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ORIGINAL ARTICLES

Sclerotherapy of Varicose Veins with Polidocanol Based on the


Guidelines of the German Society of Phlebology
EBERHARD RABE, MD, AND FELIZITAS PANNIER, MDy

BACKGROUND Sclerotherapy involves the injection of a sclerosing agent for the elimination of intra-
cutaneous, subcutaneous, and transfascial varicose veins.
OBJECTIVE To update guidelines for sclerotherapy of varicose veins.
METHODS The guidelines for sclerotherapy of varicose veins of the German Society of Phlebology were
updated and modified through a review of the available literature.
RESULTS Published clinical series and controlled clinical trials provide evidence to support the elimination of
intracutaneous and subcutaneous varicose veins using sclerotherapy. Allergic skin reactions occur occasionally
as allergic dermatitis, contact urticaria, or erythema. Anaphylaxis is rare. Transient migraine headaches present
more frequently in patients treated with foam sclerotherapy than liquid sclerotherapy.
CONCLUSION Sclerotherapy is the method of choice for the treatment of small-caliber varicose veins
(reticular varicose veins, spider veins). If performed properly, sclerotherapy is an efficient treatment
method with a low incidence of complications.
BioForm Medical provided financial support for formal formatting of this manuscript without any influence
over the content of the manuscript. The authors have previously participated in two scientific studies with
polidocanol (ESAF and EASI study) financed by Kreussler.

S clerotherapy involves the injection of a


sclerosing agent for the targeted elimination
of intracutaneous, subcutaneous, and transfascial
Indications

The guidelines for sclerotherapy of varicose veins of


the German Society of Phlebology were slightly
varicose veins (perforating veins) and the
modified and updated with the results from recently
sclerosation of subfascial veins in the case of venous
published data.3
malformation. Various sclerosants induce marked
damage of the vascular endothelium and possibly The objectives of sclerotherapy are:
of the entire vascular wall. After successful
sclerotherapy and in the long term, the veins are  Treatment of varicose veins and prevention of
transformed into a fibrous cord, a process known possible complications.
as sclerosis.1,2 The purpose of sclerotherapy is
not merely to achieve thrombosis of the vessel,  Reduction or elimination of existing symptoms.
which per se may be amenable to recanalization,  Improvement of pathologically altered venous
but definitive transformation into a fibrous cord. hemodynamics.
This cord cannot recanalize, and the functional
result is equivalent to the surgical removal of a  Achievement of good results that satisfy aesthetic
varicose vein. and functional criteria.

Department of Dermatology, University of Bonn, Bonn, Germany; and yDepartment of Dermatology, Maastricht
Universitary Medical Centre-MUMC+, Maastricht, The Netherlands

& 2010 by the American Society for Dermatologic Surgery, Inc.  Published by Wiley Periodicals, Inc. 
ISSN: 1076-0512  Dermatol Surg 2010;36:968–975  DOI: 10.1111/j.1524-4725.2010.01495.x

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TABLE 1. Indications for Sclerotherapy TABLE 2. Contraindications in Sclerotherapy


