Original Article

Vascular and Endovascular Surgery

1-6
Results of Ultrasound-Guided Foam ª The Author(s) 2016
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Sclerotherapy of the Great Saphenous Vein DOI: 10.1177/1538574416675482
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With New Parameters of the Technique

A. Baeshko, PhD1,2, N. Shestak, MD3, and S. Korytko, MD4

Abstract
Aim: To report the outcome of a series of patients with chronic venous disease due to incompetence of the great saphenous vein
(GSV) managed by ultrasound-guided foam sclerotherapy (USGFS). Design: Controlled clinical trial with maximum 5-year follow-
up of results of USGFS of the GSV with new parameters of the procedure. Materials and Methods: This research analyzes the
results of USGFS of the GSV (395 GSV) and its tributaries in 326 patients with varicose veins of the lower extremities over the
period from January 2009 to January 2014 with the following parameters of the procedure: 60 limb elevation, calf bandage, and
cooled foam injection. Results: Ultrasound control of 395 GSV after the first injection of sclerosant from the sixth to the eighth
day revealed GSV occlusion in the femoral segment with the absence of reflux in 94.9% of cases (375 GSV). After 5-year follow-up,
GSV occlusion was diagnosed in 91.9% of cases. Conclusion: Our improved technique of foam sclerotherapy allows improving
immediate and long-term results. This technique is characterized by the low incidence of side effects and complications.

Keywords
varicose veins, USGFS, the great saphenous vein

Introduction by using a cooled foam solution. Compared to room tempera-

Sclerotherapy has gained wide popularity among phlebologists
of the world through the development and introduction of new
technologies such as ultrasound guidance and foam sclero-
sant.1,2 Our own experience of great saphenous vein (GSV)
foam sclerotherapy (over 3500 procedures) shows that the con-
ventional technique (horizontal limb position during foam
injection)3,4 fails to completely fill the GSV lumen with foam.
Ultrasound examination of foam injection with the leg horizon-
tal shows that the foam does not completely displace blood
from the GSV. Instead, foam mixes with blood and remains
near the anterior wall of the vein, leaving areas of the GSV
unfilled with foam.4 Although 30 limb elevation reduces the
GSV diameter, blood still enters the vein and prevents com-
plete filling with foam. In addition, the foam as a gaseous
substance migrates into the distal bed (veins of the calf), which
reduces the degree of filling of the femoral segment of the
GSV. All of the above decrease the frequency of GSV occlu-
sion, increase possibility of blood flow recovery, and, in the
long term, promote the recurrence of the disease.
Based on our experience, we believe improving the outcome
of ultrasound-guided foam sclerotherapy (USGFS) requires full
exsanguination of the GSV trunk in order to concentrate the
foam in the femoral GSV segment. Achieving a so-called
empty vein requires limb elevation of 60 or more and com-
pression wrapping of the calf to reduce superficial venous bed
capacity. Moreover, the efficacy of sclerotherapy will increase
ture foam, cooled solution has higher stability and density that
increases vasospasm and enhances damage of the venous wall.5
Materials and Methods
The ethics committee of the 4th N.E. Savchenko City Clinical
Hospital approves the publication of this article (protocol no.
36484, dated November 17, 2014).
Patients
Between January 2009 and January 2014, 326 consecutive
patients (395 legs) admitted to outpatient clinic comprise this
series. All of them had symptomatic (CEAP C2-6) venous dis-
ease and significant reflux in a segment of calf GSV and/or
distal thigh GSV on duplex ultrasound (DUS).
1
Department of Topographic Anatomy and Operative Surgery, Belarusian
State Medical University, Minsk, Belarus
2
‘‘Ecomedservice’’ Medical Center, Minsk, Belarus
3 th
4 N.E. Savchenko City Clinical Hospital, Minsk, Belarus
4
Republic Center for Medical Rehabilitation and Balneotherapy, Minsk, Belarus
Corresponding Author:
N. Shestak, Department of Vascular Surgery, 4th N.E. Savchenko City Clinical
Hospital, Rosa Luxemburg str, 110, Minsk 220036, Belarus.
Email: dr.shestak@gmail.com

