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ndovascular Treatment of Varicose Veinsichael Stirling, MD and Cynthia K. Shortell, MD

Within the past 5 years, radiofrequency ablation and endovenous laser treatment havebeen introduced as important new endovenous ablative techniques for the minimallyinvasive treatment of superficial venous reflux and varicose veins. Although sclerotherapyhas been a well-established technique for spider telangectasia, recent reports have doc-umented that administration of aerated or foamed sclerosants provides an excellent cost-effective option for treatment of varicose veins. This report reviews the indications for theseminimally invasive techniques, the technical aspects of these approaches, and describes indetail the short and long-term success rates. To date, results of minimally invasive thera-pies are equivalent to or surpass those of surgical vein stripping, while offering dramaticallyreduced recovery time and complication rates.Semin Vasc Surg 19:109-115 © 2006 Elsevier Inc. All rights reserved.

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ANIFESTATIONS OF SUPERFICIAL venous reflux area common clinical problem, treated by a range of spe-

ialists. Patients present with a variety of findings, includingelangectasias, reticular varicosities, or true varicose veins.1

hey can occur primarily, or as a consequence of chronicenous insufficiency. Symptomatic varicose veins are presentn 15% of men and 25% of women2 and appear in two-thirdsf these patients by their third decade.1 Indications for treat-ent are varied (Table 1), with the most common complaints

eing lower extremity pain, fatigue, and heaviness thatorsen throughout the day. According to Bergan and Pas-

arella,3 the “true symptoms of venous insufficiency includeching tiredness and aching discomfort in the legs relieved byitting and leg elevation.”

Four main risk factors for development of varicose veinsave been identified: family history, female hormones, grav-

tational hydrostatic forces (exacerbated during pregnancy)nd hydrostatic muscular compartment force.1 Varicoseeins develop as a result of the hydrostatic and hydrody-amic forces acting in a susceptible vascular environment.The challenge facing healthcare providers is to provide an

ffective treatment for patients with superficial venous refluxhat is associated with a short recovery period, minimal mor-idity, low recurrence rate, and cosmetically satisfactory out-omes. The last several years have witnessed development ofinimally invasive techniques that approach these goals.

ivision of Vascular Surgery, Duke University Medical Center, Durham, NC.ddress reprint requests to Cynthia K. Shortell, Division of Vascular Sur-

gery, Duke University Medical Center, Box 3358, Durham, NC 27710.
(E-mail: [email protected]
895-7967/06/$-see front matter © 2006 Elsevier Inc. All rights reserved.oi:10.1053/j.semvascsurg.2006.03.008

istorical Backgroundistorically, the definitive treatment of varicose veins haseen surgical. If conservative treatment of varicosities failed,atients were offered high ligation and stripping of the greataphenous vein (GSV) and surgical removal of accessory var-cose veins. This approach is associated with a 20% rate ofecurrent varicosities at 5 years4 and up to 24% of patientsequiring additional treatment.5 The morbidity associatedith this technique, however, is noteworthy. Complications

nclude hematoma, infection, pain, scarring, and saphenouserve injury (4% to 7%).5 Furthermore, patients frequentlyequire 2 to 6 weeks off of work or daily activities to recover,ith an average sick leave of 4 weeks.6 As a result, younger,

ctive patients do not receive treatment because the pro-onged recovery time interferes with work and family, andlder patients do not receive treatment because the risks ofeneral or regional anesthesia are too great, and the recoverys too arduous.7 In general, treatment was reserved forealthy individuals with the most severe symptoms becausef the associated complications and long recovery time.

ndovascular Optionsor Varicose Veinsurrently, three endovascular techniques are used in the

reatment of superficial venous reflux by the majority of prac-itioners in the United States. Originally described in 1939,oam sclerotherapy8 has recently undergone modificationnd increased in popularity. In 1999, the US Food and Drugdministration approved radiofrequency ablation (RFA)

