GENERAL ARTICLE

Ultrasound-Guided Foam Sclerotherapy for TreatingIncompetent Great Saphenous Veins—Results of 5 Years ofAnalysis and Morphologic Evolvement Study

CHIEN-HSUN CHEN, MD,*† CHENG-SHENG CHIU, MD,*† AND CHIH-HSUN YANG, MD*†

BACKGROUND Varicose veins of the lower leg is a common disease and is associated with long-termmorbidity. It has been treated using high ligation with stripping and endovenous laser surgery of the greatsaphenous vein (GSV).

OBJECTIVES To investigate the clinical outcomes of GSV insufficiency after ultrasound-guided foamsclerotherapy (UGFS) using 3% sodium tetradecyl sulfate (STS).

METHODS Between 2005 and 2009, patients with symptomatic varicose veins secondary to GSV insuffi-ciency were enrolled; 3% STS foam was injected into the GSV under ultrasound visualization. Ultrasoundexaminations and clinical follow-up were performed at 3- to 6-month intervals. Follow-up visits continuedthrough April 2011.

RESULTS Two hundred 88 limbs of 233 patients were enrolled. The mean follow-up interval was37.8 months. Occlusion was achieved for 89.6% of the incompetent veins in two sessions of UGFS. Themean number of therapy sessions per leg was 1.53. The internal diameters of the treated veins reduced to66.9% 3 months and 32.7% at 12 months.

CONCLUSIONS UGFS is effective in sealing incompetent GSV segments. It is a minimally invasive proce-dure and can be redone several times in cases of recurrence. UGFS is simpler and less painful than strip-ping surgery and endovenous laser treatment.

The authors have indicated no significant interest with commercial supporters.

For almost 100 years, varicose veins have been

treated using sclerosing solutions. An ideal

sclerosing solution should irreversibly destroy the

endothelial cell layer and subsequently cause vein

fibrosis without damage to the adjacent normal

vessels and tissue. Various components of liquids

such as absolute alcohol, hypertonic saline, polyio-

dinated iodine, and glycerin have been used as scle-

rosants for injection.1 For most cases, the use of

these sclerosants fails to yield good results for

occlusion of incompetent, dilated great saphenous

veins (GSV) because, after injection, the sclerosant

is diluted with the blood, and the concentration of

the sclerosant becomes too low to induce irrevers-

ible vascular endothelial injury on the entire vein

segment. Detergent sclerosing solution (polidocanol

[POL] and sodium tetradecyl sulfate [STS]) can be

converted into foam by vigorous mixing with air.

The foam microbubbles come in homogeneous

contact with the vein endothelium at an undiluted

concentration, so the foam sclerosant causes more

damage to the vessels than a liquid sclerosant does.

Foam sclerotherapy is mostly performed on blue

reticular veins, perforator veins, and branches of

the saphenous vein.2–4 With respect to foam sclero-

therapy for incompetent GSV main trunks, the

number of patients studied has been small and the

follow-up short.5–7 The aim of this study was to

*Department of Dermatology, Chang Gung Memorial Hospital, Taipei, Taiwan; †Chang Gung University College ofMedicine, Tao-Yuan, Taiwan

© 2012 by the American Society for Dermatologic Surgery, Inc. � Published by Wiley Periodicals, Inc. �ISSN: 1076-0512 � Dermatol Surg 2012;1–7 � DOI: 10.1111/j.1524-4725.2012.02408.x

1

evaluate the efficacy and safety of ultrasound-

guided foam sclerotherapy (UGFS) for treating

incompetent trunks of the GSV.

Materials and Methods

Over a 5-year period, from August 2005 through

October 2009, patients with symptomatic varicose

veins secondary to GSV insufficiency (CEAP classi-

fication C3–6, EpAsPr) were enrolled. GSV insuffi-

ciency, defined as duration of reflux longer than

0.5 s starting from the saphenofemoral junction

(SFJ), was detected using duplex ultrasound.

Patients who had previously undergone sclerotherapy

or vascular surgery of the lower extremities were

excluded. Follow-up visits continued through April

2011.

Sclerosing foam was generated using the Tessari

technique.8 One part 3% STS (Fibrovein, STD

Pharmaceutical, Hereford, UK) and four parts air

were mixed to produce the sclerosing foam. We

used two latex-free disposable plastic 10-mL

syringes; one syringe contained 2 mL of 3% STS

in the liquid form, and the other contained 8 mL

of air. The outlets of the syringes were connected

using a three-way stopcock. The contents of both

syringes were pumped backward and forward,

causing a turbulent flow that generated foam.

