Hrev_master
Veins and Lymphatics 2015; volume 4:4676
[page 18] [Veins and Lymphatics 2015; 4:4676]
Ultrasound-guided peri-
saphenous tumescence
infiltration improves the
outcomes of long catheter
foam sclerotherapy combined
with phlebectomy
of the varicose tributaries
Attilio Cavezzi,1 Giovanni Mosti,2
Sonia Di Paolo,3 Lorenzo Tessari,4
Fausto Campana,5 Simone Ugo Urso1
1Eurocenter Venalinfa, S. Benedetto del
Tronto (AP); 2Clinica Barbantini, Lucca;
3Clinica Stella Maris, S. Benedetto del
Tronto (AP); 4Fondazione Glauco Bassi,
Trieste; 5Vascular Medicine Unit, Cesena
Hospital, Cesena (FC), Italy
Abstract
A prospective comparative observational
study was performed to assess the short--term
efficacy and safety of the peri-saphenous infil-
tration of tumescence solution (PST) in great
saphenous vein (GSV) long catheter foam scle-
rotherapy (LCFS) combined with phlebectomy
of the varicose tributaries. Since November
2006 through November 2010 fifty-one consec-
utive patients (16 males and 35 females, mean
age 51.5 years) who underwent LCFS of GSV +
multiple phlebectomies were prospectively
enrolled, without any pre-selection criteria, in
three different groups (17 patients per group)
and reviewed as to their outcomes: i) patients
without additional PST; ii) with PST under
visual control; iii) with ultrasound-guided PST.
All procedures were performed in local anes-
thesia and an average of 7 mL [interquartile
range (IQR) 6.5-7.5] of 3% sodiumtetradecyl-
sulfate CO2+O2-based sclerosant foam was
injected in the diseased segment of GSV
(median caliber 7) (IQR 6-8) by means of a 4F
long catheter. Clinical and color-duplex ultra-
sound (CDU) follow-up was performed at reg-
ular intervals, the last of which 14 months
after the treatment.
At 14 months follow-up no varicose veins
were visible in 94%, 94% and 100% of the cases
in group I, II and III respectively. The CDU-
based outcomes were the following: 71%, 71%
and 84% GSV occlusion rate in group I, II and
III respectively; reflux was found in 5, 4 and 1
cases in group I, II and III respectively. Clinical
and CDU morphologic and hemodynamic
results were assembled and scored through an
arbitrary system. The relative statistical analy-
sis showed a significant (P<0.0001) improve-
ment of the results for patients who received
ultrasound guided PST over the other two
groups. No relevant complications were
recorded in all 51 cases.
GSV treatment by means of LCFS + phlebec-
tomy of varicose tributaries proved to be effec-
tive and safe in this prospective observational
study. The addition of ultrasound guided PST
resulted in a significant improvement of GSV
occlusion rate and of varicose vein clinical res-
olution.
Introduction
Varicose veins of the lower limbs affect
about 15% male and 25% of female population.1
Different treatment methods have been pro-
posed including surgery, endothermal ablation
and chemical ablation by means of foam scle-
rotherapy, all of them facing some degree of
recurrence in the long term.2
Ultrasound guided foam sclerotherapy
(UGFS) is performed by injecting a foamed
sclerosant agent, usually sodium-tetradecyl-
sulphate (STS) or polidocanol into the target
vessel under duplex ultrasound guidance.
UGFS has been proved effective and safe in the
treatment of great saphenous vein (GSV),
small saphenous vein, tributaries, perforators,
recurrences and venous malformations.3
Recent systematic reviews show an overall
inferiority, in terms of venous occlusion rate,
of UGFS in comparison to other endovenous
techniques, such as laser and radiofrequency,
or to surgery.4-8 For UGFS most clinical series
show an increased recanalization rate for larg-
er saphenous diameters,9-11 which is likely due
to the higher amount of blood, hence to a high-
er dilution and especially in the deactivation of
sclerosant drug by blood protein binding.12-16
The peri-saphenous infiltration of tumes-
cence solution (PST) is performed in endove-
nous thermal ablation to reduce the venous
diameter, thus resulting in a smaller amount
of blood within the target vein, to reduce/abol-
ish procedure-related pain and protect the
peri-saphenous tissues.17,18
Aim of the study was to assess if PST, mini-
mizing the saphenous caliber prior to foam
delivery, and reducing venous blood content
and blood inflow from tributaries and perfora-
tors into the saphenous stem, may improve the
outcome as regards occlusion rate and vari-
cose vein clinical resolution.