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2 Vascular and Endovascular Surgery
Figure 1. GSV diameter dependence on the position of the limb (the arrow is pointing to the GSV) A, the horizontal position (Ø GSV – 7.06
mm); B, 20 leg elevation (Ø GSV – 4.65 mm); C, 60 leg elevation (Ø GSV – 0.91 mm).
Exclusion criteria were previous deep vein thrombosis
(DVT), history of arterial insufficiency or ankle–brachial pres-
sure index below 0.9 or both, axial deep venous insufficiency
(femoral or popliteal vein or both), inherited thrombophilia,
and lower limb features that don’t allow the usage of compres-
sion stockings (obesity, posttraumatic foot deformity).
Pretreatment Assessment
Duplex ultrasound of superficial, deep, perforating, and com-
municating veins of the lower extremities was performed
before sclerotherapy in all patients. The insufficiency of the
saphenofemoral junction (SFJ) and saphenopopliteal junction
(SPJ), diameter of GSV at the terminal portion (5 cm from the
SFJ), the presence of pathological reflux, its duration and the
prevalence in the GSV, its tributaries, and deep veins were
assessed. All veins were assessed for patency and compressi-
bility. Reflux was defined as reserved flow for >0.5 seconds.
Ultrasound-Guided Foam Sclerotherapy Treatment
Under ultrasound guidance, an 18-gauge cannula (Optiva 2,
Medex Medical Ltd, Rossendale, United Kingdom) was placed
in the GSV just above the knee with the patient in the supine or
semirecumbent position. Before closing the cannula, it was
flushed with normal saline both to clear it of blood and to
confirm its position within the vein by visualizing flow in the
proximal vein with DUS imaging.
The limb to be treated was then elevated to 60 to max-
imize the ‘‘exsanguination’’ of the veins. The elevation of the
limb was maintained throughout the procedure by a foot sup-
port attached to the operation table. Complete disappearance of
the lumen of the GSV and the lack of blood in it were con-
firmed by DUS (Figure 1), as well as a full migration of blood
from the opened cannula (for comparison, during the procedure
with supine limb position, there is always intense retrograde
flow from the cannula).
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To prevent distal migration of the foam due to leg elevation
(foam as a gaseous substance will move up into the calf veins),
we applied an elastic bandage from foot to knee to concentrate
the foam in the femoral segment of the GSV.
Thereafter, cooled foam was made. The ampoule with
polidocanol (Aethoxysklerol; Kreussler Pharma, Wiesbaden,
Germany), syringes (Becton Dickenson, Huesca, Spain), and
3-way taps (B Braun Medical, Sheffield, United Kingdom) were
placed in the freezer (1 C) 5 minutes before the application to
reduce its temperature. Foam was prepared by a Tessari method
and then injected. An ideal temperature for the cooled foam was
as low as possible (1 C). Cooled 1% polidocanol foam was used
in patients with superficial saphenous vein (<0.5 cm from the
skin surface) with a diameter of 7 mm or less. Deeper and larger
diameter GSV segments were treated with 3% cooled foam.
Blood flow in the deep veins was encouraged after each
injection by asking the patient to perform a series of dorsiflex-
ions at the ankle in order to minimize the risk of DVT. One
puncture and 2 injections (up to 10 mL) of foam were per-
formed during 1 treatment session. When the entire GSV trunk
was in spasm, and occluded with foam, the cannula was
removed. There was an interval of 5 to 10 minutes after scler-
otherapy before the leg moved into the supine position, to avoid
possible displacement of the foam column.
Short-stretch compression bandaging was applied to the
limbs. Peha-haft cohesive bandage (Peha-haft, Hartmann, Ger-
many) was used with Velband (Johnson & Johnson Medical,
Ascot, Berkshire, United Kingdom) cotton wool padding
applied over the saphenous trunks to increase compression. A
class 2 medical compression stocking was measured and
applied over the bandage to secure the bandage (Sigvaris
AG, St Gallen, Switzerland). The stockings were worn continu-
ously (day and night) for 5 to 7 days and then daily for 1 month
from the date of the last sclerotherapy session.
The distal GSV and other prominent tributaries were often
injected separately via a 23-gauge butterfly needle (Abbot Ire-
land, Sligo, Ireland) during further sessions of USGFS with the
Baeshko et al 3

