update of endovenous treatment modalities for insufficient ...€¦ · modalities for insufﬁcient...

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Update of endovenous treatment modalities forinsufficient 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

aDepartment of Surgery, Rijnstate Hospital, P.O. Box 9555, 6800 TA, Arnhem, The NetherlandsbDepartment of Vascular Surgery, St Antonius Hospital, P.O. Box 2500, 3430 EM, Nieuwegein, The NetherlandscDepartment of Surgery, Division of Vascular Surgery, University Medical Center Groningen, University of Groningen,P.O. Box 30 001, 9700 RB, Groningen, The Netherlands

a r t i c l e i n f o

dx.doi.org/10.1053/j.semvascsurg.2015967/$ - see front matter & 2015 Elsevie

responding author.ail address: [email protected]

a b s t r a c t

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 acommon vascular disorder. In a general adult population, only10% of individuals have no clinical signs of venous disease [1].Prevalence of superficial vein reflux in the Bonn vein studywas 21% in an adult population, which increased with age in alinear way [2]. Although all components of the superficial anddeep venous system can be affected, the most predominantsite of reflux in these patients is the great saphenous vein(GSV). Chronic venous insufficiency has a considerable neg-ative impact on generic and disease-specific quality of life [3],which is comparable with other chronic disorders [4]. Due tothe high prevalence, treatment of patients with varicose veinshas 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

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l (R.R.J.P. van Eekeren).

stripping of the GSV for GSV insufficiency and ligation of thesaphenopopliteal junction in small saphenous vein (SSV)insufficiency [5]. Long stripping of the GSV was replaced fora “short strip,” to reduce the risk of saphenous nerve damage[6]. Surgery is usually performed under general or epiduralanesthesia and is an effective method to eliminate reflux inthe short term. However, recurrent reflux at the groin is afrequent problem, with an incidence up to 60% after a meanfollow-up of 34 years [7].Development of minimally invasive procedures was driven

by the aim to reduce surgical trauma and to improve long-term success. Today, endovenous techniques, such as endo-venous laser ablation (EVLA), radiofrequency ablation (RFA),and ultrasound-guided foam sclerotherapy (UGFS) are com-mon procedures in daily practice. Supposed advantages overtraditional surgery include the omission of general andepidural 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 decreasedneovascularization in the groin and along the strippedsaphenous vein segment [14]. However, recent meta-analysis report similar long-term results with traditionalsurgery and endovenous procedures [15,16].The revolution of different endovenous therapies makes it

hard for clinicians to recommend an optimal technique fortheir patients. This review aims to inform clinicians aboutoutcomes and complications of all endovenous treatmentmodalities for insufficient varicose veins and describe thevarious techniques.

2. Endovenous laser ablation

2.1. Technique

EVLA can be performed in an outpatient setting with localtumescent anesthesia. Oral sedatives, such as diazepam, arealso used occasionally. Patients are placed in an anti-Trendelenburg position to enhance venous pressure and towiden the GSV. The GSV is visualized with duplex ultrasoundand a location for cannulation of the vein is selected. Usuallya diameter of 43 mm makes the vein suitable for venousaccess. Normally, the GSV is larger and straighter above thanbelow the knee, which favors this location for most clinicians.In addition, the saphenous nerve is more adjacent to the GSVbelow the knee, increasing the risk of saphenous nerveinjury.Venous access is obtained by a micropuncture needle

(16�18Fr) under ultrasound guidance. A guide wire isadvanced through the hollow needle into the GSV andpositioned at the level of the saphenofemoral junction (SFJ).The standard guide wire is J-tipped and can be advancedeasily. However, severe tortuosity, small diameter of the vein,thrombotic remnants, or large side branches can harden theadvancement of the guide wire. In this case, caution isnecessary, and proceeding increases the risk of perforationand embolic complications. The use of different-shaped guidewires can be helpful in these situations. After the guide wirehas been placed at the level of the SFJ, and a small cutaneousincision is made, a guiding sheath is advanced over the guidewire. The guiding sheath is marked every centimeter todetermine the exact length of segment to be treated. Sub-sequently, the laser fiber can be introduced after removal ofthe guide wire. Positioning of the sheath and laser fiber withduplex ultrasound 15 to 20 mm below the SFJ is the mostessential step of the procedure. Three landmarks for properpositioning are the superficial epigastric vein, the circumflexartery between the femoral vein and the GSV, and the valveat the SFJ.Tumescence anesthesia is infiltrated along the entire

course of the GSV, starting at the cannulation site. Underdirect ultrasound guidance, tumescence solution should beinjected between the perivenous fascia, so the vein willcollapse through the circumferential surrounding of thesolution. The maximum recommended dose of lidocaine withepinephrine (1:100,000) is 7 mg/kg, with a maximum amountof 500 mg. Most tumescence solutions are diluted in 500 mL

saline 0.9% or Ringer’s lactate. The amount of tumescenceanesthesia depends on the length of the vein to be treated.Tumescence anesthesia provides a cooling area to minimizethermal injury on the surrounding tissue. In addition, itinduces vasospasm to maximize the effect of heat on thevascular wall.The laser fiber is connected to the generator. After activa-

tion, the sheath and laser fiber are simultaneously withdrawnwith a speed depending on the power and wavelengths of thegenerator. Compression stockings are usually administeredfor 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 arebreastfeeding.

