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Available online at www.sciencedirect.com
www.elsevier.com/locate/semvascsurg
Update of endovenous treatment modalities for
insufficient saphenous veins—A review of literature
Ramon R.J.P. van Eekerena,n, Doeke Boersmab, Jean-Paul P.M. de Vriesb,
Clark J. Zeebregtsc, and Michel M.P.J. Reijnena
a
Department of Surgery, Rijnstate Hospital, P.O. Box 9555, 6800 TA, Arnhem, The Netherlands
Department of Vascular Surgery, St Antonius Hospital, P.O. Box 2500, 3430 EM, Nieuwegein, The Netherlands
c
Department of Surgery, Division of Vascular Surgery, University Medical Center Groningen, University of Groningen,
P.O. Box 30 001, 9700 RB, Groningen, The Netherlands
b
article info
abstract
Lower-limb venous insufficiency resulting from saphenous vein incompetence is a
common disorder, increasing with age. For decades, surgical stripping of the great
saphenous vein has been the gold standard in varicose vein treatment. The desire to
optimize outcomes of treatment and reduce surgical trauma has led to the development of
endovenous techniques. Today, several endovenous techniques are available to ablate the
saphenous vein segments with abnormal vein valve function. In this review, we discuss
the techniques, mechanisms of action, outcomes, and complications of all endovenous
treatment modalities for the treatment of symptomatic lower-limb varicose veins.
& 2015 Elsevier Inc. All rights reserved.
1.
Introduction
Chronic venous insufficiency of the lower extremity is a
common vascular disorder. In a general adult population, only
10% of individuals have no clinical signs of venous disease [1].
Prevalence of superficial vein reflux in the Bonn vein study
was 21% in an adult population, which increased with age in a
linear way [2]. Although all components of the superficial and
deep venous system can be affected, the most predominant
site of reflux in these patients is the great saphenous vein
(GSV). Chronic venous insufficiency has a considerable negative impact on generic and disease-specific quality of life [3],
which is comparable with other chronic disorders [4]. Due to
the high prevalence, treatment of patients with varicose veins
has a substantial financial burden on health care resources.
For many years, the traditional treatment for saphenous
vein insufficiency has been high ligation with or without
n
Corresponding author.
E-mail address: [email protected] (R.R.J.P. van Eekeren).
http://dx.doi.org/10.1053/j.semvascsurg.2015.02.002
0895-7967/$ - see front matter & 2015 Elsevier Inc. All rights reserved.
stripping of the GSV for GSV insufficiency and ligation of the
saphenopopliteal junction in small saphenous vein (SSV)
insufficiency [5]. Long stripping of the GSV was replaced for
a “short strip,” to reduce the risk of saphenous nerve damage
[6]. Surgery is usually performed under general or epidural
anesthesia and is an effective method to eliminate reflux in
the short term. However, recurrent reflux at the groin is a
frequent problem, with an incidence up to 60% after a mean
follow-up of 34 years [7].
Development of minimally invasive procedures was driven
by the aim to reduce surgical trauma and to improve longterm success. Today, endovenous techniques, such as endovenous laser ablation (EVLA), radiofrequency ablation (RFA),
and ultrasound-guided foam sclerotherapy (UGFS) are common procedures in daily practice. Supposed advantages over
traditional surgery include the omission of general and
epidural anesthesia, minimal scars, fewer complications [8],
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less post-procedural pain [9–11], and faster recovery times
[12,13]. Lower recurrence might be the result of decreased
neovascularization in the groin and along the stripped
saphenous vein segment [14]. However, recent metaanalysis report similar long-term results with traditional
surgery and endovenous procedures [15,16].
The revolution of different endovenous therapies makes it
hard for clinicians to recommend an optimal technique for
their patients. This review aims to inform clinicians about
outcomes and complications of all endovenous treatment
modalities for insufficient varicose veins and describe the
various techniques.
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2.
Endovenous laser ablation
saline 0.9% or Ringer’s lactate. The amount of tumescence
anesthesia depends on the length of the vein to be treated.
Tumescence anesthesia provides a cooling area to minimize
thermal injury on the surrounding tissue. In addition, it
induces vasospasm to maximize the effect of heat on the
vascular wall.
The laser fiber is connected to the generator. After activation, the sheath and laser fiber are simultaneously withdrawn
with a speed depending on the power and wavelengths of the
generator. Compression stockings are usually administered
for 1 to 2 weeks after the procedure.
Relative contraindications for EVLA are thrombus in the
target vein, an inability to ambulate, severe arterial disease,
deep vein thrombosis, pregnancy, and patients who are
breastfeeding.
2.1.
Technique
2.2.
EVLA can be performed in an outpatient setting with local
tumescent anesthesia. Oral sedatives, such as diazepam, are
also used occasionally. Patients are placed in an antiTrendelenburg position to enhance venous pressure and to
widen the GSV. The GSV is visualized with duplex ultrasound
and a location for cannulation of the vein is selected. Usually
a diameter of 43 mm makes the vein suitable for venous
access. Normally, the GSV is larger and straighter above than
below the knee, which favors this location for most clinicians.
In addition, the saphenous nerve is more adjacent to the GSV
below the knee, increasing the risk of saphenous nerve
injury.
Venous access is obtained by a micropuncture needle
(16 18Fr) under ultrasound guidance. A guide wire is
advanced through the hollow needle into the GSV and
positioned at the level of the saphenofemoral junction (SFJ).
The standard guide wire is J-tipped and can be advanced
easily. However, severe tortuosity, small diameter of the vein,
thrombotic remnants, or large side branches can harden the
advancement of the guide wire. In this case, caution is
necessary, and proceeding increases the risk of perforation
and embolic complications. The use of different-shaped guide
wires can be helpful in these situations. After the guide wire
has been placed at the level of the SFJ, and a small cutaneous
incision is made, a guiding sheath is advanced over the guide
wire. The guiding sheath is marked every centimeter to
determine the exact length of segment to be treated. Subsequently, the laser fiber can be introduced after removal of
the guide wire. Positioning of the sheath and laser fiber with
duplex ultrasound 15 to 20 mm below the SFJ is the most
essential step of the procedure. Three landmarks for proper
positioning are the superficial epigastric vein, the circumflex
artery between the femoral vein and the GSV, and the valve
at the SFJ.
