sclerosing foam in the treatment of venous ulcers of lower limbs

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