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11. Goldman MP , Kaplan RP , Oki LN . Sclerosing agents in the treat-
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ment of telangiectasia: Comparison of the clinical and histologic
e ects of intravascular polidocanol, sodium tetradecyl sulphate, and
hypertonic saline in the dorsal rabbit ear vein model , Arch Dermatol.
1987. 123 : 1196–1201.
12. Tessari L , Cavezzi A , Frullini A . Preliminary experience with a new
sclerosing foam in the treatment of varicose veins , Dermatol Surg.
2001. 27 : 58–60.
13. Cavezzi A , Tessari L . Foam sclerotherapy techniques: Di erent
gases and methods of preparation, catheter versus direct injection ,
Phlebology. 2009 . 24 : 247–251.
14. Myers KA , Jolley D , Clough A , Kirwan J . Outcome of
ultrasound-guided sclerotherapy for varicose veins: Medium-term
results assessed by ultrasound surveillance , Eur J Vasc Endovasc Surg.
2007 . 33 : 116–121.
15. Guex J-J . Indications for the sclerosing agent polidocanol , J Derm
Surg Onc. 1993. 19 : 959–961.
16. Kanter A . Clinical determinants of ultrasound-guided sclerotherapy:Part II:In search of the ideal injectate volume , Dermatol Surg.
1998. 24 : 136–140.
17. Biegeleisen K , Neilson RD , O’Shaughnessy A . Inadvertent
intra-arterial injection complicating ordinary and ultrasound-gu ided
sclerotherapy , J Derm Surg Onc. 1993. 19 : 953–958.
18. Grondin L , Soriano J . Duplex-echosclerotherapy, in the quest
for the safe technique. In: Raymond-Martimbeau P , Prescott R ,
Zummo M , eds. Phlebologie ’92 . Paris: John Libbey Eurotext . 1992.
828–833 .
19. Coleridge Smith P . Chronic venous disease treated by ultrasound guided
foam sclerotherapy , Eur J Vasc Endovasc Surg. 2006 . 32 : 577–583.
20. Parsi K . Extended long line echosclerotherapy , Sclerotherapy of
Australia Newsbulletin. 1997. 1 : 10–12.
21. Min RJ , Navarro L . Transcatheter duplex ultrasound-guided sclerotherapy for treatment of greater saphenous vein re ux:Preliminary
report , Dermatol Surg. 2000. 26 : 410–414.
22. Parsi K , Lim AC . Extended long line echosclerotherapy , ANZ J
Phleb. 2000. 4 : 6–10.
23. Somjen GM , Ziegenbein R , Johnston AH , Royle JP . Anatomical
examination of leg telangiectases with duplex scanning , J Dermatol
Surg. 1993. 19 : 940–945.
24. Forrestal MD . Evaluation and treatment of venulectatic and telangiectatic varicosities of the lower extremities with duplex ultrasound (DUS)-guided injection sclerotherapy, Dermatol Surg. 1997.
24 : 996–997.
25. Fegan WG . Continuous compression technique of injecting varicose
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26. ibault P . Internal compression (peri-venous compression) following ultrasound guided sclerotherapy to the great and small saphenous veins, ANZ J Phlebol. 2005 . 9 : 29.
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28. ibault PK . Sclerotherapy of varicose veins and telangiectasias: A2-year experience with sodium tetradecyl sulphate , ANZ J
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29. Chapman-Smith P , Browne A . Prospective ve-year study of
ultrasound-guided foam sclerotherapy in the treatment of great
saphenous vein re ux , Phlebology. 2009 . 24 : 183–188.
30. Cavezzi A , Frullini A . e role of sclerosing foam in ultrasoundguided
sclerotherapy of the saphenous veins and of recurrent varicose
veins:Our personal experience , ANZ J Phleb. 1999. 3 : 49–50.
31. Myers KA , Wood SR , Lee V . Early results for objective follow-up
by duplex ultrasound scanning a er echosclerotherapy or surgery for
varicose veins , ANZ J Phleb. 2000. 4 : 71–74.
32. Kanter A . Clinical determinants of ultrasound-guided sclerotherapy
outcome:Part1: e e ects of age, gender, and vein size , Dermatol
Surg. 1998. 24 : 131–135.
33. Barrett JM , Allen B , Ockleford A , Goldman MP . Micofoam
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34. ibault PK . “5year” follow-up of greater saphenous vein incompetence treated by ultrasound guided sclerotherapy , ANZ J Phleb.
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Phlebology . 2009 . 24 : 240–246.
36. Ouvry P , Allaert F-A , Desnos P , Hamel-Desnos C . E cacy of polidocanol foam versus liquid in sclerotherapy of the great saphenous
vein: Amulticentre randomised controlled trial with a two-year
follow-up, Eur J Vasc Endovasc Surg. 2008 . 36 : 366–370.
37. Rabe E , Otto J , Schliephake D , Pannier F . E cacy and safety of great
saphenous vein sclerotherapy using standardised polidocanol foam
(ESAF):Arandomised controlled multicentre clinical trial, Eur J
Vasc Endovasc Surg. 2008 . 35 : 238–245.
38. Padbury A , Benveniste GL . Foam echosclerotherapy of the small
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158 • PRIMARY SUPERFICIAL VENOUS INSUFFICIENCY
19.
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SCLEROFOAM FOR TREATMENT OF VARICOSEVEINS
J e a n - J é r ô m e G u e x
HISTORY AND BACKGROUND
Sclerofoam is not a new idea. Many authors presented their
1
own recipes, and sometimes results, decades ago.