Materials and Methods
Since November 2006 through November
2010, fifty-one consecutive patients, 16 males
and 35 females, with mean age of 52.5 +/- 6.9
(range 48-72) years were enrolled in the study
on an intention-to-treat basis. All patients
were submitted to long catheter foam scle-
rotherapy (LCFS) of GSV + phlebectomy of the
varicose tributaries in local anesthesia.
Inclusion criteria were primary varicose
veins related to GSV incompetence (reflux >1
s), in absence of any previous active treat-
ment. Exclusion criteria were: pregnancy,
acute deep or superficial vein thrombosis,
severe peripheral arterial occlusive disease
(e.g. basal ankle-brachial index below 0.6),
symptomatic patent foramen ovale, cardiac or
renal failure, immobility, relevant throm-
bophilia (e.g. deficit of AT III, protein C and S),
allergy to STS.
All patients underwent clinical and color-
duplex ultrasound (CDU) (7.5-13 MHz linear
probe, Toshiba SSA-340 or GE Vivid 3) investi-
gation in standing position, with measure-
ment of GSV caliber 3 cm below the terminal
valve and at mid thigh, excluding any saccular
dilation from measurements. The final GSV
diameter was calculated as the mean of the
two measurements above. Sapheno-femoral
junction (SFJ) and GSV were assessed as to
previously published International Union of
Phlebology (UIP) recommendations and proto-
cols.19-21 Patients were fully informed on the
subsequent procedures and gave their consent
to be enrolled into the study. The patients were
divided in three different groups (17 patients
each group) in a consecutive sequence; each
patient had one limb operated on.
All patients were operated on an outpatient
basis by one of the authors (CA) and the whole
procedure was performed in local anesthesia
(buffered mepivacaine 0.125%, 250 mL per
procedure as average), with pre-operative oral
administration of 0.8 mg of delorazepam, with
Correspondence: Attilio Cavezzi, Eurocenter
Venalinfa, viale dello Sport 14, 63074 S.
Benedetto del Tronto (AP), Italy.
E-mail: info@cavezzi.it
Key words: sclerotherapy, ultrasound-guided scle-
rotherapy, long-catheter-foam-sclerotherapy, peri-
saphenous tumescence infiltration.
Acknowledgements: thanks to Paul Thibault, Ken
Myers, and Kurosh Parsi for having shared their
studies and knowledge on tumescence infiltra-
tion in foam sclerotherapy with us.
Received for publication: 22 August 2014.
Revision received: 24 November 2014.
Accepted for publication: 29 January 2015.
This work is licensed under a Creative Commons
Attribution 3.0 License (by-nc 3.0).
©Copyright A. Cavezzi et al., 2015
Licensee PAGEPress, Italy
Veins and Lymphatics 2015; 4:4676
doi:10.4081/vl.2015.4676
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[Veins and Lymphatics 2015; 4:4676] [page 19]
elevated limbs (Trendelemburg position).
Sclerosant foam was prepared according to
Tessari method, mixing STS 3% (Fibrovein
3%®; STD Pharmaceutical Products, Hereford,
UK) with CO2 70% + O2 30% one-to-four ratio,
in silicon-free syringes.
The incompetent segment of GSV trunk and
the varicose veins were marked on the skin
pre-operatively. The distal part of the incompe-
tent GSV trunk was hooked through a 3-4 mm
incision, disconnected and ligated, and a 4F
catheter was advanced inside the proximal
GSV trunk with the tip positioned about 5 cm
below the TV of SFJ.
