Original article
Endovenous laser ablation and foam sclerotherapy for varicose
veins: does the presence of perforating vein insufficiency affect
the treatment outcome?
Mert Köroğlu1, Hüseyin Naim Eriş1, Aykut Recep Aktaş1, Mustafa Kayan1, Ahmet Yeşildağ1,
Meltem Çetin1, Cem Parlak2, Cemil Gürses3 and Okan Akhan4
1
Süleyman Demirel University, Faculty of Medicine, Department of Radiology, Isparta; 2Antalya Education and Research Hospital,
Department of Radiation Oncology, Antalya; 3Antalya Education and Research Hospital, Department of Radiology, Antalya; 4Hacettepe
University, Faculty of Medicine, Department of Radiology, Ankara, Turkey
Correspondence to: Mert Köroğlu. Email: [email protected]
Abstract
Background: Superficial venous insufficiency is a common problem associated with varicose veins.
Endovenous laser ablation (EVLA) and concomitant ultrasound (US)-guided foam sclerotherapy are recent
treatment methods alternative to surgery in the treatment of superficial venous insufficiency.
Purpose: To compare the effectiveness of EVLA and concomitant US-guided foam sclerotherapy
prospectively in two different subgroups of the disease (isolated truncal vs. truncal with perforating vein
insufficiency).
Material and Methods: The study was approved by the institutional review board. Fifty-five patients with
symptomatic saphenous vein insufficiency and varicose veins were included in the study. Seventy-three
EVLA and concomitant foam sclerotherapy were performed for 60 lower extremities. To determine the
severity of the venous disease, Venous Clinical Severity Score (VCSS) and Visual Analogue Scale (VAS) were
carried out before and 6 months after the treatment. Patients were followed up clinically and with Doppler
ultrasonography for 6 months after the procedures.
Results: At the sixth month of the follow-up; the total occlusion rate for the saphenous veins was 98.64%
(72/73), and re-canalization rate was 1.36% (1/73). The total occlusion rate for the perforating veins was 75%
(18/24), re-canalization rate was 25% (6/24). There was no notable major complication. VCSS and VAS
scores were decreased significantly following the treatment ( p , 0.05). The patients who had isolated
saphenous vein insufficiency (Group I: 36/60) and those who had saphenous and perforating vein reflux
(Group II: 24/60) were compared. VAS scores were more prominently decreased after the treatment in the
isolated saphenous vein insufficiency group ( p , 0.05). VCSS were also decreased more prominently in
Group I when compared to Group II.
Conclusion: EVLA and concomitant US-guided foam sclerotherapy are effective, safe, and minimally
invasive treatment options, yielding good cosmetic and clinical results in both isolated truncal and truncal
with perforating vein insufficiency groups. However, clinical results and satisfaction of the patients were
remarkably superior in cases with isolated truncal vein insufficiency compared to truncal and perforating
vein insufficiency.
Keywords: Vascular, interventional, ultrasound Doppler, ablation procedures, laser, varices
Submitted August 12, 2010; accepted for publication December 7, 2010
Superficial venous insufficiency and varicose veins are quite superficial venous insufficiency is varicose veins. It is not
common, occurring in approximately one-third of the adult only a cosmetic problem since many patients experience
population (1). The most common manifestation of debilitating symptoms ranging from lower extremity pain,
Acta Radiologica 2011; 52: 278– 284. DOI: 10.1258/ar.2010.100356
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Endovenous laser ablation and foam sclerotherapy for varicose veins 279
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swelling, heaviness, warmth, itching, cramping, and muscle analogue scales (VAS) were utilized before and after the
fatigue to inflammatory dermatitis and venous stasis ulcers (2). treatment in the current study. VCSS is a useful tool for
Valve failure is the most common cause of symptomatic assessing venous outcome and should be used in clinical
venous pathology (3). Seventy percent of varicose veins studies to quantify venous outcome (9 – 11). A detailed
are attributable to incompetence at the saphenofemoral table for VCSS have been published by Rutherford et al.