 Saphenous veins (great saphenous vein and small Absolute Relative
saphenous vein) contraindications contraindications
 Accessory saphenous veins
 Varicose veins associated with perforator Liquid and foam sclero- Liquid and foam sclero-
incompetence therapy: therapy:
 Reticular veins  Known allergy to  Leg edema, uncom-
 Telangiectases the sclerosant pensated
 Residual and recurrent varicose veins after  Severe systemic  Late complications
treatment disease of diabetes (e.g.,
 Pudendal and genital varicose veins  Acute deep vein polyneuropathy)
 Peri-ulcerous veins thrombosis  Arterial occlusive
 Venous malformations  Local infection in disease, Stage II
the area of sclero-  Poor general health
therapy or severe  Bronchial asthma
In principle, all types of varicose veins are amenable generalized infec-  Marked allergic
to sclerotherapy. Particular indications are listed in tion diathesis
 Lasting immobility  Known thrombophil-
Table 1. and confinement to ia or hypercoagulable
bed state with or without
Sclerotherapy is the method of choice for the treat-  Advanced periph- a history of deep vein
eral arterial occlu- thrombosis
ment of small-caliber varicose veins (reticular vari-
sive disease (Stage Foam sclerotherapy:
cose veins, spider veins). For the obliteration of III or IV)  Known asymptom-
accessory varicose veins and incompetent perforating  Pregnancy (unless a atic patent foramen
veins, sclerotherapy competes with percutaneous compelling medical ovale
reason exists)  High risk of throm-
phlebectomy and with ligation of perforating veins
Foam sclerotherapy: boembolic events
or endoscopic dissection of perforating veins.4,5 In  Known symptom-  Visual disturbances
the treatment of saphenous veins, surgery has been atic patent foramen or neurological
the method of choice, but treatment of truncal veins ovale disturbances after
previous foam
using sclerotherapy is also possible.6–8 This applies sclerotherapy
in particular to foam sclerotherapy, as studies
conducted in recent years have demonstrated.9–13
are extremely rare complications constituting an
emergency situation.18,19 Transient migraine-like
Contraindications symptoms occur more commonly after foam sclero-
therapy than after liquid sclerotherapy.14,17 In this
Absolute and relative contraindications are listed in context, it has been speculated that a patent foramen
Table 2.

TABLE 3. Possible Adverse Events in


Complications and Risks Sclerotherapy
 Allergic reaction
If performed properly, sclerotherapy is an efficient  Skin necroses
treatment method with a low incidence of compli-  Excessive sclerosing reaction
cations. In therapy, a number of adverse events may  Pigmentation
 Matting
be encountered. These are shown in Table 3.14–17  Nerve damage
 Scintillating scotomas
Allergic skin reactions occur occasionally as allergic  Migraine-like symptoms
 Orthostatic collapse
dermatitis, contact urticaria, or erythema. Anaphy-
 Thromboembolism
lactic shock and inadvertent intra-arterial injection

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ovale (PFO), which is present in approximately 25% disturbed sense of taste, feeling of tightness in the
of the population, might be a factor, allowing foam chest, pain at the injection site, swelling, induration,
bubbles to pass into the arterial circulation.18–22 mild cardiovascular reactions, and nausea.
Additionally, complications such as blister formation
Thromboembolic events [deep vein thrombosis (DVT), (blisters in the vicinity of an adhesive plaster) may
pulmonary embolism or stroke] occur in rare circum- arise because of the compressive bandage.4
stances after sclerotherapy. Most of these events, Intravascular clots can be squeezed out after a
diagnosed in routinely performed duplex investiga- stab incision to reduce the development of
tions, are asymptomatic.14,17 According to prospective hyperpigmentation.
studies, the risk of DVT is higher when larger volumes
of sclerosant are used, particularly in the form of
Diagnosis Before Sclerotherapy
foam9,23–25 and in patients with a previous history of
thromboembolism or known thrombophilia.26 In pa- To be successful, sclerotherapy requires thorough
tients with these risk factors, the indication for sclero- planning. Therefore, a proper diagnostic evaluation
therapy must be clearly established, and additional should be performed before treatment.3 Diagnostic
precautionary measures must be observed.27 Single evaluation includes history-taking, clinical examin-
case reports of proven stroke or transient ation, and Doppler ultrasound investigation. Func-
ischemic attack after liquid or foam sclerotherapy in tional examinations make it possible to assess
patients with PFO have been published.17,23,28,29 improvement in venous function, which is to be
Multiple small-dose injections of foam can reduce the expected for the elimination of varicosis. Diagnostic
passage of sclerosant foam into deep veins.30 imaging is especially suitable for identifying incom-
petent junctions with the deep venous system and for
Skin necroses have been described after perivascular locating pathologic reflux, as well as for clarifying
injection of sclerosants in higher concentrations and post-thrombotic changes and selecting the most
rarely after properly performed intravascular injection appropriate treatment option. In addition, sclero-
with sclerosants in various concentrations, for exam- therapy is an intervention that requires patients’
ple, with 0.5% polidocanol in the treatment of spider informed consent.
veins.31 In the latter case, a mechanism involving
passage of the sclerosant into the arterial circulation
Implementation of Sclerotherapy of Varicose
via arteriovenous anastomoses has been suggested.32
Veins Using Polidocanol
In individual cases, this has been described as embolia
cutis medicamentosa.33 Extensive necroses occur after Polidocanol in concentrations of 0.25%, 0.5%, 1%,
inadvertent intra-arterial injection.31,34 Instances of 2%, 3%, and 4% is licensed in Germany for
hyperpigmentation have been reported, with fre- sclerotherapy of varicose veins. The maximum daily
quencies ranging from 0.3% to 10%.15,35 In general, dose of polidocanol is 2 mg/kg of body weight.38
this phenomenon regresses slowly. The incidence of
pigmentation is likely to be higher after foam sclero-
Sclerotherapy with Sclerosing Solutions
therapy.14 Matting in the area of a sclerosed vein is an
(Liquid Sclerotherapy)
unpredictable individual reaction of the patient and
can also occur after surgical removal of a varicose Table 4 provides guide values for concentration and
vein.31 Local paresthesia after sclerotherapy is volume per injection for liquid sclerotherapy.38
rare.36,37
A smoothly functioning disposable or glass syringe
Other transitory phenomena after sclerotherapy and a small-diameter cannula are required for
include intravascular clots, phlebitis, hematomas, sclerotherapy. Cotton-wool rolls or pads and

