This document provides guidelines for foam sclerotherapy treatment of varicose veins and superficial venous insufficiency. It discusses indications for treatment, sclerosing agents such as polidocanol and sodium tetradecyl sulfate, how to make and administer foam, and results from studies on occlusion rates. Foam sclerotherapy is recommended for treating saphenous veins and tributaries as it displaces blood better than liquid sclerosants, allowing for more effective endothelial contact and occlusion rates of 70-90% in studies with follow-up periods of 6-46 months and a single treatment session in most cases. Compression is also important after the procedure.

1. A. KURSAT BOZKURT, MDA. KURSAT BOZKURT, MD
University of IstanbulUniversity of Istanbul
Cerrahpasa Medical FacultyCerrahpasa Medical Faculty
20112011
SCLEROTHERAPY

4. Treatment of CEAP 1Treatment of CEAP 1

9. Guidelines for liquid or foamGuidelines for liquid or foam
(Modified from: Handbook of venous disorders, Guidelines of the(Modified from: Handbook of venous disorders, Guidelines of the
American Venous Forum, 2009)American Venous Forum, 2009)
Vein sizeVein size SodiumSodium
TetradecylsulfateTetradecylsulfate
PolidocanolPolidocanol
TelangiectasiasTelangiectasias 0.124-0.25%0.124-0.25% 0.5%0.5%
1-3 mm1-3 mm 0.5-0.75%0.5-0.75% 0.75-1%0.75-1%
3-6 mm3-6 mm 1-3%1-3% 2-3%2-3%
>6 mm>6 mm FoamFoam FoamFoam
Sapheno-femoralSapheno-femoral
and sapheno-and sapheno-
popliteal ins.popliteal ins.
FoamFoam FoamFoam

10. Treatment of ≥ CEAP 2Treatment of ≥ CEAP 2

11. ≥≥ CEAP 2CEAP 2
OptionsOptions!!
 SurgerySurgery
 Interventional TechniquesInterventional Techniques
• LaserLaser
• RadiofrequencyRadiofrequency
• FoamFoam SclerotherapySclerotherapy

12.  Questions regardingQuestions regarding Laser andLaser and
RFRF!!
• CostsCosts (=surgery, > foam)(=surgery, > foam)
• Long term dataLong term data

SafetySafety
 ComplicationsComplications

13. The aim of this presentation is toThe aim of this presentation is to
review the current data regardingreview the current data regarding
foam sclerotherapy for the treatmentfoam sclerotherapy for the treatment
of superficial venous insufffiencyof superficial venous insufffiency

14.  In 1995, Antonio Luis CabreraIn 1995, Antonio Luis Cabrera
reintroduced foam created usingreintroduced foam created using
carbon dioxide mixed withcarbon dioxide mixed with
polidocanolpolidocanol

15. Questions!Questions!
1. Indications1. Indications
2. Why foam instead of l2. Why foam instead of liquidiquid??
3. Which sclerosant agent?3. Which sclerosant agent?
4. How to make foam4. How to make foam
Concentration of agentConcentration of agent
5. How to administer (catheter directed ?)5. How to administer (catheter directed ?)
6. Results6. Results
7. Complications7. Complications

16. IndicationsIndications
 Treating saphenous veins primarilyTreating saphenous veins primarily
 Incompetent tributariesIncompetent tributaries
 As complementing procedure toAs complementing procedure to
endovenous laser, RF or surgeryendovenous laser, RF or surgery
 Postsurgical recurrencePostsurgical recurrence
 Venous malformationsVenous malformations
 Venous aneurysmsVenous aneurysms
 Saphenous and nonsaphenous perforatingSaphenous and nonsaphenous perforating
veinsveins

17. Why foam?Why foam?

18. Liquid Sclerosants!Liquid Sclerosants!
May damage endothelium to causeMay damage endothelium to cause
fibrosisfibrosis
But:But:
 Mixing with blood dilutes sclerosantMixing with blood dilutes sclerosant
 Causes sclero-thrombusCauses sclero-thrombus
 Leaves living adventia and mediaLeaves living adventia and media
 High recanalisation ratesHigh recanalisation rates

19. Foam!Foam!
Displaces bloodDisplaces blood
 Better endothelialBetter endothelial
contactcontact
 Less sclero-thrombusLess sclero-thrombus
 CheaperCheaper
 Easy to followEasy to follow
with Duplexwith Duplex