One group of patients (group I: NO TUM)
did not receive any tumescence solution infil-
tration. In a second group of patients (group II:
VISUAL TUM) PST was delivered under visual
control following the GSV marks on the skin. In
the third group of patients (group III: UG TUM)
PST was delivered under ultrasound guidance,
strictly within the saphenous compartment.
Tumescence solution was made up with 5
mL of 2% mepivicaine, 10 mg of ethylephrine
hydrochloride, 5 mL of sodium bicarbonate 10
meq/10 mL and 250 mL of saline solution. The
tumescence solution amount was decided as to
the dose to fully collapse GSV trunk for the
whole targeted length.
While performing tumescence infiltration,
GSV trunk was continuously flushed with
saline solution, through the in situ catheter, in
order to minimize blood content.
After PST completion, 1 mL of 3% STS foam
every 5 cm was delivered within the incompe-
tent tract of GSV while retrieving the catheter
(Figure 1).
Simultaneously to LCFS procedure, hook
phlebectomies through mini-incisions (1-2
mm) were performed to remove the visible
varicose tributaries. Phlebectomy was inter-
rupted in all cases some ten centimetres above
the most distal visible varicose tract.
Post-operative compression consisted in 35
mmHg stocking (Struva 35®; Medi GmbH,
Bayreuth, Germany) + pads along the treated
areas, which were worn 24 h a day for 7 days.
Subsequently medical elastic stocking class I
(18-21 mmHg) was prescribed for 40-60 days
in daytime. Ambulation was allowed 30-60 min
after the treatment and the patients were dis-
charged 1-2 h afterwards. One single injection
of low molecular weight heparin at prophylac-
tic dose was administered pre-operatively.
During the follow-up period no additional ses-
sions of UGFS were performed after the origi-
nal procedure.
Clinical and full limb CDU follow up was per-
formed by one author (CA) after 40 days (and
earlier in case of alerting symptoms and signs)
and at sixth month, and by two independent
observers (USU and CF) at 12-15 months
[median value 14.4 months, interquartile
range (IQR) 13-15.5 for all groups] after the
treatment, in order to assess the technical suc-
cess of GSV sclerotherapy and to check for any
side effects/complications (primarily of throm-
botic nature during the early follow-up).
Any possible residual/recurrent visible/pal-
pable varicose vein in the treated area was
reported. As to GSV assessment, CDU investi-
gation was performed in standing position and
with 5-10 cm threshold color/Doppler flow
velocity setting, in order to pick up also tiny
refluxes. Complete occlusion was defined as
total incompressibility of GSV trunk and
absence of color/Doppler flow in more than
80% of the length of the treated segment.
Partial recanalization was defined as partial
compressibility of the treated segment and/or
an occlusion below 80% of the intended length
treated. A fully recanalized vein had a com-
pletely compressible lumen in more than 20%
of the treated segment. When GSV was partial-
ly or completely recanalized, the inner residual
lumen was measured and an antegrade or ret-
rograde flow was highlighted in the targeted
GSV segment (Figure 2).
In order to get an overall evaluation of the
final results and of the possible differences
among the three groups, morphological and
hemodynamic CDU findings, together with
clinical results, were taken in consideration
and plotted according to an arbitrary scoring
system as follows: occlusion was scored as 0
point, 1 point was assigned to recanalization
and 1 point each for visible varicose veins, for
recanalization larger that 1 mm and for venous
reflux above 1 s was added as well.
Statistical analysis
The data were submitted to statistical analy-
sis. Kruskall-Wallis test was used to analyze
vein diameter and foam dosage; Mann-
Whitney test was used for tumescence solution
amount. Friedman test was used to analyze the
clinical + CDU outcomes.
The software Prism 5 (GraphPad; San
Diego, CA, USA) was used for statistical analy-
sis and to create the graphs.
Results
The three different groups didn’t show any
significant difference as regards demographic
and duplex data (see below); Figure 3 shows
the details of the statistical analysis of GSV
diameter variation in the three groups.
