both groups, however the
improvement occurred with the use of foamy form of POL was
significantly better than what was recorded with the use of liquid form of
POL.
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Patients and methods
Table 4: - Degree of post-sclerosis pain and use of analgesia: -
Post-sclerosis painFoamy POL
(n=50)Liquid POL
(n=50)Total
(n=100)p-value
VAS
No pain 24 (48%) 12(24%) 36 (36%)
0.03*Mild 26 (52%) 28 (56%) 54(54%)
Moderate 0 (0%) 10 (20%) 10(10%)
median (range) 2(0 - 2) 6 (0 – 4) 4 (0 – 4)
Use of analgesia 4 (8%) 8(16%) 12 (12%) 0.7 (NS)
*Statistically significant difference (p-value < 0.05)NS: no statistically significant difference
Table (4): Shows that post-sclerosis pain was significantly more with
the use of Liquid form of POL with median visual analogue scale 3
versus 1 with the use of Foamy form of POL. Use of post-sclerosis
analgesia was higher in Liquid POL group but with no statistically
significant difference.
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Patients and methods
Table 5: - Side effects distribution among both groups of the study: -
Side effectsFoamy POL
(n=50)Liquid POL
(n=50)Total
(n=100)p-value
Ecchymosis 21 (42%) 19 (38%) 40 (40%) 0.8 (NS)
Hyper pigmentation 10 (20%) 6 (12%) 16 (16%) 0.7 (NS)
Itching 10 (20%) 8 (16%) 18 (18%) 0.9 (NS)
Telangiectatic matting 4 (8%) 2 (4%) 6 (6%) 0.9 (NS)
Marked swelling 6 (12%) 2(4%) 8 (8%) 0.6 (NS)
Superficial thrombophlebitis
0 (0%) 0 (0%) 0 (0%) 1 (NS)
DVT 0 (0%) 0 (0%) 0 (0%) 1 (NS)
Pulmonary embolism 0 (0%) 0 (0%) 0 (0%) 1 (NS)
Stroke 0 (0%) 0 (0%) 0 (0%) 1 (NS)
Skin necrosis 0 (0%) 0 (0%) 0 (0%) 1 (NS)
Allergic Reaction 0 (0%) 0 (0%) 0 (0%) 1 (NS)
NS: no statistically significant difference
Table (5): Shows the reported side effects among patients in both
groups of the study. Ecchymosis was estimated to be the most common
reported side effect in patients of both groups (42% in foamy POL group
and 38% in liquid POL group). These minor side effects were estimated
to be more common among patients treated with foam POL form but with
no statistically significant difference. Other reported side effects were
hyper pigmentation, Itching, telangiectatic matting and marked swelling.
There was no statistically significant difference between both groups
regarding the incidence of different side effects.
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Patients and methods
Graph 4: - Side effects distribution among both groups of the study: -
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92%
80%
8%
20%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
% o
f p
atie
nts
Satisfied Unsatisfied
Foamy POL Liquid POL
Patients and methods
Table 6: - Patients' satisfaction among both groups of the study: -
Foamy POL(n50)
Liquid POL(n=50)
Total(n=100)
p-value
Satisfied 46 (92%) 43 (86%) 89 (89%)
0.5 (NS)Unsatisfied 4 (8%) 7 (14%) 11 (11%)
Total 50 50 100(100%)
NS: no statistically significant difference
As regarding, the patient satisfaction with the form used in the
treatment, there was no significant difference between both groups. Only
11 patients were unsatisfied by the treatment; four patients in the foam
group and 7 in the liquid groups.
Graph 5: - Patients' satisfaction among both groups of the study: -
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Patients and methods
Discussion
The present study was aiming to assess the efficacy of polidocanol
(POL) in the foamy form and the liquid form in sclerotherapy of varicose
veins of the lower limb. A total of 50 patients with varicose veins were
enrolled in the study and were then randomly allocated to one of two
treatment groups; foam POL group (n= 25) and liquid POL group (n =
25). The patients were evaluated for clearance of varicose veins, side
effects and satisfaction with each of liquid and foamy form.
