Multi-society Consensus Quality Improvement Guidelines for the Treatment of Lower- extremity Superficial Venous Insufficiency with Endovenous Thermal Ablation from the Society of Interventional

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Multi-society Consensus Quality ImprovementGuidelines for the Treatment of Lower-extremity Superficial Venous Insufficiencywith Endovenous Thermal Ablation fromthe Society of Interventional Radiology,Cardiovascular Interventional RadiologicalSociety of Europe, American College ofPhlebology, and Canadian InterventionalRadiology AssociationNeil M. Khilnani, MD, Clement J. Grassi, MD, Sanjoy Kundu, MD, FRCPC, Horacio R. DAgostino, MD,

Arshad Ahmed Khan, MD, J. Kevin McGraw, MD, Donald L. Miller, MD, Steven F. Millward, MD,Robert B. Osnis, MD, Darren Postoak, MD, Cindy Kaiser Saiter, NP, Marc S. Schwartzberg, MD,Timothy L. Swan, MD, Suresh Vedantham, MD, Bret N. Wiechmann, MD, Laura Crocetti, MD, John F. Cardella, MD, and Robert J. Min, MD, for the Cardiovascular Interventional Radiological Society of Europe,American College of Phlebology, and Society of Interventional Radiology Standards of Practice Committees

J Vasc Interv Radiol 2010; 21:1431

Abbreviations : CEAP clinical status, etiology, anatomy, and pathophysiology [classification], CVD chronic venous disorder, DVT deep vein thrombosis,EVTA endovenous thermal ablation, GSV great saphenous vein, HL/S high ligation and stripping, RF radiofrequency, SSV small saphenous vein,SF-36 Short Form36, SFJ saphenofemoral junction, SPJ saphenopopliteal junction, SVI superficial venous insufficiency, VCSS venous clinical sever-ity score, VSS venous severity score

PREAMBLE

LOWER-extremity chronic venous dis-order (CVD) is a heterogeneous medicalcondition whose spectrum ranges fromvisually apparent abnormalities includ-ing varicose veins and spider telangiec-tasias with or without associated symp-toms to severe edema, skin ulceration,

and subsequent major disability. Ve-nous hypertension caused by incom-petent valves in the superficial veins is by far the most common cause of thiscondition. The incompetent valves aremost often found in the great saphe-nous vein (GSV) or small saphenousvein (SSV) or in their tributaries. Untilrecently, the main treatment strategy

for incompetence in these veins was toremove them. Endovenous thermalablation (EVTA) of the saphenousveins has been used by physicianssince the late 1990s as an alternative tosurgical removal. This document willreview the appropriate means bywhich the ablative techniques are to beused to maximize benefit and mini-

From Cornell Vascular (N.M.K.) and the Depart-

ment of Radiology (R.J.M.), New York PresbyterianHospitalWeill Cornell Medical Center, New York,New York; Department of Radiology (C.J.G.), LaheyClinic Medical Center, Burlington; Department of Radiology (J.F.C.), Baystate Health System, Spring-field, Massachusetts; The Vein Institute of Toronto(S.K.), Toronto; Department of Radiology (S.F.M.),University of Western Ontario, London; Depart-ment of Radiology (S.F.M.), Peterborough RegionalHealth Centre, Peterborough, Ontario, Canada; De-partment of Radiology (H.R.D.), Louisiana StateUniversity Health Sciences Center, Shreveport,Louisiana; Department of Interventional Radiology(A.A.K.), Washington Hospital Center; Departmentof Radiology and Radiologic Sciences (D.L.M.), Uni-formed Services University of the Health Sciences;Department of Radiology (D.L.M.), National Naval