junction (SFJ) with reflux along the greater saphenous vein (11). All patients scored the severity of their symptoms
(GSV) (3, 4). Venous insufficiency can also affect the lesser with a VAS (range 0 –10, 0 ¼ no symptoms, 10 ¼ worst
saphenous vein (LSV), perforating veins, pelvic and possible symptoms) before the procedure and in the
gonadal veins. follow-up period. Color photography of the varicosities in
The conventional treatment of saphenofemoral venous the legs, which is extremely valuable in the documentation
incompetence is surgery: ligation and GSV stripping (3). of the response to the therapy, is taken before the treatment
One-third of the patients will develop further varicose and in the follow-up.
veins after such treatment (5, 6). Surgery has some disad-
vantages such as general anesthesia, longer hospital stay,
and more complications. New treatment methods are Preprocedural Doppler US technique
needed to overcome these disadvantages. Recently endove- A systematic Doppler US examination was performed by
nous laser ablation (EVLA) and ultrasound (US)-guided two interventional radiologists (MK, HNE). This is the
foam sclerotherapy have revolutionized the treatment of most important step for correct CEAP classification,
superficial venous insufficiency and varicose veins (2, 7). decision-making, and treatment planning (12). The study
EVLA has been reported to be a safe and effective method was performed vith a Toshiba SSA-770A/80 Aplio Doppler
in eliminating the GSV, the LSV, and even perforator veins device (Toshiba Medical Systems Corporation, Tokyo,
from the venous circulation, with faster recovery and Japan) by using a 7.5 MHz multifrequency linear transducer.
better cosmetic results than stripping (5). Relative simplicity The diameters of the great and lesser saphenous veins 3 cm
and high rate of patient satisfaction have made these pro- caudal to SFJ and SPJ were noted. Inability to demonstrate
cedures increasingly popular (8). According to our previous reflux in the supine position did not exclude clinically sig-
observations most of the patients treated with EVLA and nificant venous insufficiency. The Doppler US examination
foam sclerotherapy are satisfied with the effectiveness of for reflux was performed in the upright and leg slightly
the therapy, nevertheless some groups of patients have externally rotated position. Reflux was assessed by looking
more benefit when compared to the others. The aim of for retrograde flow after the Valsalva maneuver or calf aug-
this study was to analyze if there was a difference mentation. Deep, superficial venous systems and their tribu-
between patients with isolated truncal and truncal with per- taries along with the perforating veins were examined
forating vein insufficiency with regard to EVLA and conco- thoroughly for the presence of reflux. Reflux was defined
mitant US-guided foam sclerotherapy efficacy. as reversal of flow lasting at least 0.5 seconds (3, 12).
Perforating vein insufficiencies in both legs and thigh were
also noted. The source and level of the venous reflux and
sonographic distribution of varicose veins were all recorded.
Material and Methods
This prospective study was performed in an Interventional
Radiology Department of a University Hospital between Informed consent
September 2008 and January 2010. The institutional review After detailed explanation of the disease, treatment options,
board approved the study. Fifty-five patients (30 men, 25 and the risks; a written informed consent was signed by
women) with symptomatic saphenous vein insufficiency both the patient and the doctor.
were included in the study. Age range was between 17– 70
years (mean 44.6 + 13.4). All the patients had symptomatic
varicose veins. After the clinical examination, all patients Inclusion and exclusion criteria
underwent a lower extremity Doppler ultrasonography Patients with symptomatic saphenous vein insufficiency
(US) examination. without any contraindications for the treatment were
Fifty-five patients and 60 lower extremities were treated. included in the study.