20. Foam SclerotherapyFoam Sclerotherapy

21. Ouvry P, Allaert FA, Desnos P, Hamel-Desnos C. Efficacy of polidocanol foam versusOuvry P, Allaert FA, Desnos P, Hamel-Desnos C. Efficacy of polidocanol foam versus
liquid in sclerotherapy of the great saphenous vein: a multicentre randomised controlledliquid in sclerotherapy of the great saphenous vein: a multicentre randomised controlled
trial with a 2-year follow-up.trial with a 2-year follow-up. Eur J Vasc Endovasc SurgEur J Vasc Endovasc Surg 2008;2008;3636:366–70:366–70
 The relative efficacy of foam and liquidThe relative efficacy of foam and liquid
sclerotherapy has been investigatedsclerotherapy has been investigated
 Either 2–2.5 mL of 3% POL liquid or foamEither 2–2.5 mL of 3% POL liquid or foam
into the GSV under ultrasound guidanceinto the GSV under ultrasound guidance
 On only one occasion.On only one occasion.
Successful
obliteration
•35% of liquid-treated
patients and 85% of foam-
treated patients after 3
weeks
•53% of foam-treated and
12% of liquid-treated
patients after 2 years

22. SclerosantsSclerosants
 PolidocanolPolidocanol
 Sodium tetradecyl sulphateSodium tetradecyl sulphate
 Sodium salicylateSodium salicylate
 Chromated glycerineChromated glycerine
 Hypertonic glucoseHypertonic glucose

23. Are there any difference?Are there any difference?
Goldman MP. Treatment of varicose and telangiectatic leg veins:Goldman MP. Treatment of varicose and telangiectatic leg veins:
double-blind prospective comparative trial between aethoxyskerol anddouble-blind prospective comparative trial between aethoxyskerol and
sotradecol Dermatol Surg. 2002 ;28(1):52-5sotradecol Dermatol Surg. 2002 ;28(1):52-5
 129 patients were treated with either129 patients were treated with either
polidocanol or sodium tetradecyl sulfatepolidocanol or sodium tetradecyl sulfate
 All patients had an average of 70%All patients had an average of 70%
improvement and were 70-72% satisfiedimprovement and were 70-72% satisfied
in all vein categories treated with eitherin all vein categories treated with either
solutionsolution
 There was no significant difference inThere was no significant difference in
adverse effects between each groupadverse effects between each group
except for a decrease in ulcerations andexcept for a decrease in ulcerations and
swelling in the polidocanol groupswelling in the polidocanol group

24. Polidocanol might be better!Polidocanol might be better!
(Mechanism of action of sclerotherapy, In: Goldman MP, Bergan JJ,(Mechanism of action of sclerotherapy, In: Goldman MP, Bergan JJ,
Guex JJ. Sclerotherapy, 2007)Guex JJ. Sclerotherapy, 2007)
 Less painLess pain
 Less cutaneous ulceration (<1%Less cutaneous ulceration (<1%
solution)solution)
 Allergic reactionsAllergic reactions →→ rarerare
 Less pigmentationLess pigmentation

25. How to make foam?How to make foam?
 Variety of Techniques to make foamVariety of Techniques to make foam
–– Tessari, Monfreaux, machinesTessari, Monfreaux, machines
etcetc
 Variety of Concentrations (0.5% -Variety of Concentrations (0.5% -
3%)3%)
 Variety of GassesVariety of Gasses
–– Air, Oxygen / Carbon DioxideAir, Oxygen / Carbon Dioxide
mixesmixes

27.  A 5A 5 µµm intravenous filter can bem intravenous filter can be
inserted between the syringesinserted between the syringes
(Improves the quality of the foam!)(Improves the quality of the foam!)
 One part of sclerosant to four parts ofOne part of sclerosant to four parts of
gas seams idealgas seams ideal
 The sclerosant may be sodiumThe sclerosant may be sodium
tetradecyl sulphate 1–3% ortetradecyl sulphate 1–3% or
polidocanol 0.5–3%.polidocanol 0.5–3%.
 The mixture is oscillated vigorouslyThe mixture is oscillated vigorously
between the two syringes about 20between the two syringes about 20
timestimes