same technique (60 elevation of the limb, calf bandage, injec- Table 1. Characteristics of Patients, Legs, and Veins Treated.
tion of cooled foam). Treatment sessions were carried out at
Number,
intervals of 1 week. Variable Value %
After each procedure, patients are recommended to walk for
30 to 40 minutes. No specific analgesia was prescribed. All Sex Male 20 (6.1)
patients were encouraged to resume work and normal activity Female 306 (93.9)
as soon as they were able. Age <30 years 25 (7.7)
31-40 years 183 (56.1)
41-49 years 99 (30.4)
Outcome Measures and Follow-Up 50-59 years 12 (3.7)
>60 years 7 (2.1)
Repeat DUS and clinical examination were performed at each Side Right 88 (27.0)
follow-up visit (1 week, 6 months, and 5 years). Occlusion of Left 169 (51.8)
the treated saphenous trunk was determined by a lack of com- Both 69 (21.2)
pressibility and the absence of any flow. Complete occlusion CEAP clinical grade C2 148 (37.5)
was defined as occlusion over the entire length of the GSV. C3 223 (56.4)
Recanalization was defined as the presence of flow in either an C4 9 (2.3)
C5 13 (3.3)
antegrade or a retrograde direction in a previously occluded
C6 2 (0.5)
GSV. Patients with residual reflux or recanalization at any Etiology Primary (Ep) 395 (100)
follow-up appointment were offered further treatment by Secondary (Es) 0
repeating foam sclerotherapy. In all cases, reflux was elimi- Anatomical patterns of venous Superficial and deep 7 (1.8)
nated in a month after the first sclerotherapy session. reflux (Asd)
Superficial only (As) 388 (98.2)
Pathophysiological classification Reflux (Pr) 395 (100)
Statistics Obstruction (Po) 0
Variables are expressed as counts and percentages. We esti- Reflux in the GSV GSV distal thigh 395 (100)
GSV calf 363 (91.9)
mated proportions on successful outcomes at each time point
Diameter of the GSV 4.0-6.0 mm 118 (29.9)
and compared them by Cochran-Armitage trend test.6 A 6.1-8 mm 163 (41.2)
P value of <0.5 was considered statistically significant. 8.1-10.0 mm 86 (21.8)
Analyses were conducted using R version 3.1.3 software.7 >10 mm 28 (7.1)
Perforator venous reflux PV of the femoral canal 51 (12.9)
Paratibial PV 131 (33.2)
Results Posterior tibial PV 73 (18.5)
History of DVT No 326 (100)
Patients and Treatments Yes 0
Patient characteristics are shown in Table 1. Saphenous trunks
Abbreviations: DVT, deep vein thrombosis; GSV, great saphenous vein; PV,
were injected first and any residual varices treated in subsequent perforator veins.
sessions. There was no need for additional sessions of focused
sclerotherapy of incompetent perforating veins of a thigh or calf.
One percent polidocanol was used in 438 (34.2%) treatment
sessions and 3% polidocanol in 841 (65.8%) sessions. The total
One-Week Follow-Up
number of treatment sessions (1-6) in 1 patient varied depend- An ultrasound examination performed 6 to 8 days after the first
ing on the diameter of the GSV and the prevalence of reflux, as session of sclerotherapy confirmed occlusion of the femoral
well as the number of extended tributaries (anterior and poster- segment of the GSV in 309 patients (375 GSV; 94.9% of
ior accessory GSV), unilateral or bilateral vein lesions, and cases). All occluded GSV segments were noted to be noncom-
results of the previous procedure (Table 2). The minimum pressible with no evidence of antegrade or retrograde flow
(1-2) number of sessions of sclerotherapy needed to achieve (Figure 2).
a positive result was obtained only in 14.8% of patients, 3 In 20 cases (5.1%) of the SPJ, the preterminal segment and,
sessions—48.6% in patients with unilateral lesion of the GSV in some of them (10 cases), the middle segment of GSV (up to
and 23.2% in patients with bilateral process. The rest, which are 10-12 cm from SFJ) were free; vein could be compressed by a
36.6% and 76.8%, respectively, needed more than 3 sessions. sensor, and anterograde or retrograde blood flow was
The need for multiple sessions may be due to the majority of registered. An incomplete ‘‘closure’’ of the GSV trunk became
patients starting treatment in the later stages of disease, with possible because of flushing foam by a blood flow from those
reflux spreading to the middle third of the calf or to the level of not diagnosed by US examination of the anterior accessory
the ankle, as well as a significant transformation of the tribu- GSV (2 cases), likewise its migration into the femoral vein
taries of the GSV. The clinical assessment and grading at the through a large incompetent perforant vein of the femoral canal
time of follow-up was performed by independent experts, that (8 cases). These patients underwent resclerotherapy in 7 to 10
is, phlebologists from our medical center. days from the point above the occlusion of the GSV.