However,
sclerofoam became more popular a er Cabrera (in Spain)
and Monfreux (in France) presented their results in the
2,3
late 1990s.
A er a period of reluctant observation, many
surgeons previously unaccustomed to foam sclerotherapy
began to express unexpected interest because it “worked
amazinglywell.”
At that time, “evidence-based medicine” had expanded
its in uence over the world, and had even penetrated
phlebology. e time had come for a true evaluation. e
problem was the usual one in trying to apply the rules of
evidence-based medicine: sclerofoam worked so well that
nobody wanted to waste time to demonstrate what was
obvious.
Another obstacle to testing foam sclerotherapy was the
demonstration of e cacy presented by endovenous ablation, the VNUS Closure procedure, and endovenous laser
treatment (EVLT). e subsequent combination of methods frustrated any attempt to test each new technique.
Despite this problem, thanks to several authors we now
have evidence on which to base our medicine. Alittle more
4
“medicine-based evidence” is still necessary.
With all the new techniques, the problem has been that
during the last 10years treatments have evolved faster than
the varicose veins of patients. e time-tested and multiply
requested long-term evaluations were not feasible in the
short period of time a er introduction of each new technique. It became obvious that new ideas sprouted before
outcomes of the previous ones were harvested. e current
situation is favourable to endovenous thermal ablation if a
durable suppression of saphenous re ux is desired and the
price not taken into account, favourable to US guided foam
ablation if the cost is an important issue, knowing that the
initial comfort of foam, radial tip laser, and Radio frequency
is much better than that of surgery, and that at 5years global
5
patient’s satisfaction is similar in all groups.
WHAT IS SCLEROFOAM?
P R E P A R A T I O N
All details of all the techniques are extensively and su -
1
ciently described in the literature.
So we will focus on the
most commonly used and well-described methods.
Sclerofoam is obtained by mixing a liquid with a gas. For
sclerotherapy, detergent sclerosing agents such as polidocanol
(POL) and sodium tetradecyl sulfate (STD or STS) are the
most logical ingredients. e usual gas is air, although many
others have been tried or are being used. Foam is obtained
a er repeated alternate passages from one syringe to another
through a connector that may have a reduced diameter to
decrease the size of each foam bubble. is has even been
automated in order to standardize foam (Turbofoam, I2M,
Caen, France). Foam will vary according to the nature of the
sclerosing agent, POL or STS, in its initial concentration;
according to the nature of the gas; and according to the ratio
(volume of liquid:volume of gas) of the mixture. is and the
preparation mode can modify the size of bubbles, their range
of diameters, the “wetness” of the foam, and its overall stability. ese characteristics probably change the power and e cacy, but there are so many variables that this is unclear sofar.
Compared to liquid sclerosing injections, foam has several advantages: a smaller quantity of sclerosing agent to
inject, no dilution with blood, and an even and homogeneous e ect along the injected vein, provided the diameter
6–8
remains reasonable (see Figure19.1).
Another advantage of foam is its ultrasound echogenicity. Liquid/air interfaces act as re ectors, and foam
appears as an excellent contrast medium, even when only
a few bubbles are present. At that stage it has the appearance of a cloud. Denser foam is completely opaque to ultrasound and is completely white, with an underlying acoustic
shadow. is characteristic is helpful in following foam
when injected from a remote injectionpoint.
Except in small veins, liquid sclerosants are diluted by
blood and their e cacy is correct only near the injection
159
A
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foam that is FDA approved. Although practical interest in
this foam is intense because of its proposed sanction, this
is tempered by its cost. Its superiority to homemade foam
remains to be demonstrated.
B
C
D
Figure 19. 1 (A) In small veins (<3mm), liquid sclerosants do not mix and
replace blood. (B) In medium-sized (diameter of 4 to 12mm) varicose
veins, liquids dilute with blood, e cacy is satisfactory only near the
injection site. (C) Injection of foam lls up the vein so that its e cacy is
homogeneous. (D) In large veins, foam oats so its action is limited to
the super cial wall, thus the importance of obtaining venousspasm.
site, where the concentration is powerful enough to initiate
a sclerosing reaction. e main advantage of foam is that it
the vein lumen. e concentration of active sclerosing agent
along the wall is then perfectly homogeneous and even. is
ensures an excellent result except when the vein is too large
and, due to its low density, foam oats in contact with only
the more super cial wall. Obtaining a reduction of venous
diameter by any means, especially by venous spasm, is there-
8
fore of utmost importance.
As derived from Tessari’s method,
9
the most common
method of making foam uses two 5-ml luer lock siliconized
syringes. One syringe contains 1 ml of sclerosing agent at the
desired concentration, the other 4 ml of (sterile, ltered) room
air. Syringes are connected either by a three-way stopcock or
a female/female luer lock two-way connector. en foam is
obtained by cavitation by an average of twenty back-and-forth
passages from one syringe to the other. Stability of this kind
of foam is correct for 1 to 2 minutes, nomore.
A type of commercial foam was still undergoing clinical
trials at the time of preparation of this chapter, Varisolve,
based on Cabrera’s initial microfoam but transformed to
allow a canister-contained mixture to produce ready-made
foam. is system is designed to provide standardized POL
I N J E C T I O N
Two groups of di erent methods are used to inject sclerofoam. Authors usually favor one but use several, if not all,
in various situations. Sclerofoam is primarily used for large
veins, thus it is usually injected with duplex guidance and
duplex control of e cacy.