Tumescence anesthesia is infiltrated along the entire
course of the GSV, starting at the cannulation site. Under
direct ultrasound guidance, tumescence solution should be
injected between the perivenous fascia, so the vein will
collapse through the circumferential surrounding of the
solution. The maximum recommended dose of lidocaine with
epinephrine (1:100,000) is 7 mg/kg, with a maximum amount
of 500 mg. Most tumescence solutions are diluted in 500 mL
Mechanism of action
EVLA uses electromagnetic radiation (light) through a process
of optimal amplification to obliterate the vein [17]. The laser
energy is absorbed by blood in the vein and converted to heat.
As a result, steam bubbles are produced at the tip of the laser
fiber, which distribute along the entire inner vascular wall
and provide homogeneous thermal injury to the endothelium
[18,19]. Steam bubble formation is a local and reversible
process that, after collapse of the bubble, causes no risk of
air embolism to the patient. The volume of the lasergenerated steam bubbles is directly correlated to the amount
of laser energy.
In histologic studies of vein specimens, a completely
damaged intima was found immediately after EVLA [20,21].
Most of the laser-induced injury in the media does not reach
deeper than the inner one-third of the entire vein wall [21].
However, carbonization and perforation are observed, presumably where the tip of the laser has direct contact with the
vein wall. Histologic samples taken from the GSV showed
absence of endothelium, deposits of fibrin in the vascular
lumen, and thrombus organization with evidence of muscle
wall damage, 3 months after EVLA [22].
Lasers with wavelengths from 808 to 1,560 nm have been
used for EVLA. Wavelength is a determinant of laser penetration and absorption by blood. A longer wavelength results
in lower energy absorption and possibly fewer vein perforations. Although several studies analyzed the effect of different wavelengths on the occlusion rate of EVLA, most of the
lasers appeared to have similar results [23,24]. In addition, a
recently developed covered-tip design (jacket-tip, gold-tip,
tulip-tip, ball-tip, radial) employs a cover at the distal tip of
the laser fiber (Fig. 1). This cover prevents the unrevealed bare
tip to have contact with the vein wall, which prevents
perforation and subsequently pain and bruising. Several
studies observed a decrease in postprocedural pain with the
use of covered tips, although a higher failure rate was seen
with covered tips [25,26]. The total amount of energy delivered is expressed as J/cm and reveals the product of power
(W) and the withdrawal velocity of the laser fiber (cm/s). A
range of 60 to 80 J/cm is usually accepted, administered in
either a pulsed or continuous mode. Higher doses of laser
energy have shown to be more effective in venous obliteration, although more side effects can occur [27–29].
120
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Fig. 1 – (A) Laser generator. (B) Magnified view of the distal aspect of the laser fiber (gold tip). Used with permission of
Angiodynamics Inc.
2.3.
Outcome
In 2001, Navarro et al [30] and Min et al [31] were the first to
describe a large series of EVLA [30,31]. Both studies, with 40
and 90 patients, respectively, showed a 100% and 96%
occlusion rate of the treated GSV without significant complications. Several prospective studies have been published
subsequently to determine the outcomes of EVLA in treatment of varicose veins. The reported occlusion rates are listed
in Table 1 and vary between 62% and 100% [9,12,13,23,26,28–
107]. Although occlusion rates 490% are mostly reported in
large series, results seems to decrease with time. A recent
prospective study with 1,020 limbs observed failure rates with
duplex ultrasound of 7.7% at 1 year and 13.1% at 2 and 3 years
[108]. In a randomized controlled trial of EVLA with or without high saphenous ligation, occlusion rates at 5 years followup were 98% and 88% , respectively [86]. The difference
between these groups was not significant. Another large
study including 449 veins reported a 93% occlusion rate after
3 years [32]. A meta-analysis shows that results of EVLA are
significantly more effective than RFA, surgery, and UGFS [16].
2.4.
which occur in almost all patients [109]. High temperatures of
laser energy, which causes small perforations in the vein, are
hypothesized to support this effect. Postprocedural pain
usually revolves within 2 weeks after treatment. The use of
covered-tip lasers or lower laser energy is associated with
reduced postprocedural pain after EVLA [25,26]. Comparative
studies with EVLA and RFA showed significantly less postprocedural pain with the RFA method [106,112]. Also, an
unpleasant burning smell and taste are often mentioned by
patients treated with EVLA [113]. Skin burns have been
reported in the early experiences of EVLA, but might be a
consequence
of
inadequate
tumescence
anesthesia
[26,108,114]. Attention should be paid to situations in which
the insufficient GSV extends into a major side branch outside
the fascia and is situated very superficially. Other seldom
reported complications specific for EVLA are hyperpigmentation, superficial thrombophlebitis, arteriovenous fistula, and
paresthesia [111,115–117]. An exceptional complication is the
remnant of used material in the vasculature [118].
3.
Radiofrequency ablation
3.1.
Technique
Complications
Deep venous thrombosis is considered a major complication
of endothermal treatment, with a reported incidence of 0% to
5.7% [109]. To reduce the risk of thrombosis, proper positioning of the laser tip, with a general distance of 1.5 to 2 cm
below the SFJ, is essential. However, extension of the thrombus of the GSV into the common femoral vein has been
reported [110]. This phenomenon is called endothermal heatinduced thrombosis. Pre-existent thrombophilic disorders and
the use of general anesthesia, which does not allow direct
mobilization after the treatment, are suggested as potential
risk factors for thrombus extension to develop [109]. Some
practitioners recommend routine use of low-molecularweight heparin after EVLA. Pulmonary embolism has only
been described in a few reports, although a direct correlation
with deep venous thrombosis was not observed [111]. The
most common side effects of EVLA are pain and bruising,
RFA can also be performed in an outpatient setting with local
tumescence anesthesia. Preparations and introduction are
similar to EVLA, with the exception that only a short sheath is
used, as the catheter can be advanced without a sheath. The
tip of the RFA catheter is navigated 2 cm below the SFJ under
ultrasound guidance. A guide wire can facilitate advancement if the GSV is too tortuous to pass. Emptying the vein
with a bandage or Trendelenburg positioning can be performed, but is not necessary for the procedure.