31. Hamel-Desnos C, Ouvry P, Benigni JP,Hamel-Desnos C, Ouvry P, Benigni JP, et alet al. Comparison of 1% and 3% polidocanol foam. Comparison of 1% and 3% polidocanol foam
in ultrasound guided sclerotherapy of the great saphenous vein: a randomised, double-in ultrasound guided sclerotherapy of the great saphenous vein: a randomised, double-
blind trial with 2 year-follow-up. ‘The 3/1 Study’.blind trial with 2 year-follow-up. ‘The 3/1 Study’. Eur J Vasc Endovasc SurgEur J Vasc Endovasc Surg 2007;2007;3434:723–:723–
99
 Assessing the relative efficacy of 1% andAssessing the relative efficacy of 1% and
3% sclerosant foam3% sclerosant foam
 Either 1% or 3% polidocanol foam, in aEither 1% or 3% polidocanol foam, in a
single sessionsingle session
 An average of 4.5 mL of foamAn average of 4.5 mL of foam
 Immediate occlusion rates were 96% (3%Immediate occlusion rates were 96% (3%
foam) and 86% (1%) foamfoam) and 86% (1%) foam
 After two years saphenous occlusion wasAfter two years saphenous occlusion was
seen in 69% and 68%seen in 69% and 68%
(In this study a rather small volume of foam was used(In this study a rather small volume of foam was used
compared with the maximum of 10 mL recommended dose)compared with the maximum of 10 mL recommended dose)

32.  The optimum ratio of gas to liquid isThe optimum ratio of gas to liquid is
4:1, although a range of ratios is4:1, although a range of ratios is
reported in published work.reported in published work.
 There is a wide variation in theThere is a wide variation in the
volume, but <10 ml seems safe andvolume, but <10 ml seems safe and
effective enaugheffective enaugh

33. How to administerHow to administer
 Both saphenous trunks and majorBoth saphenous trunks and major
tributaries may be treated throughtributaries may be treated through
an intravenous cannula or Butterflyan intravenous cannula or Butterfly
needleneedle (Foam and liquid sclerotherapy for varicose veins, P(Foam and liquid sclerotherapy for varicose veins, P
Coleridge Smith, Phlebology. 2009;24 Suppl 1:62-72Coleridge Smith, Phlebology. 2009;24 Suppl 1:62-72
 Catheter directed sclerotherapyCatheter directed sclerotherapy ((Catheter-Catheter-
directed sclerotherapy, K Parsidirected sclerotherapy, K Parsi Phlebology 2009;24:98-107)Phlebology 2009;24:98-107)

37. Tumescent ELLETumescent ELLE (from Parsi et al)(from Parsi et al)
Access can be gained at the level
of the knee to treat the proximal
great saphenous vein or at medial
ankle to treat the full length of the
vein
Catheter is advanced to approximately
5 cm from the SFJ
Tumescent anaesthesia
compresses the vein
and achieves an ‘empty vein
Foam is injected as the catheter
withdrawn

38.  PainlessPainless
 Requires no power source and the cost ofRequires no power source and the cost of
consumables lower than laser orconsumables lower than laser or
radiofrequencyradiofrequency
 Tumescent ensures minimal vesselTumescent ensures minimal vessel
diameterdiameter →→ especially useful for very largeespecially useful for very large
veinsveins
 Progressive withdrawal of the catheterProgressive withdrawal of the catheter
while injecting the sclerosantwhile injecting the sclerosant →→ goodgood
distribution of foam along the length of thedistribution of foam along the length of the
target vessel.target vessel.

39. Parsi 2009Parsi 2009
 Based on the current level ofBased on the current level of
evidence, no firm conclusionevidence, no firm conclusion
regarding the efficacy of CDSregarding the efficacy of CDS
techniques can be drawn intechniques can be drawn in
comparison with EVLA or RFAcomparison with EVLA or RFA
 Primary success rate is probablyPrimary success rate is probably
higher than the standard UGShigher than the standard UGS
(No controlled trial!)(No controlled trial!)