Five patients had bilateral treatment. Seventy-three EVLA Exclusion criteria were concomitant peripheral arterial
and concomitant US-guided foam sclerotherapy were per- disease, DVT, pregnancy, breast-feeding, inability to ambu-
formed in 60 lower extremities. All patients were classified late, and poor health status in general.
according to the clinical, etiologic, anatomic, pathophysiolo-
gic (CEAP) classification. CEAP has been developed to
allow uniform diagnosis and comparison of patient popu- Treatment
lations (5, 9). However, the CEAP clinical classification is There were two aims of the treatment as follows:
not valuable in determining the outcome measures due to
its nature of being only a 7-point score, to some of its (1) To remove the saphenous vein from the circulation
static components (C4, C5), and to its low sensitivity to (EVLA for truncal veins);
demonstrate responses following therapeutic measures (10). (2) To remove varicose veins from their sources of venous
Therefore, venous clinical severity score (VCSS) and visual hypertension (mostly by US-guided foam sclerotherapy).
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280 M Köroğlu et al.
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Endovenous laser ablation (EVLA) generator in Joules) were noted. From this information, the
The patient’s ipsilateral hip was externally rotated, and the energy density (in J/cm) was calculated. Our preferred
lower extremity was prepared and draped in a sterile means of thermal ablation was to use a laser device deliver-
fashion. US-guided EVLA of the truncal veins in conjunc- ing energy of approximately 100 J/cm to the treated vein.
tion with US-guided foam sclerotherapy of varicose and
perforating veins were performed. Ultrasound was used to Sclerotherapy technique
guide the puncture of the GSV, for the placement of the
ablation catheter, and to confirm the position of the tip of Ultrasound guidance is also very important for the foam
the laser probe, which should optimally be placed approxi- sclerotherapy. It shows spread of echogenic foam into the
mately 2 cm inferior to the SFJ. It also guided the adminis- varicose and perforating veins during the injection, and
tration of tumescent anesthesia around the truncal veins. identifies remaining segments that are unfilled and still
Access site for the truncal veins was selected as caudal as require treatment. Interventionalist can also spare the deep
possible. Local anesthesia was delivered at the access site. veins from the sclerosant with the ultrasound guidance.
The truncal vein (GSV or LSV) was accessed by a Polydocanol has a long history of safety and efficacy (3, 5,
0.021-inch micropuncture set (Micropuncture introducer 13 –15). Polydocanol (1 –3%) is mixed with air to form a
set, Cook Medical Incorporated, Bloomington, IN, USA) foam sclerosant that is directly injected into varicosities
under US guidance. Following the entry of micropuncture and perforating veins. A sclerosing solution was mixed
set, a 0.035-inch, 3-mm J guide wire was advanced into into foam (Tessari method) with air via two syringes and
the vein. A laser sheath was placed over the 0.035-inch a 3-way stopcock (13). The dilution of sclerosant to air
guide wire. A laser kit containing a 5-French, 70-cm was 1:2 and approximately 4– 8 mL of foam was used.
sheath having calibrated markings useful during the laser Foam push the blood components aside to achieve greater
pullback, and laser fiber was utilized. wall contact and this allows for a smaller volume of sclero-
Tumescent anesthesia was always administered from the sant achieving improved efficacy compared to liquid
access site to the SFJ or SPJ. A mixture of 500 mL of sclerotherapy.
normal saline, 20 mL of 2% prilocaine, 20 mL of 8.4%
sodium bicarbonate and 0.5 mg of adrenaline was prepared,
After the treatment
and injected in sufficient amounts into the tissues along the
entire length of the venous segment to be treated. Lower extremity was wrapped with an elastic compression
Tumescent anesthesia was not just for pain relief but also bandage just after the treatment. The patient was instructed
to decrease the risk of injury to the surrounding tissues about activity level, pain control, the use of a grade II com-
such as the skin and nerves. It also helps compressing the pression stocking, and follow-up. The patients were encour-
vein about the laser probe, improving results, and reduces aged to ambulate following the procedure. We advised
intravascular blood for non-specific coagulation. Whenever patients to wear compression bandage for 24 hours and
needed, intravenous sedation was accomplished with mida- compression stocking for one week.
zolam and fentanyl after the placement of guide wire.