Group I (NO TUM): patients who underwent
LCFS + phlebectomy without additional PST (4
males and 13 females); distribution of C of
Figure 1. Sclerosant foam delivery while retrieving the long
catheter inside great saphenous vein.
Figure 2. Color-Duplex ultrasound follow-up shows retrograde
flow in a previously treated great saphenous vein (GSV) stem,
with an inner diameter of 1.2 mm.
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Clinical-Etiology-Anatomy-Pathophysiology
(CEAP) classification was as follows: C2 13
patients; C3 2 patients; C4 1 patient; C5 1
patient; mean GSV caliber before the treat-
ment was 7.23 [standard deviation (SD) 1.29]
mm. Group II (VISUAL TUM) : patients with
additional PST along the marked path, under
visual control (6 males and 11 females); distri-
bution of C of CEAP was as follows: C2 11
patients; C3 5 patients; C4 1 patient. Mean GSV
caliber before the treatment was 7.35 (SD
1.74) mm. Group III (UG TUM): patients with
ultrasound-guided PST (6 males and 11
females); distribution of C of CEAP was as fol-
lows: C2 14 patients; C3 3 patients; mean GSV
caliber before the treatment was 7.32 (SD
1.55) mm.
Median dose of injected sclerosant foam was
7 mL (IQR 6.25-7 in group I; 6.5-7.5 in group II;
6.50-8 in group III) without any statistical dif-
ferences between groups (Figure 4A).
Median dose of injected tumescence solu-
tion in groups II and III was 150 mL (IQR 140-
160 in group II; 142.5-150 in group III, without
any statistically significant difference (Figure
4B). Concerning the clinical and CDU follow-
up results, data differentiated along the follow-
up in favor of group III.
At first month follow-up all 51 patients
showed no varicose veins and a fully obliterat-
ed GSV trunk. At the second clinical and CDU
check-up (6 months) group I and group II had
one patient with recanalized and refluxing
GSV, whereas group III had one recanalized
GSV with antegrade flow. No recurrent/resid-
ual varicose veins were evident at the clinical
observation. At the last clinical and CDU fol-
low-up (14 months after the operation) the
three groups showed different findings
(Figure 5). In patients of group I one patient
(6%) presented clinically visible recurrent
varicose veins, although of small caliber (3-4
mm). At CDU control 12 GSVs (70.6%) were
occluded, five limbs (29.4%) had a partially
recanalized GSV trunk with reflux exceeding
one second. The mean diameter of the residual
patent GSVs was 2.9 mm.
In patients of group II two patients (11.8%)
had recurrent varicose veins and at CDU con-
trol 12 GSVs (71%) were occluded, one patient
(5.9%) had partially recanalized GSV trunk
with antegrade flow and 4 patients (23.1%)
showed partially recanalized GSV trunk with
retrograde flow. The average residual caliber
was 3.0 mm. In patients of group III (UG TUM)
there was no clinical recurrence in all 17
patients. CDU investigation highlighted full
occlusion in 14 GSVs (82.4%), partial recanal-
ization with antegrade flow in two patients
(11.7%) and partial recanalization with short
duration (below one second) reflux in one
patient (5.9%). The average residual caliber
was 0.9 mm.
According to our scoring system concerning
the clinical and duplex post-treatment find-
ings, no difference was recorded between
group I and II (no tumescence vs visual tumes-
cence), while a statistically significant
(P<0.0001) improvement of the outcomes was
recorded in group III [ultrasound-guided
thrombin injection (UGTI)] in comparison to
group I and group II (Figure 6).
No relevant complications were recorded in
all 51 cases. More specifically patients did not
report any neurologic/pulmonary/cardiac
symptoms intraoperatively, or in the following
hours or days; no deep or superficial vein
thrombosis was detected at clinical and CDU
follow-up. Concerning side effects, two
patients reported skin induration along a few
phlebectomy sites.