Polidocanol was reported by Goldman et al., (1987), Sadick (1994),
Weiss (1994) and Noel (2004) as an effective safe sclerosing solution
with distinct advantages of being forgiving with extravasation and having
extremely low risk of allergic reaction. The incidence of post sclerosis
pigmentation and telangiectatic matting in different sclerosing solutions
including polidocanol with different concentration was conducted in a
study done by Weiss and Weiss (1990). They stated that these
complications were related to both vessel size and to sclerosing
concentration.
Polidocanol at concentrations of 0.25%, 0.5% and 1% was injected in
the dorsal rabbit ear model by Goldman et al., (1987). They reported that
POL at concentration of 0.5% and 1% produced histologic and clinical
vein disappearance, whereas POL at 0.25% concentration didn't produce
clinical vein resolution. In addition, they noted recanalization at the low
concentration of 0.25%. In the present study we used both 0.5% and 1%
concentrations
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Patients and methods
Numerous studies were performed to compare the effect of different
sclerosing agents in the management of telangiectasia and reticular veins.
They used polidocanol in different concentration in their comparison. In
1987 Carlin and Ratz used polidocanol 0.25% in liquid form on 20
patients. The patients were injected every 4 weeks until all vessels had
disappeared or for a maximum of six visits. They reported that 13 patients
had good to excellent disappearance of veins and two had poor results.
They stated that the level of overall improvement was good. However,
they believed that the concentration of polidocanol that they used may
have been too low, resulting in slower disappearance of the vessels.
Another study used polidocanol 0.25% was presented by Kern et al.,
(2004). They used POL in both forms either as liquid or foam. A single
sclerosing session was performed in each patient. They proved that
polidocanol concentration of 0.25% had a lower efficacy in clearing the
telangiectatic and reticular veins in either forms.
Polidocanol at a concentration of 0.5% was used by Sadick (1994) to
treat reticular veins of 2 – 3 mm in diameter in 20 patients. A single
sclerosing session was performed in each patient. He stated that
polidocanol at this concentration was successful in the treatment of
reticular vessels. In 2005, another study was presented by Rao et al.,
using polidocanol in both forms, foamed and liquid. Their study was
carried on twenty patients. They emphasized that POL in both forms was
found to be effective in causing the disappearance of veins in all size
categories. Ecchymosis and reversible hyperpigmentation being the most
common adverse events occurred. Of note, no skin necrosis, no
recanalization was observed in any patient treated either form. All
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Patients and methods
subjects tolerated POL very well and were pleased with their treatments.
Their study confirms that POL, in both liquid and foamy forms have
similar efficacy, tolerability and patient satisfaction.
The results of this study show that for the same concentration of
polidocanol, the efficacy of sclerotherapy with foam is greater than with
liquid, although risks of minor adverse effects such as pain,
inflammation, and skin pigmentation are also more frequent. Other
authors have published similar results when using duplex-guided
sclerotherapy (Hamel-Desnos et al., 2003; Yamaki et al., 2004).
The specific characteristics of foam sclerosants may explain their
greater capacity and irritant nature. Foam sclerosants are compact
solutions that displace the blood column rather than dissolving in the
circulating blood. Foam adheres better to the walls of the vein, a feature
that, together with the capacity to provoke spasm, allows greater contact
with the endothelium, conferring greater efficacy at lower concentrations
and lower total quantity of sclerosant (Frullini et al., 2002).
The durability of the foam sclerosant combined with a greater capacity
to penetrate collaterals results in sclerosis over a larger region. The foam
is highly echogenic which facilitates ultrasound guided sclerotherapy,
increasing the safety of sclerosis of saphenous axes (Cavezzi and
Frullini, 1999; Frullini et al., 2000).