VNUS Closure; VNUS Medical Technologies, San Jose, CA),

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s a technique to obliterate refluxing superficial veins.9 Thisas followed by development and subsequent approval of

ndovenous laser treatment (EVLT) in 2002.10

echanism of Actionoam Sclerotherapyclerotherapy involves the deposit of a foreign substance intovessel lumen, which results in thrombosis and fibrosis.

clerosants cause endothelial damage, initiating this process.estruction of the endothelial layer and resulting exposure of

ubendothelial collagen leads to platelet aggregation and ac-ivation of the intrinsic pathway of coagulation.1 This, inurn, prompts endofibrosis, which ultimately ablates theein. When administered as foam, an air block is created thatisplaces the blood. This, combined with a larger surface areaf the sclerosant (in foam form) results in greater endothelialxposure to the sclerosant and increased treatment efficacy.10

he strongest sclerosing agents currently available are so-ium tetradecyl sulfate and polyiodinated iodine.9

FAith RFA, the vein wall is exposed to high-frequency alter-

ating current by direct contact of the catheter prongs withhe endothelium of the vein wall. This leads to loss of vesselall architecture, disintegration, and carbonization of theessel.11 Tissue destruction is precise and very little throm-us is created. The need for direct contact of the catheterrongs with the vein wall may limit the application of RFA toatients with veins smaller than 12 mm (Fig 1).

ndovenous Laser Treatmentpplication of endoluminal laser energy to the treatment ofuperficial venous reflux disease began to gain popularity inhe 1990s.12 EVLT delivers laser energy directly into the veinumen, but the mechanism of action by which this bringsbout destruction of the vein wall is debated. The laser energyauses the blood inside the vein to boil, and it may be theiffusion of the superheated steam bubbles to the vein wallhat actually destroys the vein architecture.13 Other authorsrgue that the heat generated by the steam bubbles is notufficient to destroy the vein wall, and that this requires di-ect contact with the laser energy itself.11 With either theory,he final common pathway is the same as that seen with RFA;

able 1 Varicose Veins: Indications for Intervention

General appearanceAching painLeg heavinessEasy leg fatigueSuperficial thrombophlebitisExternal bleedingAnkle hyperpigmentationLipodermatosclerosisAtrophie blancheVenous ulcer

rom Bergan.1 Reprinted with permission.

he heating of the vein wall results in collagen contraction u

nd destruction of endothelium. The vein wall thickens, con-racts, and the end result is fibrosis of the vein (Fig 2).13,15

ndications and Patient Selectionthorough history and physical exam should be performed

n all patients. This should include the length and nature ofymptoms and history of superficial or deep venous throm-osis (DVT) in the past, prior treatments undertaken, includ-

ng compression therapy, and overall health. If the patientas a personal or family history of thrombosis, considerationhould be given to additional investigation of this problem,nd possibly to perioperative anticoagulation therapy, if in-icated. Treatment should not be undertaken in the setting ofcute clot in the target vessel. Prior surgical treatmentshould be investigated, as they can influence the technicaluccess of endovenous therapy. Physical examination shouldeek to determine the status of the arterial system, presencer absence of signs of chronic venous insufficiency and stasis,

igure 1 VNUS Medical Tecnologies, Inc. device components foradiofrequency ablation. The Closure PLUS catheter possesses aicrothermocouple that continuously measures vein wall temper-

ture and provides feedback to the VNUS Radiofrequency Genera-or. Delivery of RF energy via the Closure electrodes (inset) causesesistive heating of the vein wall resulting in vein shrinkage andcclusion. Temperature, impedance, and power are continuouslyonitored for optimal performance.

igure 2 (A) The EVLT Laser Fiber is available in 45-cm (for knee-evel access) and 70-cm (ankle-level access) lengths and is passedhrough a 5Fr sheath. (B) The tip of the laser is easily visualized by
ltrasonography imaging.