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4 Vascular and Endovascular Surgery

Table 2. Number of Sessions Per Patient.a Table 3. Dynamics of Symptoms.

Number of Sessions One Limb, n (%) Two Limbs, n (%) Before Within 6 Months
Complaints Treatment, n (%) After Treatment, n (%)
1 12 (4.7) 0 (0)
2 26 (10.1) 0 (0) Varicose veins 314 (96.3) 8 (2.5)
3 125 (48.6) 16 (23.2) Pain 252 (77.2) 11 (3.4)
>3 94 (36.6) 53 (76.8) Itching 220 (67.5) 20(6.1)
a
Edema 204 (62.6) 17 (5.2)
Total: 1279 sessions; average: 4.2 + 0.6. Heaviness 188 (57.7) 6 (1.8)
Cramps 174 (53.4) 12 (3.7)

250

200

Number of limbs
150

100

50

0
C0 C1 C2 C3 C4 C5 C6
before treatment (395 GSV) 0 0 148 223 9 13 2
aer 6 month (382 GSV) 168 178 15 0 6 15 0

CEAP clinical grade

Figure 2. DUS data (longitudinal scan) of the terminal segment of the
GSV before (a) and a week after (b) asession of foam sclerotherapy. A,
incompetent saphenofemoral junction and retrograde blood flow (the Figure 3. The distribution of observations according to the CEAP
arrow is pointing to retrograde blood flow in the SFJ); B, total classification before and 1 year after treatment.
occlusion of the saphenofemoral junction segment t (the arrow is
pointing to echo-positive mass in the SFJ). Table 4. Distribution of the Limbs According to the Diameter of the
GSV.a
Six-Month Follow-Up Diameter Number of Limbs, % With Retrograde Flow, n (%)
After 6 months, 315 (96.6%, 382 GSV) of 326 patients had clin- 4-6 mm 14 (19.7) 1 (7.1)
ical and DUS follow-up and 11 patients were lost to follow-up. 6.1-8 mm 32 (45.1) 0
According to DUS data, the number of GSV with retrograde 8.1-10 mm 15 (21.1) 3 (20.0)
blood flow was 14 (3.7%). In 6 (6 GSV, 1.6%) patients, partial >10 mm 10 (14.1) 2 (20.0)
occlusion and reduction in the diameter of the vein were observed Abbreviation: GSV, great saphenous vein.
a
(reflux <1 second partial compression). In 5 (1.3%) cases, new Five-year follow-up patients.
varicose veins appeared; in 3 (0.8%) cases, a combination of new
not return. In 66 (93.0%) patients, there were no symptoms of
varicose veins with recanalization of previously ‘‘closed’’ GSV
varicose disease and DUS-confirmed GSV occlusion in 68
was diagnosed. The main reason for antegrade flow and reflux
(91.9%) cases. Residual varices were diagnosed in 5 (7%)
was incompetent SFJ and paratibial perforating veins. All
patients, and flow in the GSV and tributaries was noted in 6
patients with GSV reflux were additionally treated by sclerother-
cases. Table 4 shows that the number of cases with GSV and
apy (GSV was punctured in the area of maximum compressibility).
tributary flow is based on the initial GSV diameter. In 6 cases,
Clinically, GSV on palpation of a thigh area was determined
antegrade and retrograde flow in GSV (thigh level) and its
as dense, sometimes painful cord. In 2 patients (C6), open
tributaries (thigh and calf levels) were registered. Great saphe-
trophic ulcer healed within 1.5 months after the treatment (5 and
nous vein and tributary flow was caused by incompetence of
6 sessions of sclerotherapy). Subjective complaints related to
the SFJ, with reflux in the accessory saphenous vein (2 limbs,
venous disease decreased after treatment as shown in Table 3.
2.8%), reflux in the incompetent GSV trunk (2 limbs, 2.8%),
Change in the structure of CEAP clinical grades before and
and reflux in the incompetent GSV trunk and in the accessory
after treatment is shown in Figure 3, which elucidates that after
saphenous vein (1 limb, 1.4%) and the incompetence of PV of
treatment, the number of patients with early-stage disease
the femoral canal (1 limb, 1.4%). All patients with GSV and
increased and the proportion of patients C2 to C6 decreased.
tributary flow had 1 to 3 further sclerotherapy sessions.