The first RFA (VNUSs Medical Technology, San Jose, CA)
catheters relied on a ring of employed electrodes, expandable
to a maximum of 8 to 12 mm in diameter. The employed
electrodes allow direct contact with the vein wall, which is
essential in the RFA procedure. Application of tumescence
anesthesia is similar to EVLA, and optimizes electrode
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27 (2014) 118–136
Table 1 – Published prospective studies of endovenous laser ablation.
Study, first author
Year
Study design
Follow-up (mo)
Sample size (no. of limbs)
Occlusion rate (%)
Navarro [30]
Min [31]
Min [32]
Oh [33]
Proebstle [34]
Goldman [35]
Sadick [36]
Timperman [26]
Disselhoff [37]
De Medeiros [38]
Timperman [28]
Agus [39]
Kabnick [23]
Kavuturu [40]
Kim [41]
Mekako [42]
Myers [43]
Petronelli [44]
Proebstle [29]
Sharif [45]
Yang [46]
Desmyttère [47]
Gibson [48]
Rasmussen [9]
Sadick [49]
Sharif [50]
Theivacumar [51]
Timperman [52]
Yilmaz [53]
Darwood [12]
Disselhoff [54]
Disselhoff [55]
Fernández [56]
Gonzalez-Zeh [57]
Janne d’Othèe [58]
Jung [59]
Knipp [60]
Pannier [61]
Park SJ [62]
Park SW [63]
Theivacumar [64]
Vuylsteke [65]
Huisman [66]
Kontothanassis [67]
Myers [68]
Nwaejike [69]
Nwaejike [70]
Pannier [71]
Theivacumar [72]
Trip-Hoving [73]
Van den Bremer [74]
Zafarghandi [75]
Christenson [76]
Desmyttère [77]
Gale [78]
Goode [106]
Pronk [79]
Rasmussen [80]
Rathod [81]
Satokawa [82]
Schwarz [83]
Vuylsteke [84]
Carradice [85]
Disselhoff [86]
2001
2001
2003
2003
2003
2004
2004
2004
2005
2005
2005
2006
2006
2006
2006
2006
2006
2006
2006
2006
2006
2007
2007
2007
2007
2007
2007
2007
2007
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2008
2009
2009
2009
2009
2009
2009
2009
2009
2009
2009
2010
2010
2010
2010
2010
2010
2010
2010
2010
2010
2011
2011
Prospective
Prospective
Prospective
Prospective
Prospective
Prospective
Prospective
Prospective
Prospective
Prospective
Prospective
Prospective
Prospective
Prospective
Prospective
Prospective
Prospective
Prospective
Prospective
Prospective
Prospective
Prospective
Prospective
RCT
Prospective
Prospective
Prospective
Prospective
Prospective
RCT
RCT
RCT
Prospective
RCT
RCT
Prospective
Prospective
Prospective
Prospective
Prospective
Prospective
Prospective
Prospective
Prospective
Prospective
Prospective
Prospective
Prospective
Prospective
Prospective
Prospective
Prospective
RCT
Prospective
RCT
RCT
RCT
RCT
Prospective
RCT
RCT
Prospective
RCT
RCT
4.2
9
39
3
12
6
24
7
3
2
11
36
12
12
12.2
3
36
12
12
12
13
48
4
6
48
22
6
11
12
3
24
24
30
12
6
3
12
26
12
36
3
6
3
36
48
14
20
12
24
2
2
6
24
36
12
1
12
24
12
21
3
6
12
60
40
90
499
15
109
24
30
111
93
20
100
1076
60
62
34
70
404
52
263
145
71
511
210
69
94
23
68
50
60
71
43
60
1985
45
122
176
460
67
390
96
644
129
169
229
509
66
624
117
69
49
301
77
100
147
72
87
62
69
76
36
312
158
139
43
100
96
93
100
90
100
97
77
84
95
95
97
93
97
100
96
80
93
96
76
94
97.1
96a
94
96
91
100a
100
97
94
88
77
78.3
93
87.6
94.3
95.9
88.1
94.4a
100a
93
90.6
98a
79
76
100a
100
100
92.8
100a
93.7
97
93
100a
97.3
95
91
74
98.6
97
100
93.3
96
79
122
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Table 1 (continued) )
Study, first author
Year
Study design
Follow-up (mo)
Sample size (no. of limbs)
Occlusion rate (%)
Disselhoff [87]
Ergenoglu [88]
Krnic [107]
Nordon [89]
Pannier [90]
Rasmussen [13]
Tesmann [91]
2011
2011
2011
2011
2011
2011
2011
2012
RCT
Prospective
Prospective
RCT
Prospective
RCT
RCT
Prospective
60
12
1
3
6
12
12
12
60
103
53
80
50
144
67
112
62
97.5
98.1
96
100
96
96.9
97
2013
2013
2013
2013
2013
2013
2013
2014
2014
2014
2014
2014
2014
RCT
Prospective
RCT
RCT
RCT
Prospective
Prospective
Prospective
Prospective
Prospective
RCT
Prospective
RCT
12
18
15
60
12
18
12
6
6
32
18
12
12
76
31
44
62
53
50
308
230
45
740
30
355
110
89
94
96
82.1
96.2a
70
99.6
100
100
95
93.6
100
96
Memetoğlu [92]
Biemans [93]
Chen [94]
Lattimer [95]
Rasmussen [96]
Samuel [97]
Scarpelli [98]
Von Hodenberg [99]
Altin [100]
Cavallini [101]
Golbasi [102]
Mozafar [103]
Park [104]
Van den Bos [105]
Abbreviation: RCT, randomized controlled trial.
a
Series of small saphenous veins.
contact with the vein wall by creating vasospasm. It also
provides a protective area for thermal injury. The RFA
catheter is then connected to a radiofrequency generator. A
thermocouple on the catheter monitors the temperature of
the endothelium, and is able to maintain temperature at a
certain level through a feedback system at the generator
[119]. Temperature is normally maintained at 851 to 901C
during withdrawal. The catheter is continuously pulled back
at about 3 cm/min, but can be increased with higher temperature settings [119]. Compression stockings are usually indicated for 1 to 2 weeks after the procedure.