One main di erence is in the method of venous access,
which can be either an open-vein access (butter y needle,
microcatheter, long catheter) or a direct puncture of the
vein with the needle mounted on the syringe. Open vein
access provides optimal safety since it uses devices designed
for safe and durable venous infusion and allows easy continuous control of blood re ux and adequate positioning of
the needle (see Box19.1).
Open-vein access allows injection of any volume and
repeat injections with additional syringes if necessary. It
is important to emphasize the fact that open-vein access
allows preparation of the foam at the last minute, and rapid
injection of fresh foam. Short catheters and butter y needles have almost the same utility.
Long catheters are still uncommon but may open a new
perspective. e tip can be placed at any level, for example
the (SFJ) junction. A er positioning, the leg can be elevated
and an Esmarch bandage applied. is empties the vein and
then the foam is injected while pulling back the catheter.
is technique, in principle, is comparable to endovenous
ablation, but is much less expensive. Preliminary results are
encouraging, but the technique is more complicated than
open-vein access. Its advantages remain to be demonstrated.
Closed vein access is probably the most common technique, it consists in puncturing and injecting the vein with
the needle mounted on the syringe. Appropriate placement
of the tip of the needle is checked by gentle aspiration end
observation of blood re ux into the syringe. is method
requires training and skill, especially when the US probe is
held by the other hand of the physician, which is our technique of choice.
V A R I C O S E P A T T E R N S W H E N
CONSIDERING ASCLEROSING FOAM
TREATMENT
Sclerofoam allows lling of quite a long segment of vein from
a remote puncture site. erefore, duplex scan evaluation of
varicose patterns must take into account preferential channels
and not just the raw mapping of eye-visible and echo-visible
veins. For instance, the association of incompetent varicose medial leg and thigh tributaries joining an incompetent saphenous vein at mid thigh should be emphasized in
160 • PRIMARY SUPERFICIAL VENOUS INSUFFICIENCY
Box19.1
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STEPBYSTEP ULTRASOUNDGUIDED SCLEROFOAM INJECTION WITH OPEN VENOUS ACCESS
is assumes that a preliminary duplex assessment and mapping of all veins of the lower extremities has already been carried out
and that results have been carefully reviewed.
•
Prepare all necessary materials on atray:
— 25- gauge 3/4-inch butter y needle (for veins no deeper than 1cm) or needle with connector, or 2.5 or 5 mL Syringe and
0.7mm diameterneedle
— two 5-ml luer lock needles, one containing 1 ml sclerosing solution, the other 4 ml of sterile air, attached by a three-way
stopcock or two-way connector
— Adhesive tape, elasto-adhesive tape, cotton balls, medical compression stockings
— Sterile US gel, sterile probecover
•
Map the area to treat with duplex (10-MHz probe necessary), mark possible points of injection possible points of injection
•
Prepare skin
•
Place needle into varicose vein under US guidance with bevel turneddown
•
Verify the ‘ ashback’ or appearance of blood in the hub; secure to the skin with adhesive tape
•
Prepare sclerofoam by twenty alternate passages from one syringe to theother
•
Attach syringe to connector
•
Place probe over needle, check position
•
Inject rst bubbles; check on duplex that bubbles are inside the vein or use the syringe/needle puncture:
•
Prepare foam and adapt the selected needle to the syringe
•
Place US probe longitudinally avec thevein
•
Puncture the skin and push the needle into the vein, remaining in the planeofUS
•
Check the position of the tip into the vein lument, aspirate to check blood is re ux into the syringe, inject a few bubbles in
order to verify needle position
•
Inject sclerofoam, control lling of varicose network with duplex; if necessary massage with probe or hand to ll the desired
venous network
•
Check appearance of venousspasm
•
Remove needle, apply cotton ball and adhesivetape
•
Place foam pad (option), elasto-adhesive tape, and nally grade 2 medical stockings
•
Take some time while the patient is still on the table to explain that walking is recommended, that stockings must be kept on
for 24 hours, and then for 2 weeks daytimeonly
•
Make appointment for next session (duplex evaluation and other injection if necessary).
the scan report. is is one of the best primary indications
for foam sclerotherapy. is pattern requires proper assessment of diameters of both the tributary varicosity and the
saphenous trunk. Many physicians consider that sclerosing
the tributary is the primary aim of their injections. Others
adhere to old surgical dogma that the re uxing saphenous
Comparison with Other Sclerosants and with Other
Choosing Sclerofoam treatment for large veins is an option.
But it implies certain prerequisites and corollaries suchas:
ADVANTAGES OF SCLEROFOAM
Methods (Surgical, Endovenous Ablation)
vein must be obliterated ( rst or at the sametime).
Current respect for the dogma of systematic elimination
of re ux at the saphenofemoral junction may disappear a er
several years of use of endovenous ablation that preserves
the junction. e next, possibly successful, heresy could be
to reject saphenous trunk treatment entirely in some cases.
•
Expertise of the treating physician
•
A clear understanding and agreement between patient and
physician on a treatment program requiring several sessions,
10
additional, repeat injections, and control scans;and
SCLEROFOAM FOR TREATMENT OF VARICOSEVEINS • 161
• Important bene ts such as ambulatory procedures
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without even local anesthesia but with optimal cosmetic
results and cost-e e c t i v en e s s .