The greater efficacy seen in the foam group confirms the advantages
of this type of sclerosis and confirmation of efficacy by Duplex
ultrasound added value to the study. From the practical point of view,
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Patients and methods
foam sclerosis involves cheap, readily available, and easy to use products
in daily practice, not unduly lengthening the medical process and
probably reducing the number of sessions needed to treat each patient
(Alos et al., 2006).
Regarding the safety of the treatment, Harkins and Harmon in 1934
and Richardson in 1937 demonstrated the safety of injecting animals
with small doses of endovenous air for short periods. Based on these
experiments, Henriet (1997) analyzed the passage of this air to the
circulation system under several conditions of extracorporeal circulation
or during echocardiograms using air, confirming the safety of the
procedure. These results are consistent with several later clinical studies
using foam produced by various techniques (Garcia, 2001; Cavezzi et
al., 2002) proving that small doses of air injected intravenously do not
produce major systemic changes and are well tolerated by patients. The
presentation of major complications (deep vein thrombosis or lung
thromboembolism) is unusual with this technique and is probably related
to the dose used and the sclerosis region, occurring considerably more
often with truncal saphenous sclerosis, incompetent perforator veins, and
when large doses of foam are used (Varcoe, 2001). None of these
complications occurred in our study or in similar studies, mainly due to
the type of veins treated (reticular and postoperative) and the low doses
and concentrations used.
The minor complications recorded (local inflammation and
hyperpigmentation), which in our study were very similar to the study
published by Benigni and Sadoun (1999), present widely divergent
percentages in the literature, attributable to several possible factors: the
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Patients and methods
method of foam production, as non-industrial methods do not produce a
completely standardized microfoam; and the relatively low
concentrations and quantities used in each session (higher concentrations
of sclerosant produce smaller size bubbles). The larger bubble size could
be directly related to the appearance of inflammation beyond the
endothelium, involving the whole venous wall and the perivenous tissue
with the consequent clinical signs and anti-aesthetic secondary effects
such as skin pigmentation (Breu and Guggenbichler, 2004).
However, there is a clear tendency towards the reduction of foam
concentrations in order to achieve better results and avoid the secondary
effects characteristic of this technique. The use of postsclerosis, elastic
compression for only 48 h could have been another possible influential
factor as longer term compression has been shown to be effective in
reducing inflammation and its consequences (Vin and Benigni, 2003).
Skin pigmentation can also be reduced by performing drainage micro-
thrombectomy on the thrombosis of the treated vein (Scultetus et al.,
2003).
Other minor complications that have been described in the literature
(dizziness and blurred vision) derive from the passing of air from the
foam to the circulation system, are related to the total quantity of injected
foam, and are prevented by the patient gradually sitting up and previous
elevation of the treated limb (Frullini et al., 2002).
No incident of this kind was recorded in our study due probably to the
low doses administrated to all patients. There was a significant relation
between presentation of pigmentation and the concentration of sclerosant
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Patients and methods
used. but the sample size was small and statistical power limited, so care
must be used in the interpretation of this result.
An important feature of the design of this study and one which made
the two groups more homogeneous and easier to compare, was use of the
two techniques simultaneously on the same patient, each of whom acted
as his/her own control. Assessment of the differences between the
procedures was thus, more valid and precise with regard to both efficacy
and complications as any possible confounding factors that depended on
the patients were automatically corrected and variability was greatly
reduced. Likewise, the use of the duplex ultrasound allowed for greater
accuracy and objectivity in determining the percentages of sclerosant for
each venous caliber and enabled accurate measurement of partial and
complete efficacy.
In conclusion, the results of this study demonstrate that foam
polidocanol has greater sclerosant efficacy compared to liquid
polidocanol in the treatment of telangiectatic varices not involving the
saphenofemoral junction. A larger percentage of total sclerosis as well as
the extent of the obliterated region was observed. Despite this, foam
sclerosant also showed a greater tendency to provoke inflammation and
consequently mild adverse effects including pain, signs of inflammation
and skin pigmentation.
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