2.2. Mechanism of action

EVLA uses electromagnetic radiation (light) through a processof optimal amplification to obliterate the vein [17]. The laserenergy is absorbed by blood in the vein and converted to heat.As a result, steam bubbles are produced at the tip of the laserfiber, which distribute along the entire inner vascular walland provide homogeneous thermal injury to the endothelium[18,19]. Steam bubble formation is a local and reversibleprocess that, after collapse of the bubble, causes no risk ofair embolism to the patient. The volume of the laser-generated steam bubbles is directly correlated to the amountof 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 reachdeeper than the inner one-third of the entire vein wall [21].However, carbonization and perforation are observed, pre-sumably where the tip of the laser has direct contact with thevein wall. Histologic samples taken from the GSV showedabsence of endothelium, deposits of fibrin in the vascularlumen, and thrombus organization with evidence of musclewall 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 pene-tration and absorption by blood. A longer wavelength resultsin lower energy absorption and possibly fewer vein perfora-tions. Although several studies analyzed the effect of differ-ent wavelengths on the occlusion rate of EVLA, most of thelasers appeared to have similar results [23,24]. In addition, arecently developed covered-tip design (jacket-tip, gold-tip,tulip-tip, ball-tip, radial) employs a cover at the distal tip ofthe laser fiber (Fig. 1). This cover prevents the unrevealed baretip to have contact with the vein wall, which preventsperforation and subsequently pain and bruising. Severalstudies observed a decrease in postprocedural pain with theuse of covered tips, although a higher failure rate was seenwith covered tips [25,26]. The total amount of energy deliv-ered is expressed as J/cm and reveals the product of power(W) and the withdrawal velocity of the laser fiber (cm/s). Arange of 60 to 80 J/cm is usually accepted, administered ineither a pulsed or continuous mode. Higher doses of laserenergy have shown to be more effective in venous obliter-ation, although more side effects can occur [27–29].

Fig. 1 – (A) Laser generator. (B) Magnified view of the distal aspect of the laser fiber (gold tip). Used with permission ofAngiodynamics Inc.


2.3. Outcome

In 2001, Navarro et al [30] and Min et al [31] were the first todescribe a large series of EVLA [30,31]. Both studies, with 40and 90 patients, respectively, showed a 100% and 96%occlusion rate of the treated GSV without significant compli-cations. Several prospective studies have been publishedsubsequently to determine the outcomes of EVLA in treat-ment of varicose veins. The reported occlusion rates are listedin Table 1 and vary between 62% and 100% [9,12,13,23,26,28–107]. Although occlusion rates 490% are mostly reported inlarge series, results seems to decrease with time. A recentprospective study with 1,020 limbs observed failure rates withduplex 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 with-out high saphenous ligation, occlusion rates at 5 years follow-up were 98% and 88% , respectively [86]. The differencebetween these groups was not significant. Another largestudy including 449 veins reported a 93% occlusion rate after3 years [32]. A meta-analysis shows that results of EVLA aresignificantly more effective than RFA, surgery, and UGFS [16].

2.4. Complications

Deep venous thrombosis is considered a major complicationof endothermal treatment, with a reported incidence of 0% to5.7% [109]. To reduce the risk of thrombosis, proper position-ing of the laser tip, with a general distance of 1.5 to 2 cmbelow the SFJ, is essential. However, extension of the throm-bus of the GSV into the common femoral vein has beenreported [110]. This phenomenon is called endothermal heat-induced thrombosis. Pre-existent thrombophilic disorders andthe use of general anesthesia, which does not allow directmobilization after the treatment, are suggested as potentialrisk factors for thrombus extension to develop [109]. Somepractitioners recommend routine use of low-molecular-weight heparin after EVLA. Pulmonary embolism has onlybeen described in a few reports, although a direct correlationwith deep venous thrombosis was not observed [111]. Themost common side effects of EVLA are pain and bruising,

which occur in almost all patients [109]. High temperatures oflaser energy, which causes small perforations in the vein, arehypothesized to support this effect. Postprocedural painusually revolves within 2 weeks after treatment. The use ofcovered-tip lasers or lower laser energy is associated withreduced postprocedural pain after EVLA [25,26]. Comparativestudies with EVLA and RFA showed significantly less post-procedural pain with the RFA method [106,112]. Also, anunpleasant burning smell and taste are often mentioned bypatients treated with EVLA [113]. Skin burns have beenreported in the early experiences of EVLA, but might be aconsequence of inadequate tumescence anesthesia[26,108,114]. Attention should be paid to situations in whichthe insufficient GSV extends into a major side branch outsidethe fascia and is situated very superficially. Other seldomreported complications specific for EVLA are hyperpigmenta-tion, superficial thrombophlebitis, arteriovenous fistula, andparesthesia [111,115–117]. An exceptional complication is theremnant of used material in the vasculature [118].

3. Radiofrequency ablation

3.1. Technique

RFA can also be performed in an outpatient setting with localtumescence anesthesia. Preparations and introduction aresimilar to EVLA, with the exception that only a short sheath isused, as the catheter can be advanced without a sheath. Thetip of the RFA catheter is navigated 2 cm below the SFJ underultrasound guidance. A guide wire can facilitate advance-ment if the GSV is too tortuous to pass. Emptying the veinwith a bandage or Trendelenburg positioning can be per-formed, but is not necessary for the procedure.The first RFA (VNUSs Medical Technology, San Jose, CA)

catheters relied on a ring of employed electrodes, expandableto a maximum of 8 to 12 mm in diameter. The employedelectrodes allow direct contact with the vein wall, which isessential in the RFA procedure. Application of tumescenceanesthesia is similar to EVLA, and optimizes electrode