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Endovascular treatment of varicose veins 111

nd size, location, and nature of the patient’s varicosities.uplex evaluation can be obtained before or after the initialonsultation. A thorough study must be undertaken of thentire lower extremity venous system, with particular atten-ion to associated reflux in the deep and perforator systemshat might adversely influence the results of the procedure. Inddition to the deep, perforator, and superficial systems, at-ention must be paid to veins, such as the anterior accessoryaphenous vein that may also serve as a source of reflux.

hen possible, it is helpful to determine the source fromhich the patient’s most symptomatic veins derive.Once the initial evaluation process is complete, preopera-

ive planning is initiated. The decision about which veins toreat, when, and in what order should be based on the factorsutlined above. In general the GSV is treated first, rather thanhe small saphenous vein (SSV), unless the symptomaticeins derive directly from the SSV and/or it is refluxing sig-ificantly more than the GSV. Significantly refluxingranches should be treated simultaneously. Several ap-roaches can be used with regard to treatment of associatedccessory veins. If the endovenous procedure is to be per-ormed in the office setting under local anesthesia, removal ofccessories is generally delayed to a later point, particularly asany will resolve spontaneously after vein ablation. If therocedure is to be performed under general or regional an-sthesia in the operating room, it may be preferable to simplyemove the accessory veins while the patient is under anes-hesia.

echniquesoam Sclerotherapyhe injection of sclerosants has been an effective treatment in

he therapy of varicose veins for many years. The first re-orted treatment was in 1840, with absolute alcohol used ashe sclerosant of record.11 Foam sclerotherapy combines airith approved sclerosants to create microfoam for injection.ltrasonography guidance is used to locate the target vein,hich is then injected with the sclerosant. Local anesthetic

an be used to decrease pain. There are two primary methodsf foam preparation available, Tessari and Monfreux. Bothethods result in some inconsistency in the foam prepared.9

The Monfreux method was described in 1997 with thereation of foam in a glass syringe. The syringe containing theclerosant has air drawn into it, creating foam containingarge bubbles. Variations in the foam are the result of type andoncentration of sclerosant, type of syringe, and method ofithdrawing piston of the syringe.9

The Tessari method has become one of the most popularechniques.14 Two syringes are attached to a three-way stop-ock, one containing air and the other containing sclerosant.he sclerosant is then passed back and forth between the twoyringes.9 Optimal foam is created after 20 passes, with aigher concentration of sclerosant resulting in more stableoam.14

The treated limb should be elevated in order to empty theuperficial venous system.11 Compression at the saphe-
ofemoral junction (SFJ) is used to prevent extension of scle- g
osant into deep venous system. This also aids in the preven-ion of microemboli (see complications below). Therocedure is completed with the placement of compressionressings.10

FAhe RFA catheter and generator are made by a single manu-

acturer and have a standardized application protocol.7 Theatient is placed in Trendelenburg, and the target vein is

dentified and accessed using ultrasonography guidance (ifecessary, a cutdown can also be used to access the vein).ccess is generally done at the level of the knee for the GSV,nd just above the ankle for the SSV. Once venous access isstablished, the patient position is switched to reverse Tren-elenburg position and the RFA catheter advanced to 0.5 to 1m inferior to the SFJ with the assistance of ultrasonography.he final position should be immediately inferior to the su-erficial epigastric vein.10 Tumescent anesthesia (a diluteixture of 1% lidocaine, epinephrine, and bicarbonate) is

njected subcutaneously along the length of the vein, takingare that it is placed within the saphenous sheath,10 andchieving a vein depth of at least 1 cm. The tumescent anes-hesia has a threefold purpose: analgesia, prevention of ther-al injuries to the skin (through its heat sink effect and byeepening the vein from the skin surface if necessary), andompression of the vein to improve contact between the en-othelium and catheter prongs. Two sizes of electrodes arevailable, 6Fr and 8Fr, which treat vessels up to 8 mm androm 8 to 12 mm, respectively. Larger vessels have beenreated successfully with adjunctive strategies including in-reased tumescent volume, Esmarch bandage application,xtreme Trendelenburg, and administration of tumescent so-ution superior to the SFJ. The temperature of the probe is sett 85°C, and, once equilibrated, withdrawn at a rate of 2.5 to.0 cm/minute.16 If the temperature is increased to 90°C, thepeed of electrode withdrawal can be increased to 4.0 cm/inute.10 During catheter withdrawal, temperature, imped-

nce, and generator output should be monitored, with theate of withdrawal adjusted accordingly.