In 2006, the Covidien ClosureFastTM (Covidien, Mansfield,
MA) catheter, formerly known as VNUS ClosureFastTM, was
introduced. This catheter uses segmental ablation in contrast
with a continuous pullback. A heating element at the distal
end of the catheter allows vein segments of 7 cm to be
obliterated in energy cycles of 20 seconds (Fig. 2). The
temperature is maintained at 1201C during an energy cycle.
When the catheter is placed 2 cm below the SFJ, tumescent
anesthesia is applied with a recommended volume of 10 mL/
cm of treated vein. This new technology results in faster
treatment time, and every 20 seconds the catheter is segmentally withdrawn for 7 cm [120]. Notably, the most proximal part of the GSV is treated with two energy cycles.
Radiofrequency-induced thermotherapy (RFITT) (Celon AG,
Medical Instruments, Teltow, Germany) is another technique
using radiofrequency energy. The RFITT catheter has a
rounded tip and contains an acoustic impedance feedback
function, ensuring that the energy output is adapted to the
size of the vein wall. The bipolar catheter tip needs to moved
constantly with a pullback speed of 0.5 to 1 cm per second,
depending on the used power settings of the generator
Fig. 2 – (A) Radiofrequency generator. (B) Magnified view of the ClosureFast catheter. Used with permission of Covidien.
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[91,121]. Administration of 10 to 18 W is recommended for
RFITT [91].
The only contraindication for RFA is pre-existent thrombus
in the treated vein. Also vein diameters of 412 mm can now
be treated with the ClosureFastTM catheter [122].
3.2.
Mechanism of action
RFA involves the delivery of thermal energy from a bipolar
catheter directly to the venous wall. Bipolar electrodes (VNUS
ClosureTM) or bipolar catheters (Covidien ClosureFastTM) are
used to generate temperatures of 801 to 1201C. In contrast to
EVLA, RFA requires direct contact of the endothelium with
the catheter. Therefore, manual compression on the vein
from the outside is recommended by some practitioners to
enhance contact during treatment. Adequate tumescence
anesthesia and emptying of the vein, before treatment, are
also possibilities to increase contact of the catheter with
the vein.
RFITT uses blood and the surrounding vein wall as a
conductor of bipolar energy to generate temperatures up to
601 to 1001C [123]. Therefore, the catheter does not need direct
contact with the vein wall.
Radiofrequency energy causes acute thermal damage to the
endothelium. The heat-related inflammatory response
results in endothelial denudation and swelling of the vein
wall. It also induces restructuring and repair processes with
collagen remodeling and proliferation of fibroblast, leading to
complete occlusion of the vein [124]. In a histologic study
with bovine veins, RFA showed induration and thickening of
the vein wall and contraction of the vein lumen [125]. No
evidence of vein perforation or thermal damage of the
surrounding tissue was observed under macroscopic investigation. However, a complete occlusion was not seen in any
of the treated veins. All veins showed a microscopically
circular disintegration of the intima. Unfortunately, histologic
in vivo studies with RFA are not available to date.
3.3.
Outcome
Several studies have been published on the short- and longterm efficacy of RFA in the treatment of varicose veins. In
2002, Weiss and Weiss reported the first large series in 140
patients with 90% success rate 2 years after treatment [126].
These patients had complete disappearance of the treated
GSV. The largest prospective study, including 1,222 limbs
treated with VNUS ClosureTM, reported vein occlusion rates
after 1 and 5 years of 87.1% and 87.2%, respectively [127].
Clinical improvement was seen in 85% of the limbs with
anatomical success 5 years after RFA. The reported occlusion
rates of prospective series are listed in Table 2 and vary
between 67% and 100% [10,11,13,78,89,91,106,107,120–
122,124,126–160]. First results of radiofrequency segmental
ablation were published by Proebstle et al in 2008 [120].
Occlusion rates were 99.6% obtained from 62 limbs after 6
months. Radiofrequency segmental ablation using the Covidien ClosureFastTM catheter was superior to VNUS ClosureTM,
with occlusion rates of 98% and 88%, respectively, after 1
week [153]. In a randomized controlled study of RFA
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123
comparing ligation of the SFJ and surgical stripping, outcomes after 2 years were identical [151].
3.4.
Complications
In the early series of treatment with RFA, serious side effects,
like paresthesia and skin burns, were reported, but these
incidences decreased after induction of tumescent anesthesia
with RFA [140]. Rates of paresthesia dropped from 14.5% to
9.1% and rates of skin burn decreased from 1.8% to 0.5%. Most
events of paresthesia are transient and resolve spontaneously [127]. Below the knee, the saphenous nerve is located
adjacent to the GSV. Therefore, treatment limited to the
upper limb can significantly reduce paresthesia [131]. Other
possible complications with RFA are comparable to EVLA.
Superficial thrombophlebitis, often described as an erythematous area over the treated vein segment, is inherent to
endovenous procedures, as obliteration of the GSV requires
injury to the vein wall. This self-limiting complication is
reported in approximately 5% [161].
4.
Ultrasound-guided foam sclerotherapy
4.1.
Technique
UGFS is an endovenous sclerosis technique that is performed
in an outpatient setting. Foam is obtained by mixing a
sclerosant with gas. Several methods have been described
to prepare the foam. The most extensively used method is
the Tessari method [162]. Two 5-mL Luerlock syringes are
connected by a three-way stopcock. One syringe contains 1
mL of the sclerosant, the other contains 4 mL room air (ratio
1:4) [163]. This mixture is twisted about 10 to 20 times
between the two syringes and then it becomes foam. Also,
different gases and methods of preparation are described
[164]. The prepared foam is stable for about 2 minutes and
therefore needs quick injection [165,166]. For UGFS of insufficient saphenous veins, two different sclerosants can be used,
including sotradecol (sodium tetradecyl sulphate) 1% and 3%
and polidocanol 1%, 2%, and 3%. The chosen concentration is
related to the diameter of the treated vein segment [167].