Optimal foam was produced after 20 passages.

For performing injections, patients were placed in

the supine position with the treated leg slightly

elevated and rotated outward. A 25-g, 1.5″ needle

was inserted at midthigh level. The needle was

advanced under ultrasound visualization. When

the needle tip was confirmed to be located within

the GSV, the sclerosing foam was injected.

Spreading of the hyperechoic foam column to the

SFJ and vasospasm could be observed was consid-

ered to be the treatment endpoint. As the foam

spread to the SFJ, an assistant immediately com-

pressed the SFJ to prevent the foam from flowing

into the deep venous system. Patients were

instructed to lie in supine position and compress

the SFJ using a 5-pound sand bag for 10 min

after receiving the injection to prevent dislocation

of the foam column into the common iliac vein.

A single injection in the thigh was usually suffi-

cient. To avoid unwanted foam passage into the

perforator causing femoral vein damage, ultra-

sound examination was carefully performed to

detect any perforator vein connected to the femo-

ral vein at midthigh. If one was found, the

midthigh perforator vein was compressed with a

bandage followed by two injections at the proxi-

mal and the distal thigh of the GSV. As for severe

bulging and tortuous extrafascial varicose veins

below the knee, an additional three injections of

1.5% STS were performed using a 27-gauge nee-

dle. After sclerotherapy, all treated legs were

placed in class II, 30- to 40-mmHg graduated

compression hosiery for at least 1 week. All

patients were instructed to walk at a moderate

pace immediately after therapy.

At the first visit, 1 week later, patients were asked

about side effects, including visual disturbances,

headaches, chest tightness, and leg swelling.

Duplex ultrasound was performed to look for deep

vein thrombosis (DVT). Patients were followed up

at 1 weeks, 2 weeks, 1 months, 3 months,

6 months, and thereafter every 6 months. Repeated

duplex ultrasound examination was performed at

each follow-up visit using the same protocol to

determine the changes and patency of the treated

GSV with the patient standing. The internal diame-

ter of the vein was measured at two sites: 5 cm

below the SFJ and at midthigh level. The treatment

was considered successful if absence of reflux or

reflux flow of <0.5 s for the entire treated segment

was observed during the follow-up ultrasound

examination. Patients received a second ultra-

sound-guided 3% STS foam injection if vein recan-

alization or persistent reflux of longer than 0.5 s

was observed.

Results

The therapy was performed for 288 limbs in 233

patients (165 women, 68 men); 156 left and 132

FOAM SCLEROTHERAPY FOR TREATING INCOMPETENT GSV

DERMATOLOGIC SURGERY2

right legs, including both legs in 55 patients, were

treated. The mean age of the patients was 60.1

(range 27–88). Mean follow-up time was

37.8 months from the first therapy session. The

average volume of 3% STS foam administered in

the first injection was 9.7 mL (range 6–16 mL).

Duplex ultrasound examination showed that 173

of the 288 (60.1%) legs were free of reflux after

one session of therapy. Of the remaining cases, 85

(29.5%) were free of reflux after the second session

of therapy and 24 (8.3%) after the third. The mean

time interval between the first and second session

was 3.2 months. Of the six (2.6%) limbs in which

the GSV was not occluded after three injections,

four had an initial vein diameter greater than

10.0 mm and two greater than 8.0 mm. The mean

number of treatment sessions required to treat a

leg for GSV insufficiency was 1.53. Follow-up ran-

ged from 18 to 68 months. The mean number of

treatment sessions needed was 1.47 (n = 19) for

patients with a follow-up period of longer than

5 years, 1.57 (n = 51) for 4 to 5 years, 1.61

(n = 70) for 3 to 4 years, 1.34 (n = 94) for 2 to

3 years, and 1.70 (n = 54) for 1.5 to 2 years

(Figure 1 and 2).

In 52 patients with 65 treated limbs, vein diameter

was precisely measured using duplex ultrasound

scanning at 1 weeks, 2 weeks, 1 months,

6 months, and 12 months. The mean pretreatment

vein diameter 5 cm below the SFJ was 7.57 mm.

The internal diameters of the treated veins were

unchanged at the first and second week after ther-

apy. Involution was gradual; the internal diameter

of the vein at midthigh level at 1, 3, 6, and

12 months was 79.3%, 66.9%, 44.8%, and 32.7%

68~60 monthsN=19

60~48 months N=51

48~36 months N=70

36~24 months N=94

24~18 months N=54

sessions 1.47 1.57 1.61 1.34 1.7

0

0.2

0.4

0.6

0.8

1

1.2

1.4

1.6

1.8

Sess

ions

of f

oam

scl

erot

hera

py

Figure 1. Treatment sessions needed for 3% sodium te-tradecyl sulfate ultrasound-guided foam sclerotherapyaccording to the follow-up time.

