Dr. Maurizio RonconiDr. Edoardo Cervi

Clinica Chirurgia Spedali Civili di Brescia

Sclerosing foam in the treatment of venous ulcers of lower limbs

Epidemiology

> 6 million persons

Teatment costs up to $ 2,5 billion

2 million lost workdays

1% of total health costs of developoed countries1% of total health costs of developoed countries

anno

1% of the population

NHS cost £ 400-600 million

3% of total costs on health care

anno

Leg’s ulcer natural history

Healing ratesHealing rates

68 – 83%68 – 83%

Multilayer elastic compression bandagingLeg elevationMedications

Antibiotic therapyStockings

very slowly healingvery slowly healing

elevated recurrence rateelevated recurrence rate

venous refluxvenous reflux

Visible varicosities only in about 40% of patients with superficial venous reflux

Duplex ultrasonography studies in legs with chronic ulceration show

reflux:51-53% in superficial system alone32-44% in both systems5-15% in deep system alone

Leg’s ulcer and venous reflux

Recurrence rates after healing

Study F-up Reflux Compression alone

Barweel JREurop J Vasc Endovasc Surg 2000

non random

1 year superficial 28%

ZamboniEurop J Vasc Endovasc Surg 2003

random 3 years superficial 38%

14%

9%

Compression + relux surgery

242

compression + surgery

258 compression alone

500 randomised500 randomised

1418 patients assessed

Healed legs not recurred

66%

85%

82%

76%Ulcer healing

• 1995 - Juan Cabrera: rotating brush

technique

• 1997 - Alain Monfreuax: low pressure

tecnique and “Methode MUS”

•1944 Orbach

•1949 Sigg

•1956 Fluckiger Arve Ree

•1957 Mayer/ Brucke

History of sclerosing foam

2nd European Consensus Meeting on Foam Sclerotherapy - Tegernsee, Germany

F. X. Breu et al., Supplement 71, February 2008, 3 VASA 2008; S/71: 3–29

Conclusions

“…Foam Sclerotherapy has become an

established treatment option for

varicosis and has undoubtedly

improved the management of varicose

veins.”

F. X. Breu et al., Supplement 71, February 2008, 3 VASA 2008; S/71: 3–29

898 (92%)106GSV recurrent

37220 (86%)257GSV primary

39285 (88%)324GSV treated STD

633 (80%)39GSV treated POL

15189 (93%)203GSV <¼ 5 mm dia

30130 (81%)160GSV > 5 mm dia

45318 (88%)363GSV

135SSV primary

126SSV treated STD

15SSV treated POL

79SSV <¼ 5 mm dia

62SSV > 5 mm dia

24

21

4

11

14

25

111 (82%)

105 (84%)

11 (73%)

68 (86%)

48 (77%)

116 (82%)141SSV

N. patientsVein status 11 months

after treatment

occlusion reflux808

Surgery for varicose veins is widely used in the UK but recurrence may be expected in 25-50% of patients at 5 years

Surgery leaves scars and may result in damage to adjacent structures including nerves, lymphatics, major arteries and veins. Deep vein thrombosis and pulmonary embolism occur

Eur J Vasc Endovasc Surg Vol 32, November 2006

“This technique is useful in the management of chronic venous

disease as an alternative to surgery”

Conclusions

116 consecutive patients

Microfoam F-up

Healing 83%6 monthsRecurrence rate 8%

“… This minimally invasive procedure may become the treatment of choice

for venous ulcers in the future.”

27 patientsCEAP C6Reflux:

•SVR: 20 patients•SVR + DVR: 7 patients

Median Foam: 8 ml

70%

93%Ulcer healing

Venous occlusion

Median F-up Compression + foam

sclerotherapy

Healing 12 months 93%Recurrence rate 12 months 7%

“…eradication of superficial venous reflux (SVR) improves chronic venous ulcer outcome

when compared to compression alone…”

“…UGFS appears to be at least as effective as surgery as a means of dealing with SVR…”

Conclusions

53 patients with leg ulcer

Personal experience

january 2006 – march 2007

personal and family history

clinical examination

ABPI index

venous duplex scan

Inclusion crtiteria

Open ulcer

Healed ulcer within preceding 6 months

ABPI > 0.9

Venous reflux (superficial and/or deep) on duplex

31 patients eligible for study

CEAP

C5 - C6

Patients characteristics

17

14

maschi

femmine

Sex F : 17 M: 14

1

2

3

5

6

11

0

2

51-60 61-70 71-80 81-90

Agemedian 66 (range

57/76)

July 1, 2009July 1, 2009

Methods

Bacteriological swabs

Wound infection:

Staph. Aureus

Ps. Aeruginosa

Enterococcus

Proteus Mirabilis

E. Coli

11 (34,3%34,3%))

Disinfection

31 patients

19 patientsGroup 1

Multilayer elastic compression bandaging

Wound care primary (idrocolloidi) advanced (Ag ionizzato, ac. ialuronico)

II class compression stockings

12 patientsGroup 2

II class compression stockings

Foam sclerotherapy

Polidocanolo 3%

Wound care

primary (idrocolloidi) advanced (Ag. ionizzato, ac.

ialuronico)

Personal tecnique of UGFS

Treatment required time: 30 min (median)

Repeat venous duplex scanning prior to treatment

Patient in supine (GSV) or prone (SSV) position

Saphenous trunk incanulated with a peripheral intravenous catheter 23 G under direct ultrasound guidance

1 – 2 cannulae inserted according to the extent of reflux

Sclerosing foam prepared in according to Tessari’s method

3% Sodium tetradecyl sulphate or 3% Polidocanolo

Median foam session: 8 ml

II class compression stocking, left in place for 4 days (night

included)

Follow-up

Clinical examinationDupplex scan8 days after

sclerofoam

2nd Foam sessionevery 8 days

(if necessary and until reflux controll)

at 1, 6, 12 months after last foam

Clinical examinationDupplex scan

Group 2Group 1

at 1, 6, 12 months

compression bandaging

every 8 days

Clinical examinationDupplex scan

Results at 12 months

31 patients

16 healed

group 1

6 recurrence 1 recurrence11 healed

group 2

84% 91%n.s.

32% 9%

P < 0.001

February 12, February 12, 20102010

Thank you for your kindly

attention