Venous access is obtained directly under ultrasound guidance with either a butterfly needle or a microcatheter.
Because most of the foam moves along with the venous flow,
the patient is placed in horizontal or reverse Trendelenburg
position to enhance contact between the vein wall and foam.
For the treatment of GSV insufficiency, the GSV is punctured
around the knee. The foam is injected under continuous
monitoring with ultrasound, and continued until the foam
reaches the SFJ. Some additional injections can be given to
make sure that the insufficient veins and also major tributaries are completely injected with foam. Long catheters are
also used and allow precise deposition of foam throughout
the entire vein [168,169]. In addition, the European Guideline
group advised venous puncture of the proximal thigh to treat
truncal GSVs in 2012 [167]. Some authors advocate manual
compression on the SFJ during UGFS to minimize the flow of
foam into the femoral vein [170]. The use of tumescence
124
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Table 2 – Published prospective studies of radiofrequency ablation.
Study, first author
Year
Study design
Follow-up (mo)
Sample size (no. of limbs)
Occlusion rate (%)
Chandler [128]
Goldman [129]
Manfrini [124]
Goldman [130]
Merchant [161]
Rautio [132]
Sybrandy [133]
Weiss [126]
Fassaidis [134]
Lurie [11]
Hingorani [135]
Pichot [136]
Salles-Cunha [137]
Wagner [138]
Lurie [139]
Merchant [140]
Merchant [127]
Nicolini [141]
Ogawa [142]
Perälä [143]
Hinchliffe [10]
Dunn [144]
Kianifard [145]
Zan [146]
Proebstle [120]
Calcagno [122]
Boon [121]a
Goode [106]a
Creton [147]
Gale [78]
Subramonia [148]
Haqqani [149]
Krnic [107]a
Nordon [89]
Proebstle [150]
Rasmussen [13]
Helmy ElKaffas [151]
Tesmann [91]a
Monahan [152]
Zuniga [153]
García-Madrid [154]
Harlander-Locke [155]
Harlander-Locke [156]
Park [157]
Tolva [158]
Avery [159]
Park [160]
2000
2000
2000
2002
2002
2002
2002
2002
2003
2003
2004
2004
2004
2004
2005
2005
2005
2005
2005
2005
2006
2006
2006
2007
2008
2009
2010
2010
2010
2010
2010
2011
2011
2011
2011
2011
2011
2011
2012
2012
2013
2013
2013
2013
2013
2014
2014
Prospective
Prospective
Prospective
Prospective
Prospective
Prospective
Prospective
Prospective
Prospective
RCT
Prospective
Prospective
Prospective
Prospective
RCT
Prospective
Prospective
Prospective
Prospective
RCT
RCT
Prospective
Prospective
Prospective
Prospective
Prospective
Prospective
RCT
Prospective
RCT
RCT
Prospective
Prospective
RCT
Prospective
RCT
RCT
RCT
Prospective
RCT
Prospective
Prospective
Prospective
Prospective
Prospective
Prospective
Prospective
12
6
6
6
24
10
12
24
12
4
1
25
9
3
24
48
60
36
1
36
1
6
12
24
6
6
10
1
12
12
1
1
1
3
36
12
24
12
3
1
6
6.2
9
21
12
12
24
120
10
151
50
319
33
26
140
59
44
73
63
106
28
44
1,078
1,222
330
25
15
16
85
55
24
252
338
203
87
220
70
47
73
44
79
256
148
90
66
27
355
67
80
1000
60
407
241
46
90
100
93
68
85.2
73.3
88
90
98
95
96
90
82
100
86
88.8
87.2
75
100
66.7
81
90
100
96
99.6
99
89
95
97
84.3
100
100
86.4
97
92
95
94
88.9
100b
98
97
100b
98.6
83.3
98
91
89.1b
Abbreviation: RCT, randomized controlled trial.
a
Radiofrequency-induced thermotherapy.
b
Series of small saphenous veins.
anesthesia to improve results after UGFS shows no beneficial
effect [171].
The amount of foam required for treatment of GSV insufficiency is usually 6 to 8 mL, depending on length and diameter
of the vein [172]. For SSV insufficiency, 4 to 6 mL is sufficient.
The total amount of foam should not exceed 10 mL, as higher
incidence of side effects are reported with higher volumes of
foam [173].
Optionally, the patient stays in horizontal or reverse Trendelenburg position for 5 minutes after injection of foam to
optimize contact between the vein wall and foam. Compression stockings are usually applied for 2 weeks after UGFS
[174]. Absolute contraindications for UGFS are severe allergy
to sclerosants, acute deep vein thrombosis or pulmonary
embolism, local infection in the area of UGFS, and longlasting immobility [167]. In patients with relative contraindications to UGFS (pregnancy, breastfeeding, severe peripheral arterial occlusive disease, high thromboembolic risk,
superficial thrombophlebitis), an individual benefit-to-risk
assessment should be done [167].
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Mechanisms of action
Sclerotherapy is the use of chemical agents to disrupt the
venous wall. Sclerosants act by altering surface tension of
endothelial cells [175]. Endothelial damage occurs directly after
injection resulting in platelet activation and activation of the
coagulation process with thrombus formation [176,177]. The
organization of subendothelial collagen fibers leads to fibrosis
and occlusion of the treated vein. Liquid sclerosants are
diluted by blood, which reduces the delivered concentration
to the vein wall. Foam displaces blood and prolongs direct
contact with the endothelium. Therefore, the efficacy of a
sclerosant can be increased by foam. Foam is composed of
small bubbles of air that are covered with sclerosant. The air
inside the foam allows good visibility under ultrasound guidance. Another advantage of foam over liquid sclerotherapy is
that a given volume of liquid can be used to produce four
times its volume in foam. This allows the use of smaller
amounts of sclerosants to achieve a similar effect.
Sotradecol is a more potent sclerosant than polidocanol.
The mean depth of injury and the percentage of media
damage are significantly higher for sotradecol compared with
polidocanol [165]. Despite the greater stability of polidocanol
over sotradecol, the therapeutic effect of a sclerosant appears
to occur in the first seconds after injection [178]. This
suggests that the active substance of the sclerosant has more
effect than the longevity of contact. Also, higher concentrations of foam sclerosants have greater impact on vein wall
injury [179].