(A) (B) (C)

Figure 2. Clinical results seen with 3% sodium tetradecyl sulfate foam sclerotherapy (A) before treatment and (B) 3 weeksafter treatment. Superficial thrombophlebitis was observed in the calf on previous severe dilated varices. Removal ofcoagulum helps to reduce the tenderness and pigmentation. (C) There is marked improvement of a varicosity of thegreater saphenous vein 9 months after treatment.

CHEN ET AL

2012 3

smaller, respectively. The internal diameter of the

vein 5 cm below the SFJ at 1, 3, 6, and 12 months

was 88.7%, 50.2%, 37.5%, and 30.7% smaller,

respectively (Figure 3). The treated GSV were as

narrow as fibrotic cords (internal diameter,

<2.2 mm) approximately 12 months after therapy

(Figure 4).

Some patients developed thrombophlebitis over the

treated veins, mostly in large extrafascial varices

close to the skin in the calf. Early and repeated

evacuation of the trapped coagulum using a 18-G

needle under local anesthesia helped to relieve the

redness, tenderness, and subsequent overlying skin

hyperpigmentation. No cases of anaphylaxis, deep

vein thrombosis, intra-arterial injection, skin necro-

sis, visual disturbance, or other significant adverse

events were found.

Discussion

An ideal sclerosant would induce target vessel fibro-

sis without recanalization. Vascular fibrosis and

obliteration occur after irreversible destruction of

the endothelial and subendothelial cellular layers of

the treated vein segment, but obliteration of large

veins using a sclerosant is difficult. Foam sclerother-

apy has an advantage over liquid sclerotherapy that

involves the dilution of the sclerosant with blood in

that the injected foam sclerosant pushes the blood

backward, leading to little dilution of the drug.9,10

Furthermore, the spreading of the foam within the

0 1wk 2wk 1m 3m 6m 12m5 cm below SFJ 7.57 7.43 6.98 6.72 3.8 2.84 2.33mid-thigh 6.65 6.73 6.08 5.28 4.45 2.98 2.18012345678Vein diameter (mm)

Figure 3. Internal diameter of the vein measured 5 cmbelow the saphenofemoral junction and at midthigh level1 week, 2 weeks, 1 month, 3 months, 6 months, and12 months after foam sclerotherapy.

Figure 4. Duplex ultrasound scanning of the great saphenous vein 5 cm below the saphenofemoral junction (A) beforetreatment (B) 3 weeks after foam sclerotherapy. Perivascular hazy shadow was observed. The internal diameters of thetreated veins were unchanged. (C) Three months after treatment. The size of treated vein was decreased. (D) The treatedgreat saphenous veins were fibrosed 6 months after treatment.

FOAM SCLEROTHERAPY FOR TREATING INCOMPETENT GSV

DERMATOLOGIC SURGERY4

vessels and vasospasm after the injection can be

detected in real time by performing duplex ultra-

sound scanning because of the hyperechoic signal

of the foam. Hence, a foam sclerosant can be safely

introduced inside the GSV under direct visualiza-

tion. To limit endothelial injury to a controlled

area, patients were instructed to remain in a supine

position and compress their SFJ in the groin area

for 10 min after injection. The abnormally dilated

GSV segments were perfused with the sclerosant,

and the foam was prevented from entering the deep

venous system. Foam prepared according to the

Tessari technique has a half-life of approximately

90 s.11 Therefore, the procedure should be com-

pleted within 1 min, or the foam will separate into

two phases: liquid and air.