Discussion
GSV treatment is still based on stripping in
most countries, but endovenous thermal abla-
tive treatments have become more and more
popular worldwide. UGFS on one side, and
hook-phlebectomy on the other side represent
mini-invasive treatments, which have under-
gone a growing diffusion as well.22-24
In a recent meta-analysis, on the effective-
ness of endovenous therapies for lower limb
varices found, after 3 years, the estimated
pooled success rates for stripping, UGFS,
radiofrequency ablation, and laser therapy was
78%, 77%, 84% and 94% respectively.25 Also in
Rasmussen’s randomized clinical trial at one
year 5.8%, 4.8%, 16.3% and 4.8% of the GSVs
were patent and refluxing in the laser,
radiofrequency, foam and stripping groups
respectively (P<0.001).
Various observational studies26-28 have clear-
ly showed the negative impact of larger saphe-
nous caliber on the final outcome of UGFS.
Gonzalez Zeh29 reported 93% vs 33% oblitera-
tion rate for GSV trunk below 8mm and above
12 mm respectively after UGFS.
Despite the good short/mid-term results of
foam sclerotherapy, this method is character-
ized by objective limitations when dealing with
large-caliber veins, for which higher doses of
sclerosant foam are required, which may
decrease the overall safety of UGFS.30
Actually there is strong evidence that blood
Figure 3. Comparative statistical analysis of the pre-treatment
great saphenous vein diameter in the three groups.
Figure 4. A) Comparative statistical analysis of the injected dose
of sclerosant foam in the three groups; B) comparative statistical
analysis of the injected dose of tumescence solution in groups II
and III.
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[Veins and Lymphatics 2015; 4:4676] [page 21]
components denaturate/inactivate sclerosant
drugs,12-16 mainly through protein binding.
Stagnating blood in the saphenous trunk
prior to sclerosant foam injection is propor-
tional to vein size and it objectively
dilutes/inactivates sclerosant drug, notwith-
standing the clearing effect of foam in proxim-
ity of the injected site and for the first sec-
onds/minutes. Similarly inflow of blood
drainage within GSV stem, via tributaries and
perforators, contribute to clear foam away from
the targeted segment and especially this inflow
brings new aliquots of fresh blood, which neg-
atively interferes with sclerothrombus forma-
tion. Compression by means of bandages,
stockings with or without pads, has been pro-
posed in liquid and foam sclerotherapy, in
order to address the problems as to above, with
uncertain results.3 Elevation of the limb prior
to foam injection has been advocated since the
early introduction of UGFS,31 with the aim to
reduce vein size (hence blood content) and to
improve UGFS efficacy/safety. Milleret32
showed improved results of foam sclerotherapy
by means of long catheter usage and Esmarck’s
bandage application to minimize blood in GSV
prior to foam delivery.
In 2006 Paul Thibault as first proposed the
injection of a tumescent solution around the
vein after its injection with sclerosant foam,
and he reported lower visual disturbance inci-
dence and some outcome improvement.33 In
the latest years further publications on PST34-37
have confirmed the possible role of this com-
plementary technique in foam sclerotherapy,
especially when treating larger veins which
present a higher rate of recanalization in the
medium and long-term follow up.
For this reason, since 2000 the usage of a
long catheter as an alternative to UGFS was
highlighted.38 Subsequently other authors
reported interesting results with LCFS.39-44 In
fact the use of a long catheter on one side may
allow a more targeted and homogenous distri-
bution of the sclerosant foam; on the other
side the placement of a long catheter within
the saphenous stem allows fluid tumescence
infiltration within the saphenous compart-
ment to minimize saphenous caliber prior to
foam delivery.
The peri-saphenous tumescence infiltration
is routinely used in laser treatment and
radiofrequency ablation, in order to provide
anesthesia, compress the veins and disperse
the generated heat.