4.3.
Outcome
Foam, in comparison with liquid sclerotherapy of insufficient
saphenous veins, was studied in several randomized trials. A
meta-analysis of these studies shows the superiority of foam
sclerotherapy. Efficacy of foam was 76.8% versus 39.5% with
liquid sclerotherapy [180]. The occlusion rate depends on the
diameter of the vein and concentration of injected foam [181].
A large prospective series of 500 patients shows obliteration of
the GSV in 81% after 3 years [182]. In addition, 14% of patients
required more sessions to obtain these results. The reported
occlusion rates of prospective series are listed in Table 3 and
vary between 36.1% and 97% [13,57,93,95,168,171,174,181–210].
In a randomized controlled trial comparing UGFS versus
surgery in 430 patients with insufficient GSVs, anatomical
success after 2 years was 65% and 79%, respectively [209].
However, clinical outcomes were similar between both groups.
The efficacy of UGFS was inferior to EVLA and RFA in several
randomized studies [13,57].
4.4.
Complications
UGFS appears to be a safe method to obliterate varicose veins.
A large series of 1,025 patients reported side effects in 2.6%
[201]. The incidence of deep venous thrombosis and pulmonary embolism are low. Specific complications for UGFS
include visual disturbances, migraine, and, rarely, transient
ischemic attack, and are caused by migration of foam. Microembolism in the left heart chamber is observed in 33% to 65%
of cases by echocardiography during UGFS [211]. Although
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125
microembolism is detected in the cerebral circulation in 14%
to 42%, severe complications, such as cerebrovascular accidents are seldom reported [212,213]. Some patients may
develop tightness in the chest or coughing, probably an effect
of foam in the lungs [172]. This usually resolves in about 30
minutes. The incidence of hyperpigmentation is up to 33%
[214]. Hyperpigmentation is caused by extravasation of red
blood cells through the damaged vein wall, but disappears in
approximately 70% of patients within 6 months. Compression
therapy results in a significant reduction in hyperpigmentation [215]. Severe allergic reaction to the used sclerosant has
been described, although this condition is very rare [216].
5.
Mechanochemical endovenous ablation
5.1.
Technique
Mechanochemical endovenous ablation (MOCA) is a tumescentless technique that uses the ClariVeins catheter (Vascular Insights LLC, Madison, CT) to obliterate varicose veins. The
ClariVeins system includes a single-use catheter (ClariVeins
infusion catheter) and battery-motorized handle (ClariVeins
handle) that controls wire rotation. A 5-mL syringe is
attached to the handle and delivers the sclerosant. The center
of the catheter is the infusion canal for the liquid sclerosant
and contains a rotating wire. At the end of the wire, a small
ball is attached to the angled tip, which enhances ultrasound
visibility. The wire can be in a sheathed and unsheathed
position, whereby 2 cm of the wire extends distal to the
catheter tip (Fig. 3).
Under ultrasound guidance, the catheter is inserted via a
4Fr or 5Fr microsheath over a guide wire or 18-gauge cannula
and advanced into the GSV. The flexible catheter has a
bended tip in sheathed position, which allows navigation
through moderate tortuous vein segments. Then, the tip of
the wire is placed 0.5 cm below the superior epigastric vein
and the rotating wire is unsheathed by connecting the
catheter to the handle [217]. Proper positioning of the metal
ball below the superior epigastric vein and saphenofemoral
valve is essential, and the wire can snag on either the vein
wall or valve. Before the infusion of the sclerosant wire
rotation is advised for 3 to 10 seconds to create a venospasm
in the proximal GSV, followed by continued rotating and
pullback with infusion of a sclerosant. The pullback speed is 6
to 7 s/cm [218,219]. Compression stockings are usually
administered for 2 weeks after MOCA.
Sotradecol and polidocanol can both be used as liquid
sclerosants. Sclerosant dosage can be obtained from a dosing
chart supplied by the company, and depends on vein treatment length and vein diameter. The maximal sclerosant
volume depends on the patients’ weight when using polidocanol. Instructions for use include treatment with sotradecol
1% for GSV and SSV, and 2% polidocanol for GSV and SSV
[217]. When a tributary branch of the GSV is passed during
MOCA, pullback can be slowed and/or the infusion rate of the
sclerosant can be increased in order to disperse sclerosant
into this branch. The collateral distribution of sclerosant into
tributaries has a beneficial effect and reduces adjunctive
procedures [220].
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Table 3 – Published prospective studies of ultrasound-guided foam sclerotherapy.
Study
Year
Study design
Follow-up (mo)
No. of patients
Occlusion rate (%)
Cabrera [182]
Belcaro [183]
Hamel-Desnos [184]
Barrett [185]
Yamaki [186]
Bountouroglou [187]
Darke [188]
Smith [189]
2000
2003
2003
2004
2004
2006
2006
2006
Prospective
RCT
RCT
Prospective
RCT
RCT
Prospective
Prospective
60
120
1
23
12
3
2
6
500
211
45
100
37
29
220
459
Wright [190]
Brodersen [191]
Ceulen [192]
Hamel-Desnos [193]
Myers [181]
2006
2007
2007
2007
2007
RCT
Prospective
RCT
RCT
Prospective
12
6
12
36
36
437
30
40
148
627
Abela [194]
Gonzalez-Zeh [57]
O’Hare [195]
Ouvry [196]
Rabe [197]
Chapman-Smith [198]
Darvall [199]
Figueiredo [200]
Gillet [201]
Blaise [202]
Bradbury [203]
2008
2008
2008
2008
2008
2009
2009
2009
2009
2010
2010
RCT
RCT
Prospective
RCT
RCT
Prospective
Prospective
RCT
Prospective
RCT
Prospective
1
12
6
24
3
60
12
6
1
36
28
27
53
185
47
54
203
92
27
1,025
143
1,270
Darvall [204]
Nael [205]
Thomasset [174]
Li [206]
Rasmussen [13]
Asciutto [168]
Chen [207]
Shadid [208]
Yamaki [209]
Biemans [93]
Lattimer [95]
Williamsson [169]
Devereux [171]
2010
2010
2010
2011
2011
2012
2012
2012
2012
2013
2013
2013
2014
Prospective
Prospective
Prospective
Prospective
RCT
Prospective
Prospective
RCT
RCT
RCT
RCT
Prospective
RCT
12
6
3
9
12
12
38
24
6
12
15
12
12
333
217
126
59
144
357
288
230
51
77
46
94
25
81
49
84
97
68
79
74
88
82a
78.9
90
80.1
69
53
36a
96
77
74
53
69
35
91a
78
90
79
92
93a
93
64
79
90
84
67
60
65
45
72
67
71
75
Abbreviation: RCT, randomized controlled trial.