40. Perforating vein treatmentPerforating vein treatment

41. The importance of compressionThe importance of compression

42. ResultsResults
 No good data!!No good data!!
 Prospective, randomizedProspective, randomized
controlled trialscontrolled trials
comparing allcomparing all
endovascular modalitiesendovascular modalities
(EVLA versus RFA(EVLA versus RFA
versus foam) withversus foam) with
traditional stripping aretraditional stripping are
necessarynecessary

43. Coleridge Smith P. Chronic venous disease treated byColeridge Smith P. Chronic venous disease treated by
ultrasound guided foam sclerotherapy.ultrasound guided foam sclerotherapy. Eur J VascEur J Vasc
Endovasc SurgEndovasc Surg 2006;2006;3232:577–83:577–83
 457 legs457 legs
 Follow-up: 6Follow-up: 6–46–46 ((average 11average 11))
monthsmonths
 DuDuplex examinationplex examination: O: Occlusion hadcclusion had
been obtained in 322 of 364been obtained in 322 of 364 GSVGSV
(88%). SSV occlusion was present(88%). SSV occlusion was present
in 118 of 143 (83%).in 118 of 143 (83%).

44. Mid Term Results of Ultrasound Guided Foam Sclerotherapy forMid Term Results of Ultrasound Guided Foam Sclerotherapy for
Complicated and Uncomplicated Varicose Veins.Complicated and Uncomplicated Varicose Veins.
J.L. O'Hare et al, Eur J Vasc Endovasc Surg. 2008;36(1):109-13 .J.L. O'Hare et al, Eur J Vasc Endovasc Surg. 2008;36(1):109-13 .
Occlusion rates six months after foam sclerotherapy related to target vein
GSV SSV AASV Other Total
Occluded 48 (72%) 1 (20%) 12 (100%) 7 (88%) 68 (74%)
Partially occluded 7 (10%) 2 (40%) 0 (0%) 0 (0%) 9 (10%)
Patent 12 (18%) 2 (40%) 0 (0%) 1 (12%) 15 (16%)
Total 67 5 12 8 92
GSV great saphenous vein; SSV small saphenous vein, AASV anterior accessory saphenous
vein.
91% of the patients had single treatment session!

45. P Chapman-Smith and A Browne. Prospective five-year study ofP Chapman-Smith and A Browne. Prospective five-year study of
ultrasound-guided foam sclerotherapy in the treatment of greatultrasound-guided foam sclerotherapy in the treatment of great
saphenous vein reflux.saphenous vein reflux. Phlebology 2009;24:183-188Phlebology 2009;24:183-188
Number of treatments Average % Repeat UGFS N
Year 1 1–9 2.53 0 203
Year 2 1–7 2.0 16.5 188
Year 3 1–6 2.04 8.2 121
Year 4 1–6 2.43 6.7 75
Year 5 1–2 1.5 8.8 34

46. Rates of recurrence
Year 1 n
= 167
(%)
Year 2 n
= 108
(%)
Year 3 n
= 72
(%)
Year 4 n
= 32
(%)
Year 5 n
= 23
(%)
Clinical recurrence
No venous
symptoms
84 89 76 88 74
Minimal venous
symptoms
16 11 18 12 22
Significant venous
symptoms
0 0 6 0 4
Ultrasound recurrence
Venous closure 60 56 51 56 35
Any US
recurrences
29 28 25 31 30
New varicose veins 4 8 8 0 17
Combined
new/recurrent
7 7 15 13 17

47. Status of the saphenofemoral junction (SFJ) (n = 175)
Year 1 n
= 120
(%)
Year 2 n
= 78 (%)
Year 3 n
= 55 (%)
Year 4 n
= 28 (%)
Year 5 n
= 18 (%)
SFJ closed 26 29 25 36 28
SFJ open and
competent
33 34 35 21 28
SFJ open and
incompetent
41 37 40 43 44
% efficacy 59 63 60 57 56

48. Comments of the authorsComments of the authors
 All patients reported excellent resolution ofAll patients reported excellent resolution of
venous symptoms after five years, despitevenous symptoms after five years, despite
demonstrable ultrasound recurrence.demonstrable ultrasound recurrence.
 Further UGFS treatment maintainedFurther UGFS treatment maintained
control of this recurrent diseasecontrol of this recurrent disease
 Neovascularization characteristically seenNeovascularization characteristically seen
after flush saphenous ligation is not seenafter flush saphenous ligation is not seen
after UGFS.after UGFS.
 A statistically significant reduction in theA statistically significant reduction in the
diameter of the GSV was demonstrated indiameter of the GSV was demonstrated in
all cases of GSV reflux, sustained over theall cases of GSV reflux, sustained over the
five-year period.five-year period.