Table 19. 1 THEORETICAL VOLUME IN CM 3 OF
AVENOUS SEGMENT CALCULATED FROM THE
FORMULA OF THE CYLINDER
5,11–14
Even today, short- and mid-term results
of foam
sclerotherapy are not inferior to surgery or endovenous
ablation. But long-term results are still under evaluation. Since repeat injections are simple and inexpensive
and cause no disability, evaluation of outcomes of sclerofoam treatment should not require the same end points as
15
surgery.
Sclerofoam sclerotherapy has progressed thanks to a
better understanding of pathophysiology of varicose disease, made possible by duplex ultrasound experience. For a
long time, some 100years, junctional re ux was considered
as the main, if not the only, problem. All treatments up to
1990 were devoted to its eradication. More recent conceptions, however, take into account the role of the varicose reservoir. is is a necessary drainage for incompetent trunks.
It allows demonstration of actual re ux. e varicose reservoir addresses di erent perforating veins di erently. O en
these are not only nonpathogenic but also necessary to
drain varicose clusters (reentry perforators). is understanding of the reservoir function of re uxing varicosities is
also applicable to surgical approaches. Acommon observation is that treating large re uxing tributaries and varicose
clusters can reduce or totally suppress truncal re ux. How
to decide in which cases such an approach is optimal is still
undecided.
H O W M U C H T O I N J E C T ?
e main advantage of sclerofoam is that it lls up the varicose vein without being diluted with blood. It is important
to adjust the injected volume to the length and diameter of
the vein. is can be estimated by a simple calculation using
the formula of the cylinder:
V= π D/2 2 L V=Volume, D=Diameter,
L=Length).
Several results are presented in Table19.1.
Nevertheless, it must be remembered that venous
spasmwill occur a er injection and that massage or alternate compression and release are thought to increase
spasm. e actual volume necessary for an appropriate
result is probably less than that listed in the table. Duplex
control of the distribution of the foam is essential and
allows adapting the volume to speci c conditions. From
this point of view, open-vein access makes the procedure
easier as it allows waiting and seeing and reinjecting if
necessary.
We have recommended limiting the volume of sclerofoam as in Table19.2. is is also recommended by the
16
European consensus.
VEIN
DIAMETER
CM
1.00
0.90
0.80
0.70
0.60
0.50
0.40
0.30
0.20
(From Reference5)
3.93
3.18
2.51
1.92
1.41
0.98
0.63
0.35
0.16
5 7 10 15 20 25 30 35
5.50
4.45
3.52
2.69
1.98
1.37
0.88
0.49
0.22
VEIN LENGTH CM
15.71
11.78
7.85
6.36
5.03
3.85
2.83
1.96
1.26
0.71
0.31
9.54
7.54
5.77
4.24
2.95
1.88
1.06
0.47
12.72
10.05
7.70
5.65
3.93
2.51
1.41
0.63
19.63
15.90
12.57
9.62
7.07
4.91
3.14
1.77
0.79
23.56
19.09
15.08
11.55
8.48
5.89
3.77
2.12
0.94
27.49
22.27
17.59
13.47
9.90
6.87
4.40
2.47
1.10
SIDE EFFECTS OF SCLEROFOAM
Sclerofoam sclerotherapy shares most of its (rare) side e ects
with usual sclerotherapy, but some complications are more
speci c. Visual disturbances are frequently quoted as one
of the main inconveniences of foam, but there is evidence
17
that they are related more to big bubbles than to microbubbles. When visual troubles were observed with liquid, it was
mainly associated with the use of the air block technique.
A er sessions using only sclerofoam, we observed less than
0.25 visual adverse e ects per 100 sessions.
Foam is an excellent contrast medium for ultrasound.
erefore duplex-guided sclerotherapy with foam dramatically improves the safety of sclerotherapy injections
with regard to intra-arterial or extravenous injections. We
17
observed no case of necrosis in the French registry,
and the
number of such accidents reported by French Malpractice
Insurance Company has decreased to zero these last
twoyears.
Venous thrombosis is a complication that has been considered as one of the main drawbacks of sclerotherapy. In
fact, deep venous thrombosis (DVT) has been observed
in very few cases:one DVT in more than 6,000 sessions.
17
Other thrombotic complications also have been observed in
other venous compartments:extension to perforating veins
(two cases) and to muscular veins (three cases). Appropriate
Table 19. 2 CONCENTRATIONS AND VOLUMES FOR
POLFOAM
VEIN FIRST
igh GSV
GSV main tributary
S S V
Perforators
Nonsaphenous site
SESSION
%
2
1
2
1
1
SECOND
SESSION
%
3
1
3
2
2
VOLUME
C C
Up to 8
Up to 4
Up to 4
Up to 2
2 per
162 • PRIMARY SUPERFICIAL VENOUS INSUFFICIENCY
treatment by compression and low molecular weight hepa-
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rin or nonsteroidal anti-in ammatory medications has
always been successful. No pulmonary emboli have been
observed in this series of over 6,000 cases. rombophilia is
suspected in these cases but is not the only etiologic factor.
Another side e ect that must be emphasized is the
increased sclerosing power and the possible excessive
in ammatory or phlebitic reaction produced by the foam.
More than a complication, this is a manifestation of e cacy
of the technique; it indicates that some serious knowledge
and practice are prerequisites to itsuse!