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] 2001 Prospective 4.2 40 100Min [31] 2001 Prospective 9 90 96Min [32] 2003 Prospective 39 499 93Oh [33] 2003 Prospective 3 15 100Proebstle [34] 2003 Prospective 12 109 90Goldman [35] 2004 Prospective 6 24 100Sadick [36] 2004 Prospective 24 30 97Timperman [26] 2004 Prospective 7 111 77Disselhoff [37] 2005 Prospective 3 93 84De Medeiros [38] 2005 Prospective 2 20 95Timperman [28] 2005 Prospective 11 100 95Agus [39] 2006 Prospective 36 1076 97Kabnick [23] 2006 Prospective 12 60 93Kavuturu [40] 2006 Prospective 12 62 97Kim [41] 2006 Prospective 12.2 34 100Mekako [42] 2006 Prospective 3 70 96Myers [43] 2006 Prospective 36 404 80Petronelli [44] 2006 Prospective 12 52 93Proebstle [29] 2006 Prospective 12 263 96Sharif [45] 2006 Prospective 12 145 76Yang [46] 2006 Prospective 13 71 94Desmyttère [47] 2007 Prospective 48 511 97.1Gibson [48] 2007 Prospective 4 210 96a

Rasmussen [9] 2007 RCT 6 69 94Sadick [49] 2007 Prospective 48 94 96Sharif [50] 2007 Prospective 22 23 91Theivacumar [51] 2007 Prospective 6 68 100a

Timperman [52] 2007 Prospective 11 50 100Yilmaz [53] 2007 Prospective 12 60 97Darwood [12] 2008 RCT 3 71 94Disselhoff [54] 2008 RCT 24 43 88Disselhoff [55] 2008 RCT 24 60 77Fernández [56] 2008 Prospective 30 1985 78.3Gonzalez-Zeh [57] 2008 RCT 12 45 93Janne d’Othèe [58] 2008 RCT 6 122 87.6Jung [59] 2008 Prospective 3 176 94.3Knipp [60] 2008 Prospective 12 460 95.9Pannier [61] 2008 Prospective 26 67 88.1Park SJ [62] 2008 Prospective 12 390 94.4a

Park SW [63] 2008 Prospective 36 96 100a

Theivacumar [64] 2008 Prospective 3 644 93Vuylsteke [65] 2008 Prospective 6 129 90.6Huisman [66] 2009 Prospective 3 169 98a

Kontothanassis [67] 2009 Prospective 36 229 79Myers [68] 2009 Prospective 48 509 76Nwaejike [69] 2009 Prospective 14 66 100a

Nwaejike [70] 2009 Prospective 20 624 100Pannier [71] 2009 Prospective 12 117 100Theivacumar [72] 2009 Prospective 24 69 92.8Trip-Hoving [73] 2009 Prospective 2 49 100a

Van den Bremer [74] 2009 Prospective 2 301 93.7Zafarghandi [75] 2009 Prospective 6 77 97Christenson [76] 2010 RCT 24 100 93Desmyttère [77] 2010 Prospective 36 147 100a

Gale [78] 2010 RCT 12 72 97.3Goode [106] 2010 RCT 1 87 95Pronk [79] 2010 RCT 12 62 91Rasmussen [80] 2010 RCT 24 69 74Rathod [81] 2010 Prospective 12 76 98.6Satokawa [82] 2010 RCT 21 36 97Schwarz [83] 2010 RCT 3 312 100Vuylsteke [84] 2010 Prospective 6 158 93.3Carradice [85] 2011 RCT 12 139 96Disselhoff [86] 2011 RCT 60 43 79


Table 1 (continued) )


Disselhoff [87] 2011 RCT 60 60 62Ergenoglu [88] 2011 Prospective 12 103 97.5Krnic [107] 2011 Prospective 1 53 98.1Nordon [89] 2011 RCT 3 80 96Pannier [90] 2011 Prospective 6 50 100Rasmussen [13] 2011 RCT 12 144 96Tesmann [91] 2011 RCT 12 67 96.9

Memetoğlu [92] 2012 Prospective 12 112 97

Biemans [93] 2013 RCT 12 76 89Chen [94] 2013 Prospective 18 31 94Lattimer [95] 2013 RCT 15 44 96Rasmussen [96] 2013 RCT 60 62 82.1Samuel [97] 2013 RCT 12 53 96.2a

Scarpelli [98] 2013 Prospective 18 50 70Von Hodenberg [99] 2013 Prospective 12 308 99.6Altin [100] 2014 Prospective 6 230 100Cavallini [101] 2014 Prospective 6 45 100Golbasi [102] 2014 Prospective 32 740 95Mozafar [103] 2014 RCT 18 30 93.6Park [104] 2014 Prospective 12 355 100Van den Bos [105] 2014 RCT 12 110 96

Abbreviation: RCT, randomized controlled trial.a Series of small saphenous veins.


contact with the vein wall by creating vasospasm. It alsoprovides a protective area for thermal injury. The RFAcatheter is then connected to a radiofrequency generator. Athermocouple on the catheter monitors the temperature ofthe endothelium, and is able to maintain temperature at acertain level through a feedback system at the generator[119]. Temperature is normally maintained at 851 to 901Cduring withdrawal. The catheter is continuously pulled backat about 3 cm/min, but can be increased with higher temper-ature settings [119]. Compression stockings are usually indi-cated for 1 to 2 weeks after the procedure.In 2006, the Covidien ClosureFastTM (Covidien, Mansfield,

MA) catheter, formerly known as VNUS ClosureFastTM, wasintroduced. This catheter uses segmental ablation in contrastwith a continuous pullback. A heating element at the distalend of the catheter allows vein segments of 7 cm to be