Five-Year Follow-Up Side Effects and Complications

Of the 97 (101 GSV) patients treated in 2009, 71 (74 GSV, Table 5 lists the type and frequency of side effects of USGFS.
73.3%) had a 5-year follow-up and 26 (27 GSV) patients did The most frequent side effect was skin hyperpigmentation

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Baeshko et al
Table 5. Side Effects and Complications.
Number of Number of
Side Effect Patients, % Procedures, %
Hyperpigmentation 106 (32.5)
Transient visual disturbances 1 (0.3) 1 (0.08)
GSV thrombophlebitis or its branches 31 (9.5)
Deep vein thrombosis (latent) 1 (0.3)
Abbreviation: GSV, great saphenous vein.
along the varices (32.5%), followed by symptomatic superficial
thrombophlebitis (9.5%). One (0.08%) patient noted flickering
in the eyes and seeing phantom objects 20 to 30 minutes after
the procedure. There were no cases of DVT after USGFS of the
GSV. One left sural vein thrombosis was identified at 1-month
follow-up (after the third session of sclerotherapy). Thrombus
did not extend to the main tibial veins and was limited to
outside of the medial gastrocnemius vein trunk. Anticoagulant
drugs were not administered.
Discussion
Previous studies have demonstrated that foam sclerotherapy is
an effective and safe method for the treatment of varicose
veins, including the trunks of great and small saphenous veins
and their tributaries.8-14 Reported rates of the successful abla-
tion range from 68%15 to 100%,16 with follow-up from 1 month
to 10 years; however, interpretation of these results is difficult
because of the differences in definitions of success, the use of
surrogate markers (occlusion or narrowing of the treated vein,
resolution of reflux), differing primary outcome markers (res-
olution of symptoms, improved quality-of-life scores, recurrent
varices, ulcer healing), and the number of ultrasound-guided
foam sclerotherapy sessions needed to achieve success.
The ultimate goal of treatment is occlusion of the GSV,
which usually results in elimination of varicose vein recurrence
over the course of long-term follow-up. Effectiveness of the
USGFS is determined by the degree of occlusion of the saphe-
nous trunk. The absence of antegrade and retrograde flow and
incompressibility of saphenous trunk confirmed by ultrasound
examination indicate a successful procedure. Rasmussen et al
randomized patients with great saphenous varicose veins into 4
treatment groups: laser ablation, radiofrequency ablation, foam
sclerotherapy, and surgical stripping. At 1 year, the number of
patent GSV’s with reflux was 7 (5.8%), 6 (4.8%), 20 (16.3%),
and 4 (4.8%), respectively. Although the technical failure rate
was the highest after foam sclerotherapy, both radiofrequency
ablation and foam sclerotherapy were associated with a faster
recovery and less postoperative pain than endovenous laser
ablation and surgical stripping.17
Comparison of USGFS to other endovenous techniques
reveals similar outcomes. According to the management of
chronic vein disorders of the lower limbs, the effectiveness and
costs are compared between USGFS and endovenous laser
ablation. There is no difference in occlusion rate, AVVQ,
VCSS, or venous filling index between the 2 procedures. In
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5
the presence of saphenous incompetence and in a technical
point of view, they recommend USGFS as well as thermal
ablation (radiofrequency, laser) with grade 1A.1
In a large case series of patients treated with USGFS, Smith
found that the main factor influencing recurrent venous
reflux and recanalization was the size of the vein prior to
treatment.12 Recurrence were more likely to happen in both
GSVs and SSVs of 6 mm or greater compared to those of
5 mm diameter and below. We speculate that larger diameter
veins remain filled with blood and do not allow the foam to
completely fill the vessel lumen along its inner perimeter.
Similar results were reported by Gonzalez-Zeh et al18 Failure rate
increased from 7% in the <8 mm subgroup to 67% in the >12 mm
subgroup treated with foam. Ninety percent of success rate after
USGFS was only predicted for veins <6.5 mm. According to the
literature data,4 foam tends to be distributed around the perimeter
of the small and medium vessels only. In the veins of large dia-