A er injection, some hardening of the tissues and tenderness commonly is observed, even with appropriate compression. e content of the vein is variable and unclear,
sometimes made of pure blood elements, sometimes containing broblasts. Frequently, around the 6th week, the vein
lls again with blood; this might be related to destruction of
the most central layers of the venous wall and bleeding of
the vasa vasorum. is inconvenience is easily cured by small
thrombectomies carried out with a large needle or trocar.
e potential risk of allergy has always been mentioned
in papers devoted to sclerotherapy. However, we did not
observe a single case in the French registry. It makes sense to
consider that foaming does not increase the risk. However,
several (probably less than ve) cases of lethal anaphylaxis
have been reported with liquid sclerosants, and such an
event must be explained to patients when obtaining consent.
e question raised by detection of bubbles in the le
heart circulation is still unanswered, but several factors seem
clear:passage through a patent foramen ovale is possible in
certain patients. No clinical detection is possible, no pretreatment detection is required. In the case of isolated bubbles—
meaning there is no cluster of microbubbles, because in
the injected area they are made only of gas—the interface
with blood does not carry a signi cant number of sclerosing
agent molecules, because they have been diluted. e question of possible pulmonary sclerosis induced by bubbles is
still theoretical and has not been observed clinically.
18
Most recent hypothesis as described by Gillet
19
Frullini
consider the responsibility of endothelin. Finally,
and
no case of sclerofoam injection followed by durable severe
neurological event has been reported sofar.
the passage of the foam into upper, bigger, and deeper veins
is always useful. It is also necessary to remember that in
veins smaller than 3mm, foam has no advantage over liquid.
Appropriate preliminary venous mapping is required in all
cases of varicose vein treatment; post treatment, ultrasound
assessment of results a er several days or weeks is also common practice for most phlebologists.
T R U N C A L V A R I C O S I T I E S
Truncal varicosities must be assessed carefully by duplex
for their whole length. is is true especially for the great
saphenous vein (GSV), because valvular incompetence
is not necessarily total, and very o en the terminal or
preterminal valves are competent. In this situation, this
part of the vein will not need to be treated. It is also necessary to remember that the saphenous trunks are always
intrafascial. e frequent confusion between a varicose
medial super cial tributary and the GSV trunk is responsible for some inappropriate management of varicose vein
patients. What must be done and what is appropriate is
di erent in a saphenous trunk, with its thick venous wall
and distensibility limited by its intrafascial position, and
in a tributary even of large diameter, with its thin venous
wall, remodeling, sensitivity to sclerosing agent, and slow
blood ow.
e approach to complete GSV incompetence, including the saphenofemoral junction, can be accomplished by
direct puncture in the upper third of the thigh and injection of a limited amount of concentrated sclerofoam with a
trend toward reduction of concentration and an increase in
volume and successive injection of the distal trunk. Nobody
advocates injection at the junction level anymore. Our preference is for a more distal approach, between upper and
lower thirds of thigh, and US control of appropriate lling
of the trunk up to the junction. Alternate compression with
the probe may help to an even distribution of foam and to
obtain a spasm of the vein. is approach ensures safety and
comfort for patient and physician. Di erence of e cacy
between the two methods is unknown sofar.
Due to the depth of saphenous trunks and their relative
autocompression by saphenous fascia, thrombectomy a er
foam sclerotherapy is usually not necessary.
SCLEROFOAM IN PARTICULAR
SCLEROFOAM WITH AND WITHOUT
ULTRASOUND GUIDANCE
Obviously, very super cial veins do not need ultrasound
guidance for access, and foam can be injected a er puncture
and simple observation of blood re ux. Furthermore, very
super cial veins are seen only with speci c high-frequency
probes that are not always available. In any case, controlling
SITUAT IONS
SCLEROFOAM FOR TREATMENT OF VARICOSEVEINS • 163
T R I B U T A R I E S
Sclerofoam power allows treatment of a vein with a mild
concentration of sclerosant, which ensures a homogeneous
and even reaction. Tributaries are usually more super cial
than trunks, and their access is easy with butter y needles
(see Figure 19.2). If carefully used, with a lower concentration, sclerofoam decreases the incidence of matting and
residual pigmentation. As explained earlier, thrombectomies may be necessary at 4 to 7weeks.
R E C U R R E N C E S
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Figure 19. 2 is photograph shows the butter y needle taped in place,
the foam in the syringe ready for injection, and the target vein marked
for reference purposes.
PERFORATORS
Perforating veins again raise a common problem:Must we
get rid of all visible or identi ed dilated veins? Speci cally, is
duplex observation of re ux in a perforating vein su cient
to decide that this vein must be treated (sclerosed, ablated,
20,21
and ligated)? is is not certain,
and in many cases, perforating veins act as drainage of varicose clusters (reentries),
and their size decreases signi cantly a er appropriate treatment of the varicose network situated proximally. is is
especially true for the paratibial and posterior tibial perforators (lower third medial lower leg), and much less likely for
perforating veins of the femoral canal (medial thigh). More
precise assessment criteria are needed in order to limit treatment to what is necessary, but a rst approach is to begin
the treatment with the upper network (probable source of
re ux) and to nish with lower elements including perforators (possible reentries).
If sclerofoam treatment of perforating veins is carried
out as in other veins, special attention must be paid to avoid
progression of foam into the deep network. For this reason,
duplex control of foam distribution is essential. Injection
directly in the perforator is dangerous due to the presence
a satellite artery, whos inadvertent injection would cause a
large skin necrosis. Injection of the extrafascial varices close
to emergence of the perforator is recommended.
REVAS (REcurrent Varices A er Surgery) have been the
23
subject of an international consensus conference.