Medical Center, Bethesda, Maryland; Department of

Interventional Radiology (J.K.M.), Riverside Meth-odist Hospital, Columbus, Ohio; RADIA (R.B.O.),Everett, Washington; Vascular and InterventionalRadiology (D.P.), University of Florida; Vascularand Interventional Physicians (B.N.W.), Gainesville;Radiology Associates (C.K.S.), Pensacola; RadiologyAssociates of Central Florida (M.S.S.), Leesburg,Florida; Department of Radiology (T.L.S.), Marsh-field Clinic, Marshfield, Wisconsin; Department of Radiology (S.V.), Mallinckrodt Institute of Radiol-ogy, Washington University School of Medicine, St.Louis, Missouri; University Division of DiagnosticImaging/Intervention, Department of Hepatology/Liver Transplantation (L.C.), Cisanello Hospital,Pisa, Italy. Received December 18, 2008; final revi-sion received and accepted January 5, 2009. Addresscorrespondence to N.M.K., c/o Debbie Katsarelis,

3975 Fair Ridge Dr., Suite 400 N., Fairfax, VA 22033;

E-mail: [email protected] of the authors have identified a conflict of interest.

This document was prepared by the standards com-mittee of the Society of Interventional Radiology(SIR). After completion, the document was pre-sented to the Cardiovascular and Interventional Ra-diological Society of Europe and American Collegeof Phlebology, which made recommendations andoffered their endorsement for this standard of prac-tice position statement.

SIR, 2010

DOI: 10.1016/j.jvir.2009.01.034

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mailto:[email protected]:[email protected]


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mize risk of complication for the pa-tients on whom they are employed.

The membership of the Society of In-terventional Radiology (SIR) Standardsof Practice Committee represents ex-

perts in a broad spectrum of interven-tional procedures from both the privateand academic sectors of medicine. Gen-erally, Standards of Practice Committeemembers dedicate the vast majority of their professional time to performing in-terventional procedures; as such theyrepresent a valid broad expert constitu-ency of the subject matter under consid-eration for standards production.

Technical documents specifying theexact consensus and literature reviewmethodologies as well as the institu-tional affiliations and professional cre-

dentials of the authors of this documentare available upon request from SIR,3975 Fair Ridge Dr., Suite 400 North,Fairfax, VA 22033.

METHODOLOGYSIR creates its Standards of Practice

documents with use of the followingprocess. Standards documents of rele-vance and timeliness are conceptualized by the Standards of Practice Committeemembers. A recognized expert is iden-tified to serve as the principal author,

with additional authors assigned de-pending on the projects magnitude. Anin-depth literature search is performedwith use of electronic medical literaturedatabases. A critical review of peer-reviewed articles is performed with re-gard to the study methodology, results,and conclusions. The qualitative weightof these articles is assembled into anevidence table, which is used to writethe document such that it contains evi-dence-based data with respect to con-tent, rates, and thresholds. When the ev-idence of literature is weak, conflicting,or contradictory, consensus for the pa-rameter is reached by a minimum of 12Standards of Practice Committee members with use of a modified Delphi con-sensus method. For thepurpose of thesedocuments, consensus is defined as 80%participant agreement on a value or pa-rameter.

The draft document is critically re-viewed by theStandardsof Practice Com-mitteemembers in either a telephone con-ference call or face-to-face meeting. Therevised draft is then sent to the SIR membership for further input/criticism duringa 30-day comment period. These com-

ments are discussed by the Standards of Practice Committee members and appro-priate revisions are made to create the fin-ished Standards document. Before itspublication, the document is endorsed by

the SIR Executive Council.The current guidelines are written to be used in quality improvement pro-grams to assess thermal ablation of lower-extremity superficial venous insuf-ficiency (SVI). The most important ele-ments of care are (i) pretreatment evalua-tion andpatient selection, (ii) performanceof the procedure, and (iii) postproceduralfollow-up care. The outcome measures orindicators for these processes are indica-tions, success rates, and complicationrates. Although practicing physiciansshouldstrive to achieve perfect outcomes,

in practice all physicians will fall short of idealoutcomesto a variableextent. There-fore, in addition to quality improvementcase reviews conducted after individualprocedural failures or complications, out-come measure thresholds should be usedto assess treatment safety and efficacy inongoing quality improvement programs.For the purpose of these guidelines, athreshold is a specific level of an indicatorthat, when reached or crossed, shouldprompt a review of departmental policiesand procedures to determine causes andto implement changes, if necessary.