meter (8 mm), foam is mixed with blood, and, according to Archi-
medes law, predominantly takes the top position in the vessel (on
the top panel). Although some authors use tumescent anesthesia
(TA) to reduce the vein diameter and limit blood flow, their results
have not demonstrated any benefit of additional TA.19-22
We describe a new protocol for sclerotherapy specifically
aimed at reducing the GSV diameter and increasing the con-
centration of foam in the femoral GSV segment. In our 6 years
of experience performing USGFS, we found that limb elevation
of 60 or more causes the vein lumen to disappear during DUS
examination. This diameter reduction improves the efficiency
of the procedure by allowing foam bubbles to line the inner
vein wall circumferentially. We also applied a calf bandage to
prevent migration of foam into the distal venous bed and we
used cooled sclerosant solution to increase spasm of the vein.
Using this protocol, we achieved a 94.5% rate of GSV occlu-
sion by ultrasound examination 1 week after sclerotherapy. In a
smaller group of patients evaluated 5 years after sclerotherapy,
91.9% of the treated GSV’s were occluded. Treatment success
could be achieved without difficulty in patients in whom the
GSV was not initially occluded for various reasons such as
undiagnosed perforators or tributaries. Our results suggest that
retrograde flow in the GSV was slightly more frequent in
patients with large diameter veins (>8 mm); however, this was
not statistically significant.
Foam sclerotherapy required 30 minutes per treatment ses-
sion, patients could walk from the room afterward, and, in most
cases, patients only took time off on the days in which treat-
ment was given. Discomfort at the time of treatment was min-
imal, and in the majority of patients, symptoms in the 2 weeks
following treatment were few, although thrombophlebitis was
seen in 9.5%. Patients main complaints were related to the
compression bandage applied after each session. Few other
problems were encountered, with skin pigmentation at
follow-up being the most frequent. Pigmentation was usually
mild and continued to resolve with the passage of time.
It was a single-center retrospective series of patients.
Patients followed up for 5 years represent only 27.9% of the
overall group, and 73.3% of these patients were inspected. This
6 Vascular and Endovascular Surgery
is a potential disadvantage, since it might lead to bias in the
overall assessment. Patients were all invited to attend at an
interval of 5 years following initial treatment, but many
defaulted. In 8.1% of cases, patients returned with residual or
recurrent varices due to recanalization of the GSV or SFJ. In the
series of patients presented here, no case of total recanalization of
the GSV was observed. There was no control group to compare
with. For comparison, only data results from various sources of
sclerotherapy with standard parameters (horizontal limb position,
sclerosant at room temperature, no calf bandaging) were used.
The venous clinical severity score was not used. The authors were
limited by the assessment of the symptoms of the disease. The
patients included in this series were predominantly women
(94%). This could be due to the fact that men are less likely to
seek medical advice when varicose veins appear. There were no
patients with superficial femoral vein valves incompetence.
This clinical series demonstrates that ultrasound-guided
foam sclerotherapy with new parameters of the technique
allows achieving a high occlusion rate of the GSV. The rates
of complication are similar to those reported for the other
endovenous treatments of varicose veins.
Conclusion
Ultrasound-guided foam sclerotherapy is an effective method
for the treatment of GSV insufficiency. Improving the tech-
nique (60 limb elevation, calf bandage, application of the
cooled solution for preparing foam sclerosant) allows us to
improve the results of the treatment of patients with GSV
incompetence.
Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with respect to
the research, authorship, and/or publication of this article.
Funding
The author(s) received no financial support for the research, author-
ship, and/or publication of this article.
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