Series of small saphenous veins.
a
Contraindications for MOCA are pre-existent thrombus in
the treated vein, use of anticoagulants, and pregnancy. There
is no evidence of treating larger GSV (412 mm) with MOCA.
Manual compression is advised by the company over the
length of the treated vein whenever the vein diameter is 410
mm to enhance mechanical damage to the vein wall.
5.2.
Mechanism of action
MOCA combines mechanical damage to the endothelial layer
using a rotating wire with the infusion of a liquid sclerosant
[221]. The aim of the mechanical damage is to promote
coagulation activation by damaging the endothelium; to
induce vasospasm, reducing the vein diameter; to increase
the action of the sclerosant, and to ensure an even distribution of the sclerosant. The liquid sclerosant then produces
irreversible damage to the cellular membranes of the endothelium, resulting in fibrosis of the vein [176].
A histologic study described a complete disappearance of
the endothelium and fibrosis of the vein, 1 year after MOCA
treatment. Also, considerable damage of the media with
collagen changes was observed [222]. In an ex vivo study,
the mechanical part of the ClariVeins catheter caused subtle
and incomplete destruction of the endothelium without
changes to media or adventitia [223]. The additional effect
of a sclerosant could lead to the preferred complete endothelial disappearance. However, histopathological studies of
MOCA supporting this hypothesis are lacking.
5.3.
Outcome
In 2009, the first clinical study was performed by Elias and
Raines and described 30 limbs treated with sotradecol. Total
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Fig. 3 – (A) The ClariVeins system including ClariVeins handle and ClariVeins catheter. (B) Magnified view of the distal
rotating, angled wire, which extends through the catheter. Used with the permission of Vascular Insights LLC.
occlusion of the treated vein segments was seen in 97% at 6
months and 97% at 2 years follow-up [219,224]. The reported
occlusion rates of prospective series are listed in Table 4 and
vary between 87% and 97% [218–220,224–227]. The largest
series by Bishawi et al reported success in 94% of the 126
patients treated with sotradecol as well as polidocanol [225].
Interestingly, a difference in anatomical success of 87%
versus 97% was observed 6 months after MOCA between
patients treated with polidocanol 1.5% and 2% [226]. In this
observational study, 50 patients with insufficient SSVs were
included. A randomized study comparing MOCA with RFA
reported similar occlusion rates of 92% after 4 weeks [227].
5.4.
6.
Endovenous steam ablation
6.1.
Technique
Endovenous steam ablation (EVSA) is an endovenous technique that uses steam to heat the vein. EVSA can be performed
in an outpatient setting with tumescence anesthesia. Venous
access is obtained by a 16- or 19-gauge cannula or 5Fr
microintroducer set under ultrasound guidance. The steam
ablation catheter is advanced into the GSV and positioned 2
to 3 cm below the SFJ [105,229]. As with other techniques,
proper positioning of the echogenic tip of the catheter is the
most essential step during the treatment. Application of
tumescence anesthesia is similar to EVLA and RFA, and
decreases the venous diameter.
In a special generator, pressurized sterile water is injected
into a microtube that is heated by electrical current. The
heated water is emitted at the tip of a hand piece as pulses of
steam at 1501C. A catheter is connected to the steam-emitting
hand piece and carries the steam into the vein through two
lateral holes near the tip (Fig. 4). At the tip of the catheter, the
temperature decreases to 1201C. After activation, two pulses
of steam are delivered to dispel the condensated water from
the catheter. Then, three pulses are released at the tip of the
Complications
Because no heat is generated with MOCA, heat-related complications, such as skin burn and paresthesia, will not appear.
MOCA is associated with less postprocedural pain compared to
RFA in the first 14 days after treatment, which also results in a
faster recovery [227,228]. Other possible complications are comparable with other endovenous techniques. Deep venous thrombosis and pulmonary embolism have not been described after
MOCA, but are potential complications after all endovenous
procedures. Superficial thrombophlebitis occurs in 12% to 14%,
which is comparable to UGFS [220,226].
Table 4 – Published prospective studies of mechanochemical endovenous ablation.
Study
Year
Study design
Follow-up (mo)
No. of patients
Occlusion rate (%)
Van Eekeren [218]
Elias [219]
Bishawi [225]
Boersma [226]
Elias [224]
Van Eekeren [220]
Bootun [227]
2011
2012
2013
2013
2013
2014
2014
Prospective
Prospective
Prospective
Prospective
Prospective
Prospective
RCT
2
6
6
12
24
12
1
30
30
126
50
29
106
60
87
97
94
94a
97
88
92
Abbreviation: RCT, randomized controlled trial.
Series of small saphenous veins.
a
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Fig. 4 – (A) Steam generator. (B) FlexiVeinTM catheter with two radial opposite holes to emit steam at the distal portion. Used
with permission of CermaVein (Archamps, France).
by fibrotic thrombosis, inflammatory reaction of the media,
and eventually fibrosis of the treated vein [229,231].
catheter to treat the most proximal GSV. The catheter is
pulled down stepwise for segments of 1 cm, applying 2 to 4
pulsed steam puffs/cm. The number of pulses depends on the
vein diameter [105]. The same generator also allows the
ability to obliterate tributaries with a special designed catheter. After the procedure, compression stockings are usually
advised for 1 to 2 weeks.
Relative contraindications for EVSA are comparable to
EVLA and include thrombus in the vein segment to be
treated, immobility, severe arterial disease, deep vein thrombosis, pregnancy, and patients who are breastfeeding.
6.2.
6.3.