Various injection techniques and sclerosants have

been selected to treat varicose veins. Islamoglu

used high ligation plus 3% POL foam injection

from a catheter into the entire saphenous vein.12

Hamahata and colleagues used 1 to 2 mL of 3%

POL foam at midthigh and a second injection

3 cm above the knee.7 Myers and colleagues

injected 3 to 40 mL (median 5 mL) of 3% POL or

3% STS foam using a 1.5″ 25-G needle from a dis-

tal part of the limb.13 Bradbury and colleagues

used 18- to 22-G cannulae under local anesthesia

with each injection of small volume foam aliquots

(2 mL) down the trunk vein to minimize the deep

passage of foam sclerosant.14 We used a 25-G,

1.5″ needle to inject 3% STS foam at the midthigh

and let it flow proximally to the SFJ and distally to

the varicosity around knee. Five to 8 mL of foam

sclerosant can fill up the incompetent, dilated

saphenous trunk according to the vein diameter.15

Usually, a single injection in the thigh was suffi-

cient, although preoperative duplex ultrasound

examination was important because the perforator

vein may connect to the femoral vein at midthigh

(Hunterian perforator). In such cases, adequate

pressure should be applied over perforators, fol-

lowed by administration of two injections—one

each at the proximal and distal thigh of the GSV—

and the flow of the foam is carefully monitored

using ultrasound. This technique prevents

unwanted flow of the sclerosant down the perfora-

tors causing femoral vein occlusion, which has

been reported in balloon catheter–directed foam

sclerotherapy.16,17 Additional multiple small-dose

injections (1–2 mL) using a 27-G needle are per-

formed in the bulging and tortuous varicose vein

below the knee to minimize the spread of foam

into the deep venous system, because there are

many perforators on the calf. These strategies help

to deliver an adequate amount of foam sclerosant

to achieve therapeutic effect with a small number

of adverse events.15,18 The whole injection proce-

dure can be completed in 3 min. We observed no

deep vein thrombosis, visual disturbances, or

neurologic or other significant adverse events.

The use of compression hosiery for 1 week and

patient ambulation maintains the deep vein flow

and prevents thrombus propagation from the SFJ.

In this study, no deep vein thromboses were

observed, although despite good compression,

superficial thrombophlebitis due to blood trapping

is commonly encountered, especially in large extra-

fascial varices in the calf. Early repeated evacua-

tion of the trapped coagulum using an 18-G needle

under local anesthesia performed every week after

treatment helps relieve redness and tenderness. Hy-

perpigmentation of the overlying skin usually sub-

sides in 6 to 12 months, but in a few cases,

hyperpigmentation persists over a year.19,20

Few reports have examined the outcomes of UGFS

for GSV insufficiency. Pang and colleagues reported

an 82% wound healing rate 1 month after their

first foam sclerotherapy. Barrett and colleagues

reported a success rate of 97% (GSV complete scle-

rosis or <3 mm and minimal flow) at 22.5 months

with a mean of 2.19 treatment sessions. Darvall

and colleagues also reported that a single session of

foam sclerotherapy completely eradicated GSV

reflux in 97% of patients at 12 months. In our

long-term follow-up study, duplex-guided foam

sclerotherapy was also effective in treating GSV

insufficiency, with 89.6% of GSV free of recanali-

CHEN ET AL

2012 5

zation with two sessions of therapy during a mean

37.8 months of follow-up. Clinical studies on endo-

venous laser therapy showed that 90% to 95% of

the saphenous trunks are occluded 2 years after

therapy.21,22 Foam sclerotherapy is a simpler, fas-

ter, and more cost-effective than endovenous laser

treatment, and it can be repeated several times in

cases of recurrence. UGFS has replaced 80% of our

endovenous laser procedures.

GSV treated using foam sclerotherapy will eventu-

ally shrink, although the time to achieve fibrosis

for treated GSV after foam sclerotherapy

(12 months) was much longer than the time to

achieve fibrosis after endovenous laser surgery

(5.8 months),23 probably because of the thermal

effect of the laser–tissue interaction, which can

induce panluminal destruction and early tissue con-

traction, whereas chemical ablation using a sclero-

sant is mostly limited to the endothelial layer of

the vessel.24 The vein wall thickening and perivas-

cular tissue blurring observed after endovenous

laser surgery are more prominent than in foam

sclerotherapy using duplex ultrasound examina-

tion. In this study, the four of the six patients in

whom occlusion of the GSV was not achieved

within three sessions had an initial vein diameter

larger than 10 mm. Thus, endovenous laser and

stripping or ligation surgery is the treatment alter-

native for severe dilated incompetent GSV.15,21,25

In conclusion, our results for UGFS were promis-

ing, with achievement of effective occlusion of

GSV segments in 95% of patients and no compli-

cations at up to 37.8 months. Large-scale long-

term studies should be conducted to determine the

optimal protocol for foam sclerotherapy and to

investigate the role of different sclerosants such as

POL for treating chronic venous insufficiency.

References

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3. Murad Alam SS. Procedures in cosmetic dermatology series:

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4. Hsu TS, Weiss RA. Foam sclerotherapy: a new era. Arch

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Address correspondence and reprint requests to:Chih-Hsun Yang, MD, Department of Dermatology,Chang Gung Memorial Hospital, 199, Tung-HwaNorth Road. Taipei, Taiwan, ore-mail: dermadr@hotmail.com

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