In long catheter foam sclerotherapy the peri-
saphenous tumescence infiltration is effective
in decreasing significantly the caliber of the
vein and the blood inflow from the tributary
veins, aiming at achieving the so called empty
vein technique, which was postulated by
George Fegan decades ago.45 The injected vol-
ume of sclerosant foam was about 1 mL per 5
cm length of treated GSV, which contributed to
standardize the procedure and to fill adequate-
ly catheter and the targeted vein segment. Just
in order to get a longer and more consistent
vasoconstriction of the target vein, in our
experience the tumescence solution included
saline solution and a buffered anesthetic drug
combined with ethylephrine, which may
induce a longer saphenous spasm in compari-
son to the infusion of saline solution alone.
Our data clearly show that when tumes-
cence infiltration in the saphenous compart-
ment is performed under duplex guidance,
patients may achieve a better GSV occlusion
rate and a lower clinical recurrence rate
(P<0.0001), when compared both to patients
without tumescence and to patients submitted
to tumescence under visual control. The obser-
vational nature of our study, which was based
on limited number of patients per group, pre-
sented a statistical power below 80%, but
objectively the patients submitted to UG TUM
had statistically significantly better duplex and
clinical results over the patients of the other
two groups.
In fact ultrasound guided infiltration allows
a homogeneous distribution of the tumes-
cence solution within the saphenous compart-
ment, with a greater reduction of the vein cal-
iber and likely with a lower blood flow from the
inlets of the tributary veins and perforators.
Interestingly the outcomes in patients with-
out any tumescence and with tumescence
infiltration without duplex guidance were very
similar; this fact confirms that tumescence
must be precisely injected into the intravenous
compartment to be effective.
In a randomized clinical trial Devereux et
al.46 recently showed no benefit from PST on
LCFS. Nevertheless in this study unfortunately
adrenaline or another spasm-inducing drug
was not used in the tumescence solution,
which may decrease the effectiveness of this
complementary procedure. In addition the pub-
lished pictures in the article above show
tumescence solution injected intra- and extra-
saphenous compartment, hence Devereux’s
results could interestingly mimic our group II
results. Furthermore eight out of 50 patients
(more precisely 20% in the non-tumescence
group and 8% in the tumescence group) were
lost to follow-up, which objectively represents a
limitation of the statistical analysis of the
study.
Figure 5. Color-Duplex ultrasound follow-up at 14 months of the
three groups.
Figure 6. Comparative statistical analysis of the color-Duplex
ultrasound results at 14 months follow-up in the three groups.
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The overall safety of LCFS has been proved
in literature and in our experience, which well
compares with the outcomes of the other ther-
mal ablation techniques. Efficacy of LCFS with
ultrasound guided PST may reach levels of
other thermal ablative techniques, even in
large caliber veins, while using quite low vol-
umes of sclerosant foam. These positive fea-
tures may potentially lead to overcome the
main limitations and critical issues of UGFS.
Finally, compared to laser and radiofrequen-
cy ablation (RF), this procedure is quicker as
both the time to perform UGTI (lower doses
are needed) and the time to inject foam
through the catheter are shorter than the cor-
responding times of the thermoablative proce-
dures. Finally it is of great importance to high-
light how the costs of LCFS are significantly
lower than the costs of RF and laser.
A limitation of the study is represented by
the small number of the enrolled patients but
this was designed as a pilot, observational
study and no randomization was planned.
However the consecutive prospective feature
of the trial and the significant diagnostic and
therapeutic homogeneity of the three groups
reinforce the value of our data.
More consistent data need to be collected by
larger trials with longer follow-up to provide
adequate evidence in favor of ultrasound guid-
ed PST in foam sclerotherapy. However our
experience with this procedure is providing
more and more robust data, which highlight a
promising profile of efficacy and safety for
LCFS with additional ultrasound guided
tumescence infiltration.
Conclusions
GSV treatment by means of LCFS + phlebec-
tomy of varicose tributaries proved to be effec-
tive and safe in this prospective observational
study at short/mid-term clinical and CDU-
based follow-up. The addition of ultrasound
guided PST resulted in a statistically signifi-
cant improvement of GSV occlusion rate and of
varicose vein clinical resolution. Furthermore
a significant improvement of the overall mor-
phologic and hemodynamic features of the
treated veins was reached as well.
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