EVLA is a very effective technique for treating superficial
Follow-up
venous insufficiency and varicose veins, especially those
originating from the truncal veins (GSV and LSV). All patients were followed up both clinically and radiologi-
Catheter-directed endovenous laser probe releases thermal cally with Doppler US on the second day, second week,
energy to the blood and venous wall, leading to intimal first, third and sixth months of the administration of the
injury and eventually to the occlusion of the treated vein. treatment. The superficial venous system, varicose veins,
The shrinkage of the vein is a gradual process where endo- perforators and deep veins were routinely assessed during
thelial damage, focal coagulative necrosis, thrombotic occlu- the follow-up. The diameters of GSV and LSV 3 cm caudal
sion, and shrinkage of the vein lead to resorption of the vein to SFJ and SPJ were noted. Any complication detected was
over several months. noted and grouped as minor and major. We defined a
A 980 nm diode laser (ELVeSTM Endolaser Vein System major complication as one that required an additional inva-
diode laser Ceralas D25-Biolitec AG, Jena, Germany) was sive procedure, prolonged hospital stay, or resulted in sig-
used. The laser fiber was advanced through the laser nificant morbidity or mortality. At the sixth month
sheath. The laser fiber tip should project approximately follow-up, VCSS and VAS were repeated. No additional
2 cm beyond the tip of the sheath. The distal most tip of treatment was applied during the follow-up.
the laser fiber was approximately 2 cm caudal to the SFJ
or SPJ. The laser fiber was then connected to the laser
source. Everyone in the room (the patient and staff ) put Statistical analysis
on laser protective eyewear. Power was usually set All statistical analyses were carried out by using SPSS
between 10 and 15 W. The energy was administrated endo- (Statistical Package for the Social Sciences, IBM
venously in a pulsed fashion. The fiber pullback rate was Corporation, Somers, NY, USA) version 15.0 package
10 mm in every 6– 8 seconds. The length of the vein program. The mean difference of measurements between
treated (measured by the markings on the laser sheath in groups was examined with Student t test for parametric
cm) and the total energy used (recorded by the laser conditions, and with Mann-Whitney U test for
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Endovenous laser ablation and foam sclerotherapy for varicose veins 281
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non-parametric conditions. P , 0.05 was considered as EVLA and foam sclerotherapy were done in 24 extremi-
statistically significant. ties with perforating vein insufficiency. Total perforating
vein occlusion were observed in 18 (75%) of those extremi-
ties, and venous insufficiency were detectable in perforating
Results veins of six (25%) extremities on the sixth month of
follow-up.
Of the 60 limbs classified according to the CEAP, 1 limb was
Mean value of VCSS before and 6 months after the treat-
C1 (1.7%), 21 limbs were C2 (35%), 23 limbs were C3 (38.3%),
ment were 7.01 + 2.76 and 2.48 + 1.49, respectively. This
10 limbs were C4 (16.7%), five limbs were C5 (8.3%).
decrease in the mean VCSS was statistically significant
Doppler US examination before the treatment revealed
( p , 0.05, paired-samples t test) (Fig. 2a). Mean VAS score
venous insufficiency along the SFJ and GSV in 58 extremi-
in 55 patients before and 6 months after the treatment
ties, and along SPJ and LSV in 15 extremities. No deep
were 7.51 + 1.3 and 2.36 + 1.84, respectively. This decrease
venous insufficiency and obstruction was notable. Venous
in the VAS score was statistically significant ( p , 0.05)
insufficiency were detected in Hunter perforating vein of
(Fig. 2b).
three (5%) extremities, Dodd’s perforating vein in two
The difference of VAS scores before the treatment and at
(3.33%) extremities, and Cockett perforating vein in 15
the sixth month follow-up was calculated for each patient.