Fig. 2 – (A) Radiofrequency generator. (B) Magnified view of th

obliterated in energy cycles of 20 seconds (Fig. 2). Thetemperature is maintained at 1201C during an energy cycle.When the catheter is placed 2 cm below the SFJ, tumescentanesthesia is applied with a recommended volume of 10 mL/cm of treated vein. This new technology results in fastertreatment time, and every 20 seconds the catheter is seg-mentally withdrawn for 7 cm [120]. Notably, the most prox-imal part of the GSV is treated with two energy cycles.Radiofrequency-induced thermotherapy (RFITT) (Celon AG,

Medical Instruments, Teltow, Germany) is another techniqueusing radiofrequency energy. The RFITT catheter has arounded tip and contains an acoustic impedance feedbackfunction, ensuring that the energy output is adapted to thesize of the vein wall. The bipolar catheter tip needs to movedconstantly with a pullback speed of 0.5 to 1 cm per second,depending on the used power settings of the generator

e ClosureFast catheter. Used with permission of Covidien.


[91,121]. Administration of 10 to 18 W is recommended forRFITT [91].The only contraindication for RFA is pre-existent thrombus

in the treated vein. Also vein diameters of 412 mm can nowbe treated with the ClosureFastTM catheter [122].


RFA involves the delivery of thermal energy from a bipolarcatheter directly to the venous wall. Bipolar electrodes (VNUSClosureTM) or bipolar catheters (Covidien ClosureFastTM) areused to generate temperatures of 801 to 1201C. In contrast toEVLA, RFA requires direct contact of the endothelium withthe catheter. Therefore, manual compression on the veinfrom the outside is recommended by some practitioners toenhance contact during treatment. Adequate tumescenceanesthesia and emptying of the vein, before treatment, arealso possibilities to increase contact of the catheter withthe vein.RFITT uses blood and the surrounding vein wall as a

conductor of bipolar energy to generate temperatures up to601 to 1001C [123]. Therefore, the catheter does not need directcontact with the vein wall.Radiofrequency energy causes acute thermal damage to the

endothelium. The heat-related inflammatory responseresults in endothelial denudation and swelling of the veinwall. It also induces restructuring and repair processes withcollagen remodeling and proliferation of fibroblast, leading tocomplete occlusion of the vein [124]. In a histologic studywith bovine veins, RFA showed induration and thickening ofthe vein wall and contraction of the vein lumen [125]. Noevidence of vein perforation or thermal damage of thesurrounding tissue was observed under macroscopic inves-tigation. However, a complete occlusion was not seen in anyof the treated veins. All veins showed a microscopicallycircular disintegration of the intima. Unfortunately, histologicin vivo studies with RFA are not available to date.

3.3. Outcome

Several studies have been published on the short- and long-term efficacy of RFA in the treatment of varicose veins. In2002, Weiss and Weiss reported the first large series in 140patients with 90% success rate 2 years after treatment [126].These patients had complete disappearance of the treatedGSV. The largest prospective study, including 1,222 limbstreated with VNUS ClosureTM, reported vein occlusion ratesafter 1 and 5 years of 87.1% and 87.2%, respectively [127].Clinical improvement was seen in 85% of the limbs withanatomical success 5 years after RFA. The reported occlusionrates of prospective series are listed in Table 2 and varybetween 67% and 100% [10,11,13,78,89,91,106,107,120–122,124,126–160]. First results of radiofrequency segmentalablation were published by Proebstle et al in 2008 [120].Occlusion rates were 99.6% obtained from 62 limbs after 6months. Radiofrequency segmental ablation using the Covi-dien ClosureFastTM catheter was superior to VNUS ClosureTM,with occlusion rates of 98% and 88%, respectively, after 1week [153]. In a randomized controlled study of RFA

comparing ligation of the SFJ and surgical stripping, out-comes 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 theseincidences decreased after induction of tumescent anesthesiawith RFA [140]. Rates of paresthesia dropped from 14.5% to9.1% and rates of skin burn decreased from 1.8% to 0.5%. Mostevents of paresthesia are transient and resolve spontane-ously [127]. Below the knee, the saphenous nerve is locatedadjacent to the GSV. Therefore, treatment limited to theupper limb can significantly reduce paresthesia [131]. Otherpossible complications with RFA are comparable to EVLA.Superficial thrombophlebitis, often described as an erythem-atous area over the treated vein segment, is inherent toendovenous procedures, as obliteration of the GSV requiresinjury to the vein wall. This self-limiting complication isreported in approximately 5% [161].

4. Ultrasound-guided foam sclerotherapy

4.1. Technique

UGFS is an endovenous sclerosis technique that is performedin an outpatient setting. Foam is obtained by mixing asclerosant with gas. Several methods have been describedto prepare the foam. The most extensively used method isthe Tessari method [162]. Two 5-mL Luerlock syringes areconnected by a three-way stopcock. One syringe contains 1mL of the sclerosant, the other contains 4 mL room air (ratio1:4) [163]. This mixture is twisted about 10 to 20 timesbetween 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 andtherefore needs quick injection [165,166]. For UGFS of insuffi-cient 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 isrelated to the diameter of the treated vein segment [167].Venous access is obtained directly under ultrasound guid-

ance 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 Trendelenburgposition to enhance contact between the vein wall and foam.For the treatment of GSV insufficiency, the GSV is puncturedaround the knee. The foam is injected under continuousmonitoring with ultrasound, and continued until the foamreaches the SFJ. Some additional injections can be given tomake sure that the insufficient veins and also major tribu-taries are completely injected with foam. Long catheters arealso used and allow precise deposition of foam throughoutthe entire vein [168,169]. In addition, the European Guidelinegroup advised venous puncture of the proximal thigh to treattruncal GSVs in 2012 [167]. Some authors advocate manualcompression on the SFJ during UGFS to minimize the flow offoam into the femoral vein [170]. The use of tumescence

Table 2 – Published prospective studies of radiofrequency ablation.