49. The recent metaanalysis!The recent metaanalysis!
 van den Bos R, Arends L, Kockaert M, et al. Endovenousvan den Bos R, Arends L, Kockaert M, et al. Endovenous
therapies of lower extremity varicosities are at least astherapies of lower extremity varicosities are at least as
effective as surgical stripping or foam sclerotherapy: Meta-effective as surgical stripping or foam sclerotherapy: Meta-
analysis and meta-regression of case series andanalysis and meta-regression of case series and
randomised clinical trials. J Vasc Surg 2009;49:230–239randomised clinical trials. J Vasc Surg 2009;49:230–239
 64 studies64 studies
 USG examinationUSG examination
 12320 limbs12320 limbs
 Follow-up: 32monthsFollow-up: 32months

50. 92,9
95,4
80,4
75,7
82,1
73,5
88,8
79,9
0
10
20
30
40
50
60
70
80
90
100
Laser Surg Foam RFA
3month
5year

51. ComplicationsComplications
 Forlee reported a stroke patientForlee reported a stroke patient
following foam treatment thatfollowing foam treatment that
highlights the potential hazard ofhighlights the potential hazard of
injecting foam into varicose veinsinjecting foam into varicose veins
 Such events are rare consideringSuch events are rare considering
millions of patients who have beenmillions of patients who have been
treated worldwidetreated worldwide

52. Microembolism during Foam Sclerotherapy of VaricoseMicroembolism during Foam Sclerotherapy of Varicose
Veins. Ceulen et al. NEJM, 358:1525-1526, 2008Veins. Ceulen et al. NEJM, 358:1525-1526, 2008
 Transient scotoma and migraine attact in 2Transient scotoma and migraine attact in 2
patients following foampatients following foam
 Echocardiography detected a patentEchocardiography detected a patent
foramen ovale in eachforamen ovale in each
 They monitored by echocardiography theThey monitored by echocardiography the
foam distribution during foam sclerotherapyfoam distribution during foam sclerotherapy
in 33 consecutive patientsin 33 consecutive patients
 A single injection of 5 ml of 1% polidocanolA single injection of 5 ml of 1% polidocanol
foam (air-to-liquid ratio, 4:1).foam (air-to-liquid ratio, 4:1).
 In five patients, microembolism was alsoIn five patients, microembolism was also
detectable in the left atrium and ventricledetectable in the left atrium and ventricle
 PFO and right-to-left shunt in 5 patientsPFO and right-to-left shunt in 5 patients

54.  Prevalence of PFO: 26% in thePrevalence of PFO: 26% in the
general population.general population.
 Serious neurologic symptomsSerious neurologic symptoms
(scotomas, migraine, and stroke)(scotomas, migraine, and stroke)
after foam sclerotherapy may occurafter foam sclerotherapy may occur
in 1-2% of patientsin 1-2% of patients
 Caution when foam sclerotherapy isCaution when foam sclerotherapy is
performed in patients with a knownperformed in patients with a known
patent foramen ovale!patent foramen ovale!
 Routine echocardiography beforeRoutine echocardiography before
foam?foam?

55. Other complicationsOther complications
 Respiratory problemsRespiratory problems
 Venous thromboembolismVenous thromboembolism
 Superficial thrombophlebitis (1-33%)Superficial thrombophlebitis (1-33%)
• Beyond the region treatedBeyond the region treated
• Significantly worse inflammatonSignificantly worse inflammaton
 Tissue necrosisTissue necrosis
 HematomasHematomas

56. Safety improvement techniquesSafety improvement techniques
 Indwelling catheters (balloonIndwelling catheters (balloon
tipped?)tipped?)
 Volume reductionVolume reduction
 Non-air based foamNon-air based foam (70% CO(70% CO22/30%O/30%O22
would produce 7-40 times less adverse effects)would produce 7-40 times less adverse effects)
 Pre-injection leg elevationPre-injection leg elevation
 Post-injection leg elevationPost-injection leg elevation

57. Personel viewPersonel view
 LSV + SSV + PerforatorsLSV + SSV + Perforators
Catheter thermoablation replacedCatheter thermoablation replaced
open surgeryopen surgery
Personel experience > 750Personel experience > 750
patients!patients!
 Foam is a good optionFoam is a good option →→ needs toneeds to
prove safety and >5 years efficacyprove safety and >5 years efficacy
for routine usagefor routine usage
 Neurogical complications?Neurogical complications?