After catheter withdrawal has been completed, the patients returned to a horizontal position, and ultrasonography iserformed to assess for patency of the common femoral veinnd superficial epigastric vein, and for success of closure. Ifhere is still spontaneous flow, the procedure can be re-eated. If flow is minimal and the vein walls are noted to behickened, a thrombus plug usually forms, resulting in ces-ation of flow.10 If a second pass of the catheter is unsuccess-ul, surgical ligation through a small incision just below theFJ may be elected.17 It is recommended that patients useompression therapy on the treated leg for approximately 1eek postprocedure, and that they walk daily. They can re-

ume normal activities immediately. Follow-up ultrasonog-aphy at 72 hours postprocedure is performed to confirmrocedural success and ensure no proximal clot extension

nto the femoral vein has occurred.

VLTVLT has short exposure time with maximal ablation of tar-
eted tissue. Similar to RFA, the patient is placed in reverse

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rendelenburg and ultrasonography guidance is used to ac-ess the GSV at the knee. A 5Fr introducer sheath is placed inhe vein.13 Patient position is converted to Trendelenburgnd a 600-�m fiber is then positioned approximately 1 cmnferior to the SFJ to deliver laser energy at 810 nm. Wave-engths other than 810 nm (940, 980, and 1,320 nm) havelso been used successfully.9 Tumescent anesthetic is thennjected subcutaneously along the course of the GSV as withFA. The location of the device tip is confirmed by ultra-onography and visualization of the red aiming beamhrough the skin.9,13 The device is turned on and withdrawnelatively rapidly (3 mm/minute). Manual compression of theein aids with obliteration of the lumen.10 As with RFA, afterhe procedure patients wear a full-thigh 30 to 40 mm Hgraduated compression stocking for 1 week,13 undergo fol-ow-up ultrasonography at 72 hours, and walk daily, resum-ng normal activities immediately after the procedure.13

utcomesoam Sclerotherapy3-year study from Italy included 453 patients treated with

oam sclerosant. Using the Monfreux and Tessari methods ofoam preparation, immediate success was 88.1% and 93.3%,espectively.18 In France, 88 patients were randomized in arospective, multicenter study to compare foam with liquidclerosant. In the foam group, GSV reflux was absent in 84%t 3 weeks, and at 6 months there were only two recanaliza-ions. At 12 months, there were no additional recanaliza-ions.19

FAFA has been recorded in a prospective, multicenter registry.eview of 890 patients (1,078 limbs) was attempted at 1eek, 6 months, and 1, 2, 3, and 4 years. The number of

imbs evaluated at each time interval was 858, 446, 384, 210,14, and 98, respectively. The vein occlusion rates were1.0%, 88.8%, 86.2%, 84.2%, and 88.8%, respectively.20 A

able 2 Short-Term Success Rates of Endovenous Therapies

Reference, Year Therapy n S

erchant et al,28 2002 RFA 319 ingorani et al,26 2004 RFA 73 hortell et al,17 2005 RFA 335 in et al,13 2003 EVLT 499 abrera et al,19 2000 Foam 500

bbreviations: CFV, common femoral vein; EVLT, endovenous lasvenous thromboembolism.

able 3 Intermediate and Long-Term Success Rates of Endov

Reference, Year Therapy n Follow

urie et al,21 2005 RFA 65 erchant et al,20 2005 RFA 1,078 in et al,13 2003 EVLT 499 abrera et al,19 2000 Foam 500

bbreviations: EVLT, endovenous laser treatment; NR, data not reported;

ingle-center retrospective review of 332 limbs demonstratedomplete GSV obliteration at 72 hours in 99% of cases.17 In arospective, randomized comparison of RFA and ligationith stripping (EVOLVeS), the 2-year clinical results demon-

trated RFA to be at least the equivalent of surgery for GSVbliteration and that quality-of-life scores were higher at 2ears in the RFA group.21