(25%) extremities. In four (6.66%) extremities, combined
Mean of this difference in VAS scores was 6.22 + 1.45 in iso-
venous insufficiency of at least two perforating veins were
lated saphenous vein insufficiency group (Group I) and
detected. While superficial venous insufficiency was
3.54 + 1.32 in patients with perforating vein insufficiency
observed in only 36 (60%) extremities, both superficial and
along with saphenous insufficiency (Group II). The decrease
perforating vein insufficiency were detected in 24 (40%)
in VAS scores were significantly more prominent in Group I
extremities. Of the 73 EVLA procedures, it was delivered
than Group II ( p , 0.05, Mann-Whitney U) (Fig. 3a).
for only GSV in 45 extremities, for only LSV in two extremi-
The difference of VCSS values before the treatment and at
ties, and for both GSV and LSV in 13 extremities. The diam-
the sixth month of follow-up was also calculated, and mean
eters of saphenous veins treated with EVLA varied between
change in VCSS values was 4.72 + 1.48 in group I, and
3.5 –15 mm (mean 8.45 + 2.4). The length of EVLA treated
4.25 + 1.39 in group II. Although the decrease in VCSS
saphenous veins were 6 – 70 cm (mean 41.3 + 16.9).
values was more prominent in isolated saphenous vein
Depending on the length, diameter, and depth of the saphe-
insufficiency group, this difference was not statistically sig-
nous vein, totally 613 –7826 joule (mean 4218 + 1978 J)
nificant (Fig. 3b).
laser energy was applied. Energy density of 68 – 128 joule
All patients had remarkable recovery of their symptoms
laser energy per cm of saphenous vein (mean 100.2 +14.3
and clinical findings along with excellent cosmetic results
J/cm) was applied.
(Fig. 4).
Ecchymoses and tenderness to a certain degree were
noticed on the second day of the follow-up in 58.3% of extre-
mities (35/60). These findings totally disappeared in the
second week follow-up. Local superficial thrombophlebitis Discussion
rose in two extremities (3.3%) due to the thrombosis of var- Superficial venous insufficiency is a common and under-
icose veins, and both were treated with antibiotics only. No diagnosed problem that requires a thorough knowledge of
other complications were developed. Re-canalization was the venous anatomy and pathophysiology of the varicose
recorded in only one (1.36%) saphenous vein (GSV, in the veins (2 –4).
second week of follow-up) out of 73 treated with EVLA. It is the result of venous hypertension which is mostly
Total occlusion of 72 (98.64%) saphenous veins was detected caused by venous valvular incompetence (5). An optimal
on the sixth month of follow-up. The diameter of EVLA treatment plan requires accurate diagnosis and mapping
treated saphenous veins were in the range of 2.1 –6.8 mm of the source of reflux in all symptomatic varicosities.
(mean 3.78 + 1.07 mm) on the sixth month of follow-up. Doppler US has evolved as the key imaging modality for
The decrease in the diameter of saphenous veins compared diagnosis and mapping of varicose veins and has become
to the pre-treatment values were statistically significant an integral part of the management. It also has an important
( p , 0.05, paired-samples t test) (Fig. 1). role in guiding therapy and in follow-up of patients. Hence,
Fig. 1 (a) Pre-treament sonogram of greater saphenous vein (GSV); (b) second week follow-up after the EVLA; (c) first month follow-up; (d) third month follow-up;
(e) sixth month follow-up. Total occlusion and gradual decrease in the diameter can be seen
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282 M Köroğlu et al.
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(68 –128 J/cm), and no skin burns, nerve injury or other
major complications related to high energy density were
detected. Due to high occlusion rates and very low compli-
cations in our study we recommend mean energy density of
100 J/cm for a successful EVLA treatment.
US-guided concomitant foam sclerotherapy was used for
the treatment of residual varicosities after endovascular
treatment and perforating veins in our study. Our aim in
this series was to eliminate as much reflux as possible, in
veins of any size in order to achieve maximum long term
patient satisfaction. A high rate of varicose and perforating
vein occlusion was detected in this study. Our data suggest
that EVLA and ultrasound guided concomitant foam scler-
otherapy are the main factors of this high rate of patient sat-
isfaction and good cosmetic results.