At the
time of the conference, classical sclerotherapy with liquid
was presented as the method of choice for management of
such cases. However, the use of foam is even more e cient
and more practical.
At the saphenofemoral junction, two mechanisms have
been identi ed: neovascularization, where small veins
appear in hard scar tissue and the lymph nodes, and a persistent saphenous stump, corresponding to an inappropriate ligation and division. In the rst case, direct injection
with duplex guidance is possible but requires skill. Aremote
injection with open-vein access allows extensive lling of
the recurrent network. In the second situation the objective
is close to a primary treatment. Sclerofoam is the treatment
of choice. Recurrent varices have unusually thin walls and
are prone to easy sclerosing. ere is no need for strong concentrations; 1% or less POL is usually enough.
RETICULAR AND SPIDERVEINS
Since most visual complications are observed a er use of
Sclerofoam and since superiority of Sclerofoam is counterbalanced by an increase of matting and pigmentation
related to an increased sclerosing power, we reserve the use
of Sclerofoam for telangiectasias and reticular veins to rare,
individualcases.
U P P E R B O D Y
Varicose veins of upper limbs including ngers are rare;
we have treated some with sclerofoam and observed good
results, and it seems unlikely that any large study will be
available on this matter. Regarding sclerotherapy of hand
veins in elderly patients, we do not recommend any such
suppression. Ambulatory phlebectomy has been proposed,
and this kind of treatment of “normal” veins is likely to be
questioned if a venous access is later necessary for other
medical reasons (blood tests, chemotherapy, and emergency
IV injections).
Facial veins are small, foam is not needed, and liquid
sclerosants are usually e cient. We have observed several
good results in sclerotherapy of telangiectasias associated to
venous malformations of theface.
CONTRAINDICATIONS TO
SCLEROFOAM
C H R O N I C V E N O U S I N S U F F I C I E N C Y
In case of chronic venous insu ciency, sclerofoam has
demonstrated excellent results,
improvement in skin changes. Aperiulcerous injection of
sclerofoam appears to be a booster to wound healing.
As indicated earlier, Sclerofoam is responsible for very few
side e ects. However, it should be avoided in patients with
22
and provides dramatic
severe thrombophilias, and carried out with prophylaxis in
less severe thrombophilias. ere is a prospective study currently in progress in France on this very matter.
164 • PRIMARY SUPERFICIAL VENOUS INSUFFICIENCY
Known allergy to POL or STS will not allow the use of
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the speci c agent, but there is no crossed allergy between
these agents.
Disul ram (DCI) is a principal contraindication, but
the total amount of alcohol in POL foam is so low that an
e ect is unlikely.
Tamoxifen (DCI) has demonstrated a potential to
induce super cial venous thrombosis during sclerotherapy; therefore, injections must be postponed to the end of
chemotherapy.
ere is usually no emergency in treating varicose veins,
so a sclerofoam treatment during pregnancy is usually not
necessary. Nothing is known about e ects of sclerosing
molecules on embryos; the principle of precaution should
be applied.
PREREQUISITES FOR CARRYING
OUT FOAM SCLEROTHERAPY
Physician
•
Good understanding and knowledge of venous disorders
•
Good practice of duplex onveins
•
Previous experience of liquid sclerotherapy
•
Skill with syringes and needles
•
Time devoted to training for duplex-guided injection on
phantoms or beefliver
•
Availability for repeat injections
Patient
•
P a ti e n c e
•
Understanding of procedures and postprocedurecare
C O N C L U S I O N S
Even if the physician is open to all available techniques, his
personal preferences in uence his management of varicose disease even before the assessment of varicose patterns.
Satisfaction of the patients’ main concern should be his goal,
and sclerofoam will appear most of the time as the most
“patient-friendly” method. In any case, carrying out such a
treatment requires skill and preliminar y learning and training.
Progress in sclerofoam technique is likely to revolutionize the management of varicose disease. We have always
advocated an à la carte treatment of varicose veins, and it
is now obvious that what we did surgically several years
ago can be done with sclerofoam injections. Active, simple,
inexpensive, and safe, ultrasound-guided sclerotherapy with
foam is the future of varicose treatments.
R E F E R E N C E S
1 . Wo l l ma n n J C . e history of sclerosing foams , Dermatol Surg . 2004 .
30 : 694–703 .
2. Cabrera J , Cabrera Garcia Olmedo JR . Nuevo método de esclerosis
en las varices tronculares , Patol Vasc . 1995 . 4 : 55–73 .
3. Monfreux A . Traitement sclérosant des troncs saphéniens et leurs
collatérales de gros calibre par la méthode MUS , Phlebologie . 1997 .
50 : 351–353 .
4. Knottnerus A , Dinant GJ . Medicine based evidence, a prerequisite
for evidence based medicine, Br Med J . 1997 . 315 : 1109–1110 .
5. Rasmussen LH , Lawaetz M , Bjoern L , Vennits B , Blemings A ,
Eklof B. Randomized clinical trial comparing endovenous laser
ablation, radiofrequency ablation, foam sclerotherapy and surgical stripping for great saphenous varicose veins. Br J Surg . 2011.
98 (8):1079 –10 87.
6. Guex J-J . Foam sclerotherapy:An overview of use for primary venous
insu ciency , Semin Vasc Surg . 2005 . 18 : 25–29 .
7. Guex J-J . Indications for the sclerosing agent Polidocanol® , J Derm
Surg Onc . 1993 . 19 : 959–961 .