Chandler [128] 2000 Prospective 12 120 90Goldman [129] 2000 Prospective 6 10 100Manfrini [124] 2000 Prospective 6 151 93Goldman [130] 2002 Prospective 6 50 68Merchant [161] 2002 Prospective 24 319 85.2Rautio [132] 2002 Prospective 10 33 73.3Sybrandy [133] 2002 Prospective 12 26 88Weiss [126] 2002 Prospective 24 140 90Fassaidis [134] 2003 Prospective 12 59 98Lurie [11] 2003 RCT 4 44 95Hingorani [135] 2004 Prospective 1 73 96Pichot [136] 2004 Prospective 25 63 90Salles-Cunha [137] 2004 Prospective 9 106 82Wagner [138] 2004 Prospective 3 28 100Lurie [139] 2005 RCT 24 44 86Merchant [140] 2005 Prospective 48 1,078 88.8Merchant [127] 2005 Prospective 60 1,222 87.2Nicolini [141] 2005 Prospective 36 330 75Ogawa [142] 2005 Prospective 1 25 100Perälä [143] 2005 RCT 36 15 66.7Hinchliffe [10] 2006 RCT 1 16 81Dunn [144] 2006 Prospective 6 85 90Kianifard [145] 2006 Prospective 12 55 100Zan [146] 2007 Prospective 24 24 96Proebstle [120] 2008 Prospective 6 252 99.6Calcagno [122] 2009 Prospective 6 338 99Boon [121]a 2010 Prospective 10 203 89Goode [106]a 2010 RCT 1 87 95Creton [147] 2010 Prospective 12 220 97Gale [78] 2010 RCT 12 70 84.3Subramonia [148] 2010 RCT 1 47 100Haqqani [149] 2011 Prospective 1 73 100Krnic [107]a 2011 Prospective 1 44 86.4Nordon [89] 2011 RCT 3 79 97Proebstle [150] 2011 Prospective 36 256 92Rasmussen [13] 2011 RCT 12 148 95Helmy ElKaffas [151] 2011 RCT 24 90 94Tesmann [91]a 2011 RCT 12 66 88.9Monahan [152] 2012 Prospective 3 27 100b

Zuniga [153] 2012 RCT 1 355 98García-Madrid [154] 2013 Prospective 6 67 97Harlander-Locke [155] 2013 Prospective 6.2 80 100b

Harlander-Locke [156] 2013 Prospective 9 1000 98.6Park [157] 2013 Prospective 21 60 83.3Tolva [158] 2013 Prospective 12 407 98Avery [159] 2014 Prospective 12 241 91Park [160] 2014 Prospective 24 46 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 beneficialeffect [171].The amount of foam required for treatment of GSV insuffi-

ciency is usually 6 to 8 mL, depending on length and diameterof the vein [172]. For SSV insufficiency, 4 to 6 mL is sufficient.The total amount of foam should not exceed 10 mL, as higherincidence of side effects are reported with higher volumes offoam [173].Optionally, the patient stays in horizontal or reverse Tren-

delenburg position for 5 minutes after injection of foam to

optimize contact between the vein wall and foam. Compres-sion stockings are usually applied for 2 weeks after UGFS[174]. Absolute contraindications for UGFS are severe allergyto sclerosants, acute deep vein thrombosis or pulmonaryembolism, local infection in the area of UGFS, and long-lasting immobility [167]. In patients with relative contra-indications to UGFS (pregnancy, breastfeeding, severe periph-eral arterial occlusive disease, high thromboembolic risk,superficial thrombophlebitis), an individual benefit-to-riskassessment should be done [167].


4.2. Mechanisms of action

Sclerotherapy is the use of chemical agents to disrupt thevenous wall. Sclerosants act by altering surface tension ofendothelial cells [175]. Endothelial damage occurs directly afterinjection resulting in platelet activation and activation of thecoagulation process with thrombus formation [176,177]. Theorganization of subendothelial collagen fibers leads to fibrosisand occlusion of the treated vein. Liquid sclerosants arediluted by blood, which reduces the delivered concentrationto the vein wall. Foam displaces blood and prolongs directcontact with the endothelium. Therefore, the efficacy of asclerosant can be increased by foam. Foam is composed ofsmall bubbles of air that are covered with sclerosant. The airinside the foam allows good visibility under ultrasound guid-ance. Another advantage of foam over liquid sclerotherapy isthat a given volume of liquid can be used to produce fourtimes its volume in foam. This allows the use of smalleramounts of sclerosants to achieve a similar effect.Sotradecol is a more potent sclerosant than polidocanol.

The mean depth of injury and the percentage of mediadamage are significantly higher for sotradecol compared withpolidocanol [165]. Despite the greater stability of polidocanolover sotradecol, the therapeutic effect of a sclerosant appearsto occur in the first seconds after injection [178]. Thissuggests that the active substance of the sclerosant has moreeffect than the longevity of contact. Also, higher concentra-tions of foam sclerosants have greater impact on vein wallinjury [179].