VLTVLT has also shown excellent results in early GSV oblitera-

ion rates. A retrospective review of 92 consecutive patients130 limbs) at the Mayo Clinic demonstrated a reinterventionate of 0% in EVLT (v 17% in RFA) and immediate GSVcclusion of 100%.22 These results exceeded a larger trialncluding 499 limbs in 423 patients, which documented im-

ediate GSV occlusion rate of 98.2% (490 of 499) and a-year success rate of 93.4% (113 of 121 followed at 2ears).13 An earlier report from the same author had a-month success rate of 99%.23 These results have been ap-roached by other authors with smaller sample sizes, includ-

ng a study of 29 patients with a 1-month success rate of7%.24 Comparative outcomes are summarized in Tables 2nd 3.

omplicationsoam Sclerotherapyhe complications of foam sclerotherapy are predominantlyinor and resolve spontaneously. Clot extension beyond the

FJ occurs rarely.3 In a prospective trial of large-volume scle-otherapy, no symptomatic limbs were found to have DVT.7

ore serious complications result from extraluminal injec-ion. Perivenous injection results in local ulceration and in-raarterial injection will result in arterial occlusion. If thisccurs in a major vessel, distal limb ischemia can result.25

lthough severe, these complications are rare.11

Much has been made of the potential consequences of

ss (%) VTE (%) CFV Clot Extension (%)

3 1.5 06 1.4 158 0.7 29 0 NR6 0 NR

tment; NR, data not reported; RFA, radiofrequency ablation; VTE,

Therapies

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RFA, radiofrequency ablation.

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icroembolization of foam particles, despite the fact that nolinically significant adverse event has ever been attributed tohis in the literature. Pulmonary effects of treatment haveeen studied in canine models. There is transient pulmonaryypertension (15 minutes) and decreased systolic bloodressure of 10 to 20 mm Hg without adverse effects.14 Be-ause of these and other potential side effects, including dryough, chest pain, transient ischemic attacks, and scotomas,ccepted dosing regimens range from 3 mL to 80 mL perreatment.14

FAomplications of RFA treatment include focal paresthesia,VT, pulmonary embolus (PE), phlebitis, infection, and skinurns. In their 4-year review, Merchant et al20 recorded par-sthesia rates of 12.1% at 1 week, 6.7% at 1 month, and 2.0%t 4 years. They also noted the incidence at 1 week was lessith the implementation of tumescent anesthesia and atigh-volume centers.20 In a recent retrospective review fromhe Mayo Clinic, 17% of patients undergoing RFA requireddditional treatment at the time of initial procedure, com-ared with virtually none with EVLT.22

Both localized thrombus at the SFJ and DVT occurred in.5% of patients. Of these, one patient developed a PE.20 Inontrast, Hingorani et al26 found a DVT rate in their treat-ent group of 16%. They had no events of PE.26 Merchant et

l20 found a skin-burn rate of 1.7% in the absence of tumes-ent anesthesia and 0.5% with its use.20 Phlebitis was re-orted at 3.3% at 1 week and 0.2% at 6 months.20

able 4 Complications of Endovenous Therapies*

1 Week

RFA(%)

EVLT(%)

Foam(%)

RF(%

ematoma 5 15 7 0nduration 8 25 0 0ysesthesia 15 20 0 9hermal injury 2† 2 0 0dema 1 18 4 0isual 0 0 .5-1 0

bbreviations: EVLT, endovenous laser treatment; RFA, radiofrequeComposite data.Incidence confined to early experience.

able 5 Relative Incidence of Venous Thromboembolic Event

Reference, Year Modality n

erchant et al,28 2002 RFA 319 urie et al,29 2003 RFA 86 hortell et al,17 2005 RFA 335 in et al,13 2003 EVLT 499 nastasie et al,30 2003 EVLT 232 abrera et al,19 2000 Foam 500 uggioni et al,22 2005 RFA 77

EVLT 53

bbreviations: CFV, common femoral vein; EVLT, endovenous laser treatm

In a comparison of patients consecutively treated by RFAnd subsequently EVLT, the Mayo Clinic group22 observed areater incidence of immediate complications, which rangedrom excessive pain to urinary retention, in the EVLT group16.8%) than the RFA group (7.6%). They identified areater need for reintervention for adequate GSV closure inhe RFA group (17%) versus the EVLT group (0%).22

hether the necessity of a second passing of the devicehould be considered a complication is left to the discretionf the reader.