Outcome
The first results of EVSA were published by Van den Bos et al
[229] in 2011. Twenty limbs were treated with total occlusion
of 65% at 6 months. The reported recanalization only affected
segments o10 cm of the treated GSV. In a multicenter study
treating 88 veins with GSV insufficiency, success was 96.1%
after 1-year follow-up [232]. The reported occlusion rates in
prospective series are listed in Table 5 and vary between 65%
and 96% [105,229,232,233]. A randomized controlled study
comparing EVSA with RFA showed the inferiority of EVSA,
with success rates of 87% versus 96% after 1 year [105].
However, patients treated with high-dose EVSA reported
similar results compared with EVLA.
Mechanism of action
EVSA utilizes the condensation of steam into water, which
releases lots of energy in a short time and produces a thermal
effect on the vein wall. The steam condensates back to water
and the resulting heat is absorbed by the vein wall. One pulse
has a heating capacity of 60 J. Because the temperature of
steam is delivered in a regulated temperature of 1201C, the
mechanisms of action are very similar to RFA. In vitro
temperature measurements of EVSA showed a longer plateau
phase of heat and lower maximum temperature than EVLA,
which was comparable to RFA [230]. In addition, temperature
significantly rises inside the vein when more pulses of steam
are delivered.
In an animal study, disappearance of the endothelium was
observed immediately after EVSA. This process was followed
6.4.
Complications
Possible complications of EVSA are comparable with those of
EVLA and RFA. Paresthesia is observed in 2% after EVSA [105].
No deep venous thrombosis or pulmonary embolism has
been reported. However, extension of the thrombus for 1
cm in the deep femoral vein was observed, which disappeared after low-molecular-weight heparin treatment [234].
EVSA is associated with significant lower postprocedural pain
than EVLA [105].
Table 5 – Published prospective studies of endovenous steam ablation.
Study
Year
Study design
Follow-up (mo)
No. of patients
Occlusion rate (%)
Van den Bos [229]
Milleret [232]
Mlosek [233]
Van den Bos [105]
2011
2013
2014
2014
Prospective
Prospective
Prospective
RCT
6
12
6
12
20
88
20
117
65
96
95
87
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Discussion
The treatment of varicose veins has changed dramatically
over the past years. Although high saphenous ligation with
surgical stripping has been the gold standard during most of
the 20th century, endovenous techniques have replaced traditional surgery as a result of similar efficacy, faster recovery,
less postprocedural complications, and improved quality of
life [15]. Since the introduction of endovenous techniques,
many prospective series and randomized studies have been
published on the efficacy of treatment. Unfortunately, most
studies are focused on technical feasibility and short-term
outcomes, while evidence of long-term outcomes is thriftily.
Only a few studies have reported occlusion rates more than 5
years after endovenous procedures [86,87,96,127,182,183,198].
Long-term results of randomized controlled studies are
needed to provide an answer on the durability of endovenous
techniques, especially for newer techniques, such as MOCA
and EVSA.
Results of a recent meta-analysis and systematic Cochrane
review suggest that efficacy of EVLA, RFA, and UGFS is
nonsignificantly different compared with surgery [15,235].
However, heterogeneity in the definition of “efficacy” or
“success” is a major problem in comparing results between
techniques. Success and efficacy are often revealed as the
absence of recanalization, which varies from “no evidence of
flow in the treated vein” to “flow in segments less than 15% of
the total treated segment.” Therefore, standardization of
outcome parameters after varicose vein ablation is necessary
to optimize comparison in the future [236].
The most pivotal outcome of varicose vein treatment
should be the clinical outcome that is most important to
patients. Clinical outcomes that are significant for patients
include the relief of symptoms, improvement in quality of
life, prevention of ulceration, and satisfaction with aesthetics.
Deterioration of these patient-specific outcomes is normally
clinical expression of recurrence. However, ultrasoundproven occlusion rates are usually used as substitute for
clinical recurrence, that disregards other causes of recurrence, such as neovascularization, reflux in the GSV below
the knee and tributaries [237].
Several advantages and disadvantages can be summarized
from the current literature. EVLA and RFA report high
occlusion rates, and UGFS often needs multiple treatments
to achieve the same results. Mid-term efficacy of newer
endovenous techniques, like MOCA and EVSA, are not yet
defined. All endovenous techniques are performed in outpatient setting. Major complications are rare and comparable
between procedures [238]. Postprocedural pain is related to
the amount of heat that is released during treatment. RFA,
UGFS, and EVSA have reported less postprocedural pain
compared to EVLA [13,105,112]. MOCA is associated with
significantly less postprocedural pain than RFA [228]. An
advantage of UGFS and MOCA over endothermal techniques
is the omission of tumescence anesthesia, which is time
consuming and needs multiple injections.
Some considerations should be given to the costeffectiveness of endovenous procedures, while reimbursement for the treatment of varicose veins is not guaranteed in
R G E R Y
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129
several countries. Procedural costs of UGFS are lower than
with EVLA and RFA, due to the use of disposable catheters
and a generator [13]. However, costs of treatment failures,
adjunctive procedures of tributaries, and speed of recovery
are also important parameters influencing cost-effectiveness.
In a systematic review, differences between these parameters
were negligible and cost-effectiveness is therefore associated
with long-term clinical success of the treatment [239].
This literature review aimed to describe the current performance of endovenous techniques in the treatment of
varicose veins. As a consequence of their potential advantages in patient’s comfort and low incidence of complications, several evolutions are made in nonthermal ablation.
New techniques as endovenous cyanoacrylate glue (VenasealTM Sapheon Closure System), ready-made low nitrogen
foam (Varithenas), and installation of an occlusion device in
combination with liquid sclerotherapy (V-Blocks) have been
developed recently. These promising technologies were not
included in this review because the level of clinical evidence
is low at this moment.
In conclusion, all endovenous procedures for the treatment
of varicose veins are effective in abolishing reflux. More longterm results of clinical outcome parameters and costs are
needed to recommend a specific technique as the gold
standard in endovenous varicose vein treatment. Strategies
to obtain long-term clinical outcomes and patient satisfaction
should contain multimodal approaches, in which several
advantages of techniques can be exploited.
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