4.3. Outcome

Foam, in comparison with liquid sclerotherapy of insufficientsaphenous veins, was studied in several randomized trials. Ameta-analysis of these studies shows the superiority of foamsclerotherapy. Efficacy of foam was 76.8% versus 39.5% withliquid sclerotherapy [180]. The occlusion rate depends on thediameter of the vein and concentration of injected foam [181].A large prospective series of 500 patients shows obliteration ofthe GSV in 81% after 3 years [182]. In addition, 14% of patientsrequired more sessions to obtain these results. The reportedocclusion rates of prospective series are listed in Table 3 andvary between 36.1% and 97% [13,57,93,95,168,171,174,181–210].In a randomized controlled trial comparing UGFS versussurgery in 430 patients with insufficient GSVs, anatomicalsuccess 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 severalrandomized 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 pulmo-nary embolism are low. Specific complications for UGFSinclude visual disturbances, migraine, and, rarely, transientischemic attack, and are caused by migration of foam. Micro-embolism in the left heart chamber is observed in 33% to 65%of cases by echocardiography during UGFS [211]. Although

microembolism is detected in the cerebral circulation in 14%to 42%, severe complications, such as cerebrovascular acci-dents are seldom reported [212,213]. Some patients maydevelop tightness in the chest or coughing, probably an effectof foam in the lungs [172]. This usually resolves in about 30minutes. The incidence of hyperpigmentation is up to 33%[214]. Hyperpigmentation is caused by extravasation of redblood cells through the damaged vein wall, but disappears inapproximately 70% of patients within 6 months. Compressiontherapy results in a significant reduction in hyperpigmenta-tion [215]. Severe allergic reaction to the used sclerosant hasbeen described, although this condition is very rare [216].

5. Mechanochemical endovenous ablation

5.1. Technique

Mechanochemical endovenous ablation (MOCA) is a tumes-centless technique that uses the ClariVeins catheter (Vascu-lar Insights LLC, Madison, CT) to obliterate varicose veins. TheClariVeins system includes a single-use catheter (ClariVeins

infusion catheter) and battery-motorized handle (ClariVeins

handle) that controls wire rotation. A 5-mL syringe isattached to the handle and delivers the sclerosant. The centerof the catheter is the infusion canal for the liquid sclerosantand contains a rotating wire. At the end of the wire, a smallball is attached to the angled tip, which enhances ultrasoundvisibility. The wire can be in a sheathed and unsheathedposition, whereby 2 cm of the wire extends distal to thecatheter tip (Fig. 3).Under ultrasound guidance, the catheter is inserted via a

4Fr or 5Fr microsheath over a guide wire or 18-gauge cannulaand advanced into the GSV. The flexible catheter has abended tip in sheathed position, which allows navigationthrough moderate tortuous vein segments. Then, the tip ofthe wire is placed 0.5 cm below the superior epigastric veinand the rotating wire is unsheathed by connecting thecatheter to the handle [217]. Proper positioning of the metalball below the superior epigastric vein and saphenofemoralvalve is essential, and the wire can snag on either the veinwall or valve. Before the infusion of the sclerosant wirerotation is advised for 3 to 10 seconds to create a venospasmin the proximal GSV, followed by continued rotating andpullback with infusion of a sclerosant. The pullback speed is 6to 7 s/cm [218,219]. Compression stockings are usuallyadministered for 2 weeks after MOCA.Sotradecol and polidocanol can both be used as liquid

sclerosants. Sclerosant dosage can be obtained from a dosingchart supplied by the company, and depends on vein treat-ment length and vein diameter. The maximal sclerosantvolume depends on the patients’ weight when using polido-canol. Instructions for use include treatment with sotradecol1% for GSV and SSV, and 2% polidocanol for GSV and SSV[217]. When a tributary branch of the GSV is passed duringMOCA, pullback can be slowed and/or the infusion rate of thesclerosant can be increased in order to disperse sclerosantinto this branch. The collateral distribution of sclerosant intotributaries has a beneficial effect and reduces adjunctiveprocedures [220].

Table 3 – Published prospective studies of ultrasound-guided foam sclerotherapy.

Study Year Study design Follow-up (mo) No. of patients Occlusion rate (%)

Cabrera [182] 2000 Prospective 60 500 81Belcaro [183] 2003 RCT 120 211 49Hamel-Desnos [184] 2003 RCT 1 45 84Barrett [185] 2004 Prospective 23 100 97Yamaki [186] 2004 RCT 12 37 68Bountouroglou [187] 2006 RCT 3 29 79Darke [188] 2006 Prospective 2 220 74Smith [189] 2006 Prospective 6 459 88

82a

Wright [190] 2006 RCT 12 437 78.9Brodersen [191] 2007 Prospective 6 30 90Ceulen [192] 2007 RCT 12 40 80.1Hamel-Desnos [193] 2007 RCT 36 148 69Myers [181] 2007 Prospective 36 627 53

36a

Abela [194] 2008 RCT 1 27 96Gonzalez-Zeh [57] 2008 RCT 12 53 77O’Hare [195] 2008 Prospective 6 185 74Ouvry [196] 2008 RCT 24 47 53Rabe [197] 2008 RCT 3 54 69Chapman-Smith [198] 2009 Prospective 60 203 35Darvall [199] 2009 Prospective 12 92 91a

Figueiredo [200] 2009 RCT 6 27 78Gillet [201] 2009 Prospective 1 1,025 90Blaise [202] 2010 RCT 36 143 79Bradbury [203] 2010 Prospective 28 1,270 92

93a

Darvall [204] 2010 Prospective 12 333 93Nael [205] 2010 Prospective 6 217 64Thomasset [174] 2010 Prospective 3 126 79Li [206] 2011 Prospective 9 59 90Rasmussen [13] 2011 RCT 12 144 84Asciutto [168] 2012 Prospective 12 357 67Chen [207] 2012 Prospective 38 288 60Shadid [208] 2012 RCT 24 230 65Yamaki [209] 2012 RCT 6 51 45Biemans [93] 2013 RCT 12 77 72Lattimer [95] 2013 RCT 15 46 67Williamsson [169] 2013 Prospective 12 94 71Devereux [171] 2014 RCT 12 25 75



Contraindications for MOCA are pre-existent thrombus inthe treated vein, use of anticoagulants, and pregnancy. Thereis no evidence of treating larger GSV (412 mm) with MOCA.Manual compression is advised by the company over thelength of the treated vein whenever the vein diameter is 410mm to enhance mechanical damage to the vein wall.