VLThe most common complaint with EVLT (90%) is a sensationf “pulling” along the course of the ablated vein.13 This re-olved in all patients in 3 to 10 days.13 Thrombophlebitis andigmentation changes are the next most common complaint,ut also do not require intervention. In their series of 504reated limbs, Min et al13 recorded bruising in 24% at 1 weekall resolved at 1 month) and superficial thrombophlebitis in%. They reported no skin burns, paresthesias, DVT, or PE13

Tables 4 and 5).A retrospective analysis at the Mayo Clinic reported exten-

ion of thrombus into the femoral vein at 2.3%.22 These pa-ients were asymptomatic and thrombus extension discov-red at follow-up ultrasonography. One patient requiredlacement of an inferior vena cava filter.22 All clots resolved atltrasonography follow-up over 2 to 12 weeks during theourse of anticoagulation treatment.22

6 Months 1 Year

EVLT(%)

Foam(%)

RFA(%)

EVLT(%)

Foam(%)

0 0 0 0 02 0 0 0 03 0 4 0 00 0 0 0 00 0 0 0 00 0 0 0 0

lation.

Deep VeinThrombosis

n %

CFV ClotExtension

n %

PulmonaryEmbolism

n %

31 0 10.30 0 0

20.7 42 00 NR 0

20.9 NR 0NR NR 00 0 00 32.3 0

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ent; NR, data not reported; RFA, radiofrequency ablation.

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iscussionith the advent of endovenous therapies for superficial re-

ux, older surgical therapies may be virtually obsolete. Itemains unclear which, if any, of the newly available en-ovenous therapies is best, as there are very few trials com-aring these therapies, and none are randomized and pro-pective. As should be clear from the information outlined inhe sections preceding, there are pros and cons to each mo-ality, and knowledge of these will help the practitioner tohoose between them. Ideally, all options would be availablen any given practice, and then treatment selection can beailored to individual patients’ needs. In many cases, how-ver, this is not practical because of the expense of the equip-ent involved.The advantages of RFA include the fact that any discomfort

s well tolerated by the patient, both during and after therocedure. Additionally, data regarding short and long-termafety and efficacy is very reliable because of the consistencyf technical performance and reporting standards. The dis-dvantages of RFA compared with EVLT and foam includelow pull-back time, relatively frequent need for a secondatheter pass, high rate of additional treatments that might beeeded, and relative difficulty in treating larger veins. EVLT,y contrast, has a very high immediate success rate and fastull-back rate, but is associated with more short-term com-lications, such as pain, edema, and bruising. With regard tooam sclerotherapy, the advantages are technical ease andow cost of the procedure, absence of short-term local com-lications, and apparently equivalent short and long-termuccess rates. Use of foam has been hampered, however, byoncerns over microemboli, the clinical significance of whichas not been proven, and concerns over availability and prep-ration of the sclerosing agents.27

onclusionsll three endovenous ablative techniques have demonstratedhort and long-term success rates equivalent or surpassinghose of surgical vein stripping, while offering dramaticallyeduced recovery time and complication rates. It is clear thatigh ligation and stripping is no longer the treatment ofhoice for superficial venous reflux. Comparing endovenousptions is difficult, however, as prospective, randomized tri-ls comparing these methods have not been performed.verall, results appear to be comparable among the thera-ies. However, without doubt, definitive treatment can nowe provided to a wider range of patients, given the reducedorbidity and recovery time offered by these new tech-iques. The method holding the most promise may be foamclerotherapy; it is less costly to administer than RFA orVLT, yet has similar efficacy.

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