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TABLE 4. Guide Values for Concentration and Vol- performed for hours up to several days and weeks
ume Per Injection of Polidocanol Used for Liquid after completion of sclerotherapy.
Sclerotherapy
 After a sclerotherapy session using the traditional
Volume Per In- Concentration technique, the patient should ambulate (physical
Indications jection, mL %
thromboprophylaxis). Careful watch must be kept
Spider veins 0.1–0.2 0.25–0.5 for any signs of allergic reactions.
Central veins of 0.1–0.2 0.25–1
spider veins  Intensive sports activity, hot baths, sauna, and
Reticular vari- 0.1–0.3 1
strong ultraviolet irradiation (solarium use) should
cose veins
Small varicose 0.1–0.3 1 be avoided in the initial days after sclerotherapy.
veins
Medium-size 0.5–2.0 2–3
varicose veins
Large varicose 1.0–2.0 3–4 Sclerotherapy with Foamed Sclerosants
veins (Foam Sclerotherapy)

The literature has long contained reports of sclero-


adhesive paper tapes are used for local compression. therapy with foamed sclerosants.39 In recent years,
The different techniques vary considerably. The fol- as the technology has improved, foam sclerotherapy
lowing principles apply to liquid sclerotherapy: has become established, particularly for the treat-
ment of larger varicose veins.40,41 Detergent-type
 Puncture of the veins can be performed with the sclerosants such as polidocanol can be transformed
patient standing or lying down. into fine-bubbled foam using special techniques.

 The injection is usually performed with the patient In the Monfreux technique,41 negative pressure is
in a supine position. After the vein has been generated by drawing back the plunger of a glass
punctured with the free injection needle or with the syringe, the tip of which is tightly closed. The
syringe attached, the intravascular position is resulting influx of air produces large-bubbled, fairly
checked. fluid foam.39 In the Tessari technique, the turbulent
 Intravascular injection of the sclerosant is per- mixture of liquid and air in two syringes connected
formed slowly and incrementally, checking that the using a three-way stopcock produces the foam. It is
cannula is positioned inside the vein. Severe pain fine-bubbled and fluid at low concentrations and
during injection may be indicative of perivascular rather viscous at high concentrations. The mixing
injection. ratio for sclerosant to air is 1:3 to 1:4. The double
syringe system technique involves the turbulent
 Immediately after injection of the sclerosant and mixing of polidocanol with air in a sclerosant to air
removal of the cannula, local compression is per- ratio of 1:4 in two syringes linked using a connector.
formed along the course of the sclerosed vein. The resulting product is fine-bubbled, viscous
foam.39
 After sclerotherapy, compression is applied to the
treated extremity. Compression can be performed
The standardized transformation of a licensed liquid
using a compression stocking and a compression
sclerosant into a foam sclerosant and treatment
bandage.
with it is permissible provided that the patient has
 Local compression can be removed the same eve- been adequately informed about the procedure and
ning or the next day. Depending on the diameter about the benefits and risks of the method and
and location of the varicose veins, compression is consents to its use. Even if foam is used off-label, the