58. Importance of guidelinesImportance of guidelines

59. Guidelines for Radiofrequency (4.9.0)Guidelines for Radiofrequency (4.9.0)
(Robert F. Merchant, Robert L. Kistner. In: Handbook of venous disorders, Guidelines of(Robert F. Merchant, Robert L. Kistner. In: Handbook of venous disorders, Guidelines of
the American Venous Forum, 2009)the American Venous Forum, 2009)
Grade ofGrade of
recommendationrecommendation
(1, we(1, we
recommend; 2, werecommend; 2, we
suggestsuggest
Grade of evidenceGrade of evidence
(A, high quality;(A, high quality;
B,moderateB,moderate
quality; C, low orquality; C, low or
very low qualityvery low quality
Radiofrequency ablation ofRadiofrequency ablation of
the great saphenous vein isthe great saphenous vein is
safe and effective and wesafe and effective and we
recommend it for treatmentrecommend it for treatment
for saphenous incompetencefor saphenous incompetence
11 AA
Clinical outcome after RFClinical outcome after RF
ablation of the saphenousablation of the saphenous
vein up to 5 years isvein up to 5 years is
comparable to traditionalcomparable to traditional
stripping and ligationstripping and ligation
-- CC

60. Guidelines for Endovenous Laser (4.10.0)Guidelines for Endovenous Laser (4.10.0)
(Nick Morrison. In: Handbook of venous disorders, Guidelines of the American Venous(Nick Morrison. In: Handbook of venous disorders, Guidelines of the American Venous
Forum, 2009)Forum, 2009)
Grade ofGrade of
recommendationrecommendation
(1, we(1, we
recommend; 2, werecommend; 2, we
suggestsuggest
Grade of evidenceGrade of evidence
(A, high quality;(A, high quality;
B,moderateB,moderate
quality; C, low orquality; C, low or
very low qualityvery low quality
Endovenous laser therapy ofEndovenous laser therapy of
the great saphenous vein isthe great saphenous vein is
safe and effective and wesafe and effective and we
recommend it for treatmentrecommend it for treatment
for saphenous incompetencefor saphenous incompetence
11 AA
Clinical outcome afterClinical outcome after
endovenous laser therapy 3endovenous laser therapy 3
years is comparable toyears is comparable to
traditional stripping +traditional stripping +
ligation and we recommendligation and we recommend
it for treatment of theit for treatment of the
incompetent GSVincompetent GSV
11 CC

61. Guidelines for foam sclerotherapy (4.6.0)Guidelines for foam sclerotherapy (4.6.0)
(Joshua I. Greenberg, Niren Angle, John Bergan. In: Handbook of venous disorders,(Joshua I. Greenberg, Niren Angle, John Bergan. In: Handbook of venous disorders,
Guidelines of the American Venous Forum, 2009)Guidelines of the American Venous Forum, 2009)
Grade ofGrade of
recommendationrecommendation
(1, we(1, we
recommend; 2, werecommend; 2, we
suggestsuggest
Grade of evidenceGrade of evidence
(A, high quality;(A, high quality;
B,moderateB,moderate
quality; C, low orquality; C, low or
very low qualityvery low quality
We suggest the use of foamWe suggest the use of foam
sclerosant for the treatmentsclerosant for the treatment
of symptomatic reflux of theof symptomatic reflux of the
GSV, C2-C6 varicose veins,GSV, C2-C6 varicose veins,
and requrrent varicose veinsand requrrent varicose veins
22 BB
We suggest the use of foamWe suggest the use of foam
sclerotherapy to treatsclerotherapy to treat
saphenous vein, tributarysaphenous vein, tributary
varicose vein, and perforatorvaricose vein, and perforator
vein incompetence invein incompetence in
patients with venous ulcers,patients with venous ulcers,
lipodermatosclerosis, andlipodermatosclerosis, and
venous malformations whenvenous malformations when
compared with conservativecompared with conservative
therapytherapy
22 BB

62. ThanksThanks