MOCA combines mechanical damage to the endothelial layerusing a rotating wire with the infusion of a liquid sclerosant[221]. The aim of the mechanical damage is to promotecoagulation activation by damaging the endothelium; toinduce vasospasm, reducing the vein diameter; to increasethe action of the sclerosant, and to ensure an even distribu-tion of the sclerosant. The liquid sclerosant then produces

irreversible damage to the cellular membranes of the endo-thelium, 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 MOCAtreatment. Also, considerable damage of the media withcollagen changes was observed [222]. In an ex vivo study,the mechanical part of the ClariVeins catheter caused subtleand incomplete destruction of the endothelium withoutchanges to media or adventitia [223]. The additional effectof a sclerosant could lead to the preferred complete endothe-lial disappearance. However, histopathological studies ofMOCA supporting this hypothesis are lacking.

5.3. Outcome

In 2009, the first clinical study was performed by Elias andRaines and described 30 limbs treated with sotradecol. Total

Fig. 3 – (A) The ClariVeins system including ClariVeins handle and ClariVeins catheter. (B) Magnified view of the distalrotating, 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 6months and 97% at 2 years follow-up [219,224]. The reportedocclusion rates of prospective series are listed in Table 4 andvary between 87% and 97% [218–220,224–227]. The largestseries by Bishawi et al reported success in 94% of the 126patients treated with sotradecol as well as polidocanol [225].Interestingly, a difference in anatomical success of 87%versus 97% was observed 6 months after MOCA betweenpatients treated with polidocanol 1.5% and 2% [226]. In thisobservational study, 50 patients with insufficient SSVs wereincluded. A randomized study comparing MOCA with RFAreported similar occlusion rates of 92% after 4 weeks [227].

5.4. Complications

Because no heat is generated with MOCA, heat-related compli-cations, such as skin burn and paresthesia, will not appear.MOCA is associated with less postprocedural pain compared toRFA in the first 14 days after treatment, which also results in afaster recovery [227,228]. Other possible complications are com-parable with other endovenous techniques. Deep venous throm-bosis and pulmonary embolism have not been described afterMOCA, but are potential complications after all endovenousprocedures. Superficial thrombophlebitis occurs in 12% to 14%,which is comparable to UGFS [220,226].

Table 4 – Published prospective studies of mechanochemical e

Study Year Study design Fo

Van Eekeren [218] 2011 Prospective 2Elias [219] 2012 Prospective 6Bishawi [225] 2013 Prospective 6Boersma [226] 2013 Prospective 12Elias [224] 2013 Prospective 24Van Eekeren [220] 2014 Prospective 12Bootun [227] 2014 RCT 1


6. Endovenous steam ablation

6.1. Technique

Endovenous steam ablation (EVSA) is an endovenous techni-que that uses steam to heat the vein. EVSA can be performedin an outpatient setting with tumescence anesthesia. Venousaccess is obtained by a 16- or 19-gauge cannula or 5Frmicrointroducer set under ultrasound guidance. The steamablation catheter is advanced into the GSV and positioned 2to 3 cm below the SFJ [105,229]. As with other techniques,proper positioning of the echogenic tip of the catheter is themost essential step during the treatment. Application oftumescence anesthesia is similar to EVLA and RFA, anddecreases the venous diameter.In a special generator, pressurized sterile water is injected

into a microtube that is heated by electrical current. Theheated water is emitted at the tip of a hand piece as pulses ofsteam at 1501C. A catheter is connected to the steam-emittinghand piece and carries the steam into the vein through twolateral holes near the tip (Fig. 4). At the tip of the catheter, thetemperature decreases to 1201C. After activation, two pulsesof steam are delivered to dispel the condensated water fromthe catheter. Then, three pulses are released at the tip of the

ndovenous ablation.

llow-up (mo) No. of patients Occlusion rate (%)

30 8730 97126 9450 94a

29 97106 8860 92

Fig. 4 – (A) Steam generator. (B) FlexiVeinTM catheter with two radial opposite holes to emit steam at the distal portion. Usedwith permission of CermaVein (Archamps, France).


catheter to treat the most proximal GSV. The catheter ispulled down stepwise for segments of 1 cm, applying 2 to 4pulsed steam puffs/cm. The number of pulses depends on thevein diameter [105]. The same generator also allows theability to obliterate tributaries with a special designed cath-eter. After the procedure, compression stockings are usuallyadvised for 1 to 2 weeks.Relative contraindications for EVSA are comparable to

EVLA and include thrombus in the vein segment to betreated, immobility, severe arterial disease, deep vein throm-bosis, pregnancy, and patients who are breastfeeding.