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published evidence and data document the use as a TABLE 5. Preferred Foam Volume Per Venous
standard procedure. Puncture

Mean Foam Maximum Foam


The Second European Consensus Conference Volume Per Volume Per
on Foam Sclerotherapy took place at Tegernsee, Puncture, mL Puncture, mL
Germany in April 2006. On the basis of the expert’s
GSV 2–4 6
own experience and the available literature, the SSV 2–4 4
following recommendations on foam sclerotherapy Collateral Up to 4 6
were given, partially modified for the veins
Recurrent var- Up to 4 8
guideline.27 icose veins
Perforating Up to 2 4
veins
Puncture and Injection Reticular vari- o0.5 o1
cose veins
When treating the great saphenous vein (GSV) by Spider veins o0.5 o0.5
direct puncture, it is recommended that venous Venous mal- 2–6 o8
puncture be performed in the proximal thigh area. If formations
long catheters are used, it is recommended that
access to the GSV be made below the knee. When
treating the short saphenous vein (SSV) by direct foam sclerosant for all indications. A mixture of
puncture, it is recommended that venous puncture be carbon dioxide and oxygen may also be used. The
performed in the proximal or middle part of the preferred ratio of liquid sclerosant and gas for the
lower leg. When treating the perforating veins, it is generation of a foam sclerosant is 1:4 (1 part liquid
recommended that the injection not be made directly to 4 parts gas). Ratios between 1:1 and 1:5 are
into the affected vein. used for reticular varicose veins and spider veins, but
the majority use the 1:4 ratio. The preferred foam
volumes per venous puncture are shown in Table 5,
Foam Generation, Concentrations,
and the preferred concentrations are outlined in
and Volumes
Table 6. The recommended maximum foam volume
The Tessari and Tessari/double syringe system per leg and session (given in a single injection or
methods are recommended for the generation of in several injections) is 10 mL. When treating
foam sclerosant for all indications. Air is accepted or large-caliber varicose veins, the foam sclerosant
proposed as the gas component for the generation of should be as viscous as possible.

TABLE 6. Preferred Polidocanol Concentrations Per Indication

Liquid 0.25% 0.5% 1% 2% 3% 4%

Great saphenous vein 1 11 11


Small saphenous vein 1 11 1
Collateral veins 11
Recurrent varicose veins (1) 11 11 1
Perforating veins (1) 11 1 (1)
Reticular varicose veins (1) (1) 11 1
Spider veins 11 (1) (1)
Venous malformations 1 11 1

The stated concentrations refer to the liquid polidocanol solution from which foam is generated.
Foam sclerotherapy is not the treatment of choice for vessels smaller than 1 mm in diameter. For sclerotherapy of spider veins the
recommendation is first to use liquid polidocanol. When foam is used, small volumes of 0.25% foam are preferred.

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Safety Measures there is a risk of developing (transient) neurological


symptoms, there is a risk of developing (transient)
Safety during foam sclerotherapy of the GSV and
visual disturbances, and there is a risk of triggering
SSV can be improved by avoiding immediate com-
migraine.
pression of the injected areas, using ultrasound to
monitor foam distribution, injecting a highly viscous
As before liquid sclerotherapy, patients should be
foam, and ensuring that there is no patient or leg
informed about the expected treatment outcome. In
movement for 5 minutes and no Valsalva maneuver
addition, they should be told that short-term out-
or other muscle movement.
comes are highly satisfactory; further therapy is
possible and may be necessary in some cases, espe-
The known presence of a PFO indicates that
cially in treatment of large varicose veins; and foam
sclerotherapy must be performed with special pre-
sclerotherapy is more effective than liquid sclero-
caution. Such patients patient should remain lying
therapy.
down for longer (8 to 30 minutes), use only small
volumes of foam (2 mL) or liquid sclerotherapy, and
avoid Valsalva maneuvers. Efficacy