8. Goldman MP , Bergan JJ , Guex JJ . Sclerotherapy, treatment of varicose
and telangiectatic leg veins , 4e. NewYork ; Elsevier . Inpress.
9. Tessari L . Nouvelle technique d’obtention de la scléromousse ,
Phlebology . 2000 . 53 : 129 .
10. Pittaluga P , Rea B , Barbe R . Méthode ASVAL (ablation sélective des
varices sous anesthésie locale):Principes et résultats intermédiaires ,
Phlebologie . 2005 58 : 175–181 .
11. Barrett JM , Allen B , Ockelford A , Goldman MP . Microfoam
ultrasound guided sclerotherapy treatment for varicose veins in a
subgroup with diameters at the junction of 10mm or greater compared with a subgroup of less than 10mm, Dermatol Surg . 2004 .
30 : 1386–1390 .
12. Yamaki T , Nozaki M , Iwasaka S . Comparative study of duplex
guided foam sclerotherapy and duplex guided liquid sclerotherapy
for the treatment of super cial venous insu ciency , Dermatol Surg .
2004 . 30 : 718–722 .
13. Hamel-Desnos C , Desnos P , Wollmann JC , Ouvry P , Mako S , Allaert FA .
Evaluation of the e cacy of polidocanol in the form of foam compared
with liquid form in sclerotherapy of the great saphenous vein:Initial
results , Dermatol Surg . 2003 . 29 : 1170–1175 ; discussion1175.
14. Barrett JM , Allen B , Ockelford A , Goldman MP . Microfoam ultrasound guided sclerotherapy of varicose veins in 100 legs , Dermatol
Surg . 2004 . 30 : 6–12 .
15. Guex J-J , Isaacs MN . Comparison of surgery and ultrasound guided
sclerotherapy for treatment of saphenous varicose veins:Must the criteria for assessment be the same?, Int Angiol . 2000 . 19
16. Rabe E , Breu F , Cavezzi A , et al.; for the Guideline Group.
European guidelines for sclerotherapy in chronic venous disorders.
Phlebology .2013.
17. Guex J-J , Allaert FA , Gillet JL , Chleir F . Immediate and midterm
complications of sclerotherapy report of a prospective multi-center
registry of 12,173 sclerotherapy sessions , J Dermatol Surg . 2005 .
31 : 123–128 .
18. Gillet JL . Neurological complications of foam sclerotherapy:fears
and reality. Phlebology . 2011. 26 (7):277 –27 9.
19. Frullini A , Barsotti MC , Santoni T , Duranti E , Burchielli S , Di
Stefano R. Signi cant endothelin release in patients treated with
foam sclerotherapy. Dermatol Surg. 2012. 38 (5):741–747.
20. Guex J-J . Ultrasound guided sclerotherapy for perforating veins ,
Hawaii Med J . 2000 . 59 ( 6 ): 261 .
21. Danielsson G , Eklof B , Kistner RL . What is the role of incompetent perforator veins in chronic venous insu ciency? , J Phleb . 2001 .
1 : 67–71 .
22. Bergan JJ , Pascarella L . Severe CVI : Primary treatment with sclerofoam , Semin Vasc Surg . 2005 . 18 : 49–56 .
23. Perrin MR , Guex JJ, Ruckley CV, et al. Recurrent varices a er
surgery (REVAS), a consensus document , Cardiovasc Surg . 2000 .
8 : 233–245 .
( 4 ): 299–302 .
SCLEROFOAM FOR TREATMENT OF VARICOSEVEINS • 165
20.
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SCLEROSANTS IN MICROFOAM
A NEW APPROACH IN ANGIOLOGY
Juan Cabrera , Maria V. Rubia , and Juan Cabrera Jr.
INTRODUCTION
e onset of re ux and the subsequent development of varicose veins requires a connection between the triad made
up of the origin of re ux, the transmission route, and the
end vessel. ese three elements are present in all patients
with varicose veins. e origin of re ux can be identi ed
with hand-held Doppler device or duplex ultrasound. en
it can be eliminated. It is the least important, because the
absence of functioning valves in any site is of little importance if the blood cannot move in a retrograde direction.
Transmission routes are anatomically highly variable but
are readily identi ed using physical and color duplex ultrasound examinations. eir stable elimination can be con rmed by follow-up visits.
e key to therapeutic success in treating venous insuf ciency lies in the complete, rigorous, and con rmed elimination of all varicose veins of leg, ankle, and foot. If this
objective is not achieved, recurrence is possible. Both, endoluminal and surgical procedures, when used alone, face di culties in completely eliminating all varicose veins in a limb.
Even when these approaches are combined it is not uncommon that a few incompetent veins persist even though they
are poorly developed at the time of treatment. ese missed
veins may lead to recurrence of varicoseveins.
Sclerotherapy, a classic therapy of recognized potential
2,3
but limited e ectiveness has entered a new era.
e drastic
limitations imposed by its use in liquid form, subject to progressive dilution and inactivation in the blood and very dif cult to control when within a vessel, have been overcome.