EVSA utilizes the condensation of steam into water, whichreleases lots of energy in a short time and produces a thermaleffect on the vein wall. The steam condensates back to waterand the resulting heat is absorbed by the vein wall. One pulsehas a heating capacity of 60 J. Because the temperature ofsteam is delivered in a regulated temperature of 1201C, themechanisms of action are very similar to RFA. In vitrotemperature measurements of EVSA showed a longer plateauphase of heat and lower maximum temperature than EVLA,which was comparable to RFA [230]. In addition, temperaturesignificantly rises inside the vein when more pulses of steamare delivered.In an animal study, disappearance of the endothelium was

observed immediately after EVSA. This process was followed

Table 5 – Published prospective studies of endovenous steam

Study Year Study design Fo

Van den Bos [229] 2011 Prospective 6Milleret [232] 2013 Prospective 12Mlosek [233] 2014 Prospective 6Van den Bos [105] 2014 RCT 12

by fibrotic thrombosis, inflammatory reaction of the media,and eventually fibrosis of the treated vein [229,231].

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 occlusionof 65% at 6 months. The reported recanalization only affectedsegments o10 cm of the treated GSV. In a multicenter studytreating 88 veins with GSV insufficiency, success was 96.1%after 1-year follow-up [232]. The reported occlusion rates inprospective series are listed in Table 5 and vary between 65%and 96% [105,229,232,233]. A randomized controlled studycomparing 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 reportedsimilar results compared with EVLA.

6.4. Complications

Possible complications of EVSA are comparable with those ofEVLA and RFA. Paresthesia is observed in 2% after EVSA [105].No deep venous thrombosis or pulmonary embolism hasbeen reported. However, extension of the thrombus for 1cm in the deep femoral vein was observed, which disap-peared after low-molecular-weight heparin treatment [234].EVSA is associated with significant lower postprocedural painthan EVLA [105].

ablation.

llow-up (mo) No. of patients Occlusion rate (%)

20 6588 9620 95117 87


7. Discussion

The treatment of varicose veins has changed dramaticallyover the past years. Although high saphenous ligation withsurgical stripping has been the gold standard during most ofthe 20th century, endovenous techniques have replaced tradi-tional surgery as a result of similar efficacy, faster recovery,less postprocedural complications, and improved quality oflife [15]. Since the introduction of endovenous techniques,many prospective series and randomized studies have beenpublished on the efficacy of treatment. Unfortunately, moststudies are focused on technical feasibility and short-termoutcomes, while evidence of long-term outcomes is thriftily.Only a few studies have reported occlusion rates more than 5years after endovenous procedures [86,87,96,127,182,183,198].Long-term results of randomized controlled studies areneeded to provide an answer on the durability of endovenoustechniques, especially for newer techniques, such as MOCAand EVSA.Results of a recent meta-analysis and systematic Cochrane

review suggest that efficacy of EVLA, RFA, and UGFS isnonsignificantly different compared with surgery [15,235].However, heterogeneity in the definition of “efficacy” or“success” is a major problem in comparing results betweentechniques. Success and efficacy are often revealed as theabsence of recanalization, which varies from “no evidence offlow in the treated vein” to “flow in segments less than 15% ofthe total treated segment.” Therefore, standardization ofoutcome parameters after varicose vein ablation is necessaryto optimize comparison in the future [236].The most pivotal outcome of varicose vein treatment

should be the clinical outcome that is most important topatients. Clinical outcomes that are significant for patientsinclude the relief of symptoms, improvement in quality oflife, prevention of ulceration, and satisfaction with aesthetics.Deterioration of these patient-specific outcomes is normallyclinical expression of recurrence. However, ultrasound-proven occlusion rates are usually used as substitute forclinical recurrence, that disregards other causes of recur-rence, such as neovascularization, reflux in the GSV belowthe knee and tributaries [237].Several advantages and disadvantages can be summarized

from the current literature. EVLA and RFA report highocclusion rates, and UGFS often needs multiple treatmentsto achieve the same results. Mid-term efficacy of newerendovenous techniques, like MOCA and EVSA, are not yetdefined. All endovenous techniques are performed in out-patient setting. Major complications are rare and comparablebetween procedures [238]. Postprocedural pain is related tothe amount of heat that is released during treatment. RFA,UGFS, and EVSA have reported less postprocedural paincompared to EVLA [13,105,112]. MOCA is associated withsignificantly less postprocedural pain than RFA [228]. Anadvantage of UGFS and MOCA over endothermal techniquesis the omission of tumescence anesthesia, which is timeconsuming and needs multiple injections.Some considerations should be given to the cost-

effectiveness of endovenous procedures, while reimburse-ment for the treatment of varicose veins is not guaranteed in

several countries. Procedural costs of UGFS are lower thanwith EVLA and RFA, due to the use of disposable cathetersand a generator [13]. However, costs of treatment failures,adjunctive procedures of tributaries, and speed of recoveryare also important parameters influencing cost-effectiveness.In a systematic review, differences between these parameterswere negligible and cost-effectiveness is therefore associatedwith long-term clinical success of the treatment [239].This literature review aimed to describe the current per-

formance of endovenous techniques in the treatment ofvaricose veins. As a consequence of their potential advan-tages in patient’s comfort and low incidence of complica-tions, several evolutions are made in nonthermal ablation.New techniques as endovenous cyanoacrylate glue (Vena-sealTM Sapheon Closure System), ready-made low nitrogenfoam (Varithenas), and installation of an occlusion device incombination with liquid sclerotherapy (V-Blocks) have beendeveloped recently. These promising technologies were notincluded in this review because the level of clinical evidenceis low at this moment.In conclusion, all endovenous procedures for the treatment

of varicose veins are effective in abolishing reflux. More long-term results of clinical outcome parameters and costs areneeded to recommend a specific technique as the goldstandard in endovenous varicose vein treatment. Strategiesto obtain long-term clinical outcomes and patient satisfactionshould contain multimodal approaches, in which severaladvantages of techniques can be exploited.

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