Numerous published clinical series and controlled


Before foam sclerotherapy, it is not considered nec-
clinical trials provide evidence to corroborate the
essary to perform specific investigations for PFO.
elimination of intracutaneous and subcutaneous
varicose veins using sclerotherapy.
A high risk of thromboembolism in the patient’s
history and known thrombophilia (especially in
In older studies with liquid sclerotherapy, surgery
combination with a high risk of thromboembolism)
was significantly more effective in the treatment of
indicates that sclerotherapy must be performed with
saphenous varices.4 In the treatment of saphenous
special precaution. It is recommended that, in such
varicose veins, foam sclerotherapy is significantly
patients, adequate low-molecular-weight heparin
more effective than liquid sclerotherapy.11,13,42–44
prophylaxis (in line with relevant guidelines and
The immediate occlusion rate of the GSV after foam
recommendations) be instituted, physical prophy-
sclerotherapy reaches 70% to 95%.9–13 After 1 to 3
laxis be implemented, low sclerosant concentrations
years of follow-up, the occlusion rate drops to 55%
be used for foam generation, and small volumes of
to 80%.9,11,12,45,46 The occlusion rate depends on
foam be used. The practitioner is advised to perform
the initial diameter of the vein and the injected foam
a benefit-risk assessment based on the particular
volume and concentration.13,25 Long catheter-
indication.
assisted foam sclerotherapy of the GSV, with or
without terminal balloon, seems to have slightly
It is not considered necessary to perform specific
better occlusion rates.47–51 Foam sclerotherapy is
investigations for thrombophilia before foam
also more effective in the treatment of venous
sclerotherapy.
malformations than liquid sclerotherapy.43 In the
treatment of accessory varicose veins, liquid sclero-
therapy is less effective than surgery.52 In contrast,
Patient Information
occlusion rates after foam sclerotherapy are better
Before foam sclerotherapy, patients should be than those in saphenous veins.53 The occlusion rate
informed about risks and possible adverse effects in after 3 years reaches 80%.53 In patients with venous
the same way as before liquid sclerotherapy. In ulcers, sclerotherapy of peri-ulcer varices improves
addition, they should be told that there is a slightly ulcer healing.54–56 Sclerotherapy is the standard
higher risk of hyperpigmentation and inflammation, treatment for intracutaneous varicose veins

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(telangiectases and reticular veins), allowing nol foam (ESAF): a randomised controlled multicentre clinical
trial. Eur J Endovasc Vasc Surg 2008;35:238–45.
improvement of up to 90% to be achieved.57–60
14. Guex JJ, Allaert F-A, Gillet J-L. Immediate and midterm com-
plications of sclerotherapy: report of a prospective multicenter
Compression treatment with medical compression registry of 12,173 sclerotherapy sessions. Dermatol Surg
stockings may improve the results of sclerotherapy 2005;31:123–8.

for spider veins.35,61 The incidence of pigmentation 15. Munavalli GS, Weiss RA. Complications of sclerotherapy. Semin
Cutan Med Surg 2007;26:22–8.
decreases significantly.35,62 Local eccentric com-
pression significantly increases local pressure in the 16. Weiss RA, Weiss MA. Incidence of side effects in the treatment of
telangiectasias by compression sclerotherapy: hypertonic saline vs.
sclerosed area and improves the efficacy of sclero- polidocanol. J Dermatol Surg Oncol 1990;16:800–4.
therapy.63 17. Gillet JL, Guedes JM, Guex JJ, et al. Side effects and complica-
tions of foam sclerotherapy of the great and small saphenous
veins: a controlled multicentre prospective study including 1025
patients. Phlebology 2009;24:131–8.

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