Since 1993, our experience and that of others has demonstrated the e ectiveness of duplex ultrasound-guided
microfoam sclerotherapy. is has been successfully used
not only in patients with varicose leg veins, traditionally
4–6
indicated for surgery,
that resist surgical treatment
venous hypertension,
but also in venous malformations
7
8,9
and in leg ulcers caused by
thus extending the limits of sclero-
therapy and raising expectations for this approach. As
1
10
Bergan
said, “foam sclerotherapy reaches its highest pinnacle of success in treating venous leg ulcers.” e old concept of foam sclerotherapy has been brought back tolife.
e simplistic analogy between foam and microfoam,
the great ease with which foam can be produced, and the
absence of available pharmaceutical grade microfoam has
led to a multiplicity of e orts to use foam for sclerotherapeutic purposes. ere have been numerous reports of
results obtained with heterogeneous types of foam produced by various but similar homemade methods,
11–15
a variety of application techniques. However, major di erences in the physics and intravascular dynamics of foams
and microfoam, especially the speci c pharmaceutical grade
microfoam currently in US Phase III clinical trial, suggest
that a cautious view should be taken toward the use of foam.
e publication of several cases of ischemic stroke a er the
administration of homemade foams has raised concerns
about the safety of their use without following strict pre-
16–20
cautions.
Tegernsee consensus
At the very least, the recommendations of the
21
should be followed on the injectable
volume of homemadefoams.
e drawbacks of foams include the composition of
the gas mixture used, commonly atmospheric air (with a
high content of low soluble Nitrogen) or even less soluble
22
their high degree of coalescence and their variabil-
gases,
ity in internal cohesion, and the variability in the dose of
liquid sclerosant that a given volume of foam contains as
23
well as the diameter of the bubble.
Microfoam has overcome these shortcomings. Nevertheless, optimization of the
application technique and the development of increasingly
e ective safety measures remain an ongoing challenge.
MECHANISM OFACTION
Micronization of the bubbles creates an optimal structure to
endow the liquid sclerosant with the largest possible surface
area and to facilitate its contact with the endothelium. e
using
166
active surface area of the liquid sclerosant increases exponen-
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tially with a reduction in the diameter of the bubbles. When
these sclerosant vectors possess the appropriate internal
cohesion, they can physically displace the blood contained
in the vessel. In this way, the liquid can be homogeneously
distributed at a known concentration on an extensive endothelial surface. e ideal foam should have a speci c diameter of the bubbles, gas composition, gas-liquid ratio, and
internal bubble cohesion. e correct combination of these
factors together with the proper application technique are
all key parameters for the safety and e cacy of the procedure. Our proprietary microfoam successfully incorporates
these basic elements and has, in combination with our application technique, yielded previously unmatched therapeutic
outcomes with a high degree of safety.
Although some of these diverse types of foams, when
compared with liquids, can be more e ective in eliminating varicose veins, they may not be safer. Homemade foams
may not ful ll pharmaceutical grade standards because of
the gases used, the variable dose of liquid sclerosant in a
given volume of foam and their even more variable physical characteristics, including those that are manufactured
with a mixture of CO
O 2 . ey represent a stopgap mea-
2-
sure before the arrival of a registered and standardized
product.
SAPHENOUS VEIN TREATMENT
e rst step in our procedure for treating the great saphenous vein (GSV), consists in the injection of 1% polidocanol microfoam using a 20-gauge short catheter (51-mm
length) placed in the vein at mid/lower third of the thigh
in distal direction. With the leg raised, we inject the volume
required to totally ll the GSV in the thigh ( lling volume).
When the microfoam is seen to arrive at the saphenofemoral junction, the injection is stopped. Approximately 10 to
20 cc are injected, depending on the dimensions of the vein
2
). e microfoam must remain con ned to the vein to
(πr
avoid lling the super cial tributaries at this high concentration, thereby preventing overdose of super cial veins and
an undesirable in ammatory reaction.
We then aspirate with a syringe to see the color of the
intraluminal content, repeating the injection of an appropriate volume of microfoam (renewal volume) one or two
times, if necessary, until a white aspirate is obtained, indicating that the segment contains only microfoam. e
renewal volume is considerably smaller than the lling
volume because the vein segment already contains microfoam, and only 2 to 3 cc are needed to e ectively renew the
content. Excess microfoam drains into the femoral vein but
is practically inactive, since it is at the proximal end of the
“pneumatic piston” that displaced the blood in the vein at
the rst injection and has undergone major dilution and
inactivation.
INTRAVASCULAR LIMITATIONS
OF CIRCUMFERENTIAL
COMPRESSION
Based on our observations, using color duplex ultrasound,
compression stockings of 35 mmHg have no noticeable
e ect on the morphology or function of large varicose
veins. Even when rolls of gauze or other nonelastic cylinders are placed on the varicose vein and strongly compressed
by a bandage of little elasticity (Peha-Ha ; Hartmann), no
reduction in the diameter of trunk varicose veins is produced
when the patient is in a standing position. us, the joint
application of these compressive measures (i.e., stocking +
bandage + nonelastic cylinders) does not occlude the lumen
of the vessel. Since the vein preserves its dimensions, there
is nothing to prevent the formation of a thrombus. For that
reason, we use the proximal sclerosis approach. e involution of tributaries a er the proximal occlusion (see above)
is very important because it prevents the formation of a big
thrombus and its undesirable side e ects (Figure20.1).
FOLLOWUPCARE
When the patient, still wearing the compression stocking,
returns to the clinic 10 to 15days a er the treatment, we
verify the occlusion of the treated proximal segment and
check the involution of varicose veins tributary to this
segment (see Figures20.2 and 20.3). During this second
Figure20.1 Skin in ammatory reaction a er injection of polidocanol
microfoam inaGSV.
SCLEROSANTS IN MICROFOAM:ANEW APPROACH IN ANGIOLOGY • 167
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