The VCSS is recognized as an excellent tool for the evalu-
ation of change in clinical severity of superficial venous
insufficiency and varicose disease (29– 31). We utilized
VCSS to predict and follow-up clinical severity of the
disease, and VAS score to demonstrate patient satisfaction.
Fig. 2 (a) Total Venous Clinical Severity Score (VCSS) value before (blue) and
after (red) the treatment in 60 extremities; (b) Total visual analogue scale (VAS)
scores of the patients before (dark purple) and 6 months after (light purple) the
treatment
the radiologist has an important role in both the diagnosis
and the treatment of this pathologic condition (2, 12).
Surgical treatment of varicose veins is usually performed
under general anesthesia. There is recognized morbidity
associated with surgery, and the recovery to normal activity
usually lasts 2– 3 weeks. Complications of surgical therapy
include neurosensory loss (4 – 25%), wound infection (2 –
15%), hematoma (30%), and deep venous thrombosis
(,2%). Recurrences are as high as 21 – 37% at 5 years post
surgery (3, 16, 17). Less invasive endovascular methods
(radiofrequency ablation [RFA] and EVLA) have been devel-
oped as alternatives to surgery, with the intention of redu-
cing morbidity and recovery time (3, 18– 23). EVLA has
been shown to be at least equivalent to saphenofemoral lig-
ation and stripping with decreased recovery time and peri-
procedural morbidity (2, 21, 24).
In our study 73 EVLA (58 GSV, 15 LSV) and concomitant
US-guided foam sclerotherapy were performed in 60 lower
extremities. At the sixth month follow-up, the total occlu-
sion rate for the saphenous veins was 98.64% (72/73), and
the re-canalization rate was 1.36%, which was in concor-
dance with the literature. No major complications (deep
venous thrombosis, paresthesia, pulmonary emboli) devel-
oped in our study. Energy density (J/cm) is the main deter-
minant of successful saphenous vein occlusion. The ideal
laser energy to achieve permanent vein occlusion without Fig. 3 (a) Mean difference of Visual Analogue Scale scores (VASdifference)
complications is not fully known. Different energy density before the treatment and at the sixth month follow-up was calculated; (b)
values are suggested for EVLA treatment in the literature. Mean difference of Venous Clinical Severity Score values (VCSSdifference)
before the treatment and at the sixth month follow-up was calculated.
Higher doses of laser energy have been shown to be more
Graphics demonstrate minimum, maximum and mean values of these differ-
effective in vessel occlusion and non-re-canalization (3, 22, ences in both Group I (isolated saphenous insufficiency) and Group II (saphe-
25–28). Energy density applied in our study was 100.2 J/cm nous and perforating vein reflux)
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Endovenous laser ablation and foam sclerotherapy for varicose veins 283
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Fig. 4 Pre- and post-treatment photographs of a patient treated with EVLA and concomitant US-guided foam sclerotherapy. Varicose veins and the symptoms of
the patient disappeared totally after the treatment
Mean VCSS value before and 6 months after the treatment both isolated truncal and truncal with perforating vein
was 7.01 + 2.76 and 2.48 + 1.49, respectively. Mean VAS insufficiency groups. However, clinical and patient satisfac-
score in 55 patients, before and 6 months after the treatment tory outcomes were significantly better in cases with iso-
was 7.51 + 1.3 and 2.36 + 1.84, respectively. These lated truncal vein insufficiency than truncal and
decreases in the mean VCSS and VAS scores were statisti- perforating vein insufficiency. Repeated sclerotherapy ses-
cally significant. sions can be needed in patients with perforating vein
This prospective study also compared the results of EVLA insufficiency.
and concomitant foam sclerotherapy in two subgroups (iso-
lated saphenous vein insufficiency vs. perforating vein Conflict of interest: None.
insufficiency along with saphenous insufficiency) of
patients. The difference of VCSS values and VAS scores
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