Thresholds may vary from those listedhere; for example,patient referral patternsand selection factors may dictate a differ-ent threshold value for a particular indi-cator at a particular institution. The valueof thresholds is the establishment of a benchmark that can take into account both operator experience and complexityof the case. Therefore, setting universalthresholds is very difficult and each de-partment is urged to adjust the thresholdsas needed to higher or lower values tomeet its specific quality improvementprogram situation.

The SIR is committed to the basicprinciples of outcomes-focused, evi-dence-based medicine. Ideally, everyStandards of Practice Committee recom-mendation would be based on evidencederived from multiple prospective ran-domized trials of adequate statisticalpower. Unfortunately, there currentlyare only a limited number of small pub-lished randomized trials that evaluateEVTA in comparison with conventionalsurgery. That is in part because the areaof endovascular venous treatment is inevolution. The majority of the reports inthe literature include clinical outcomes

and proof-of-concepttype publications.In evaluating the existing publications,several major limitations are evident:(i) extreme variation in definitions of short-term efficacy and of complica-

tions; (ii) reliance on surrogate measuresof treatment success instead of scientifi-cally rigorous assessment of clinicallymeaningful outcomes; and (iii) absenceof systematic assessment of long-termefficacy.

The SIR recognizes the potential pit-falls of developing evidence-basedEVTA standards and of making recom-mendations regarding the use of thesedevices.

INTRODUCTION: EVTA OFTRUNCAL VEININCOMPETENCE

Throughout this document, the pro-cedure under discussion will be referredto as EVTA for incompetent truncal (ie,saphenous) veins. This procedure isused to ablate incompetent truncalveinsin patients with SVI. The underlyingmechanism of this procedure is to de-liver sufficient thermal energy to thewall of an incompetent vein segment toproduce irreversible occlusion, fibrosis,and ultimately resorption of the vein.The currently available devices used toaccomplish this have been evaluatedand approved by the Food and DrugAdministration of the United States anduse radiofrequency (RF) or laser energy(of a variety of different wavelengths) todeliver the required thermal dose. Thethermal energy is delivered by a RFcatheter or a laser fiber inserted into thevenous system, either by percutaneousaccess or by open venotomy. The proce-dure is generally performed on an ambulatory basis with local anesthetic andtypically requires no sedation. The pa-

tients are fully ambulatory followingtreatment and therecovery time is short.These guidelines are intended for use

in quality improvement programs that as-sess EVTA to insure the standard of careexpected of all physicians who performthis procedure. The processes to be mon-itored include (i) patient selection, (ii) per-formance of the procedure, and (iii) post-procedural follow-up. Assessment of outcome measures is also desirable, andthese include technical success, complica-tions,efficacy,andrecurrence rates,whichareassigned thresholdlevelsbased on thecurrently available data.

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DEFINITIONS

Anatomy

Superficial veins.The veins of thelower extremity that are superficialto the fascia surrounding the muscu-lar compartment are considered thesuperficial veins. These include in-numerable venous tributaries knownas collecting veins, as well as theGSV and SSV and their major namedtributaries ( Fig ).

Deep veins.The deep veins arethose that are found deep to the muscu-lar fascia. These include the tibial, pero-neal, popliteal, femoral, and iliac veins,as well as the intramuscular sinusoidaland perforating veins.

GSV .An important component of the superficial venous system, the GSV begins on the dorsum of the foot and as-cends along the medial aspectof the leg toultimately drain into the femoral veinnear the groin crease. This vein resides ina space deep to the superficial and super-ficial to the deep fascia. This location isknown as the saphenous space.The wordgreat replaces greater or long byinternational consensus ( 1,2; Fig).

SSV .Another important superfi-cial vein, the SSV begins on the lat-eral aspect of the foot and ascends upthe midline of the calf. In as many astwo thirds of cases, it drains into thepopliteal vein, and in at least onethird of cases more cephalad into theposterior thigh. The SSV also residesin the saphenous space. The wordsmall replaces lesser o r short by international consensus ( 1,2; Fig ).

Anterior and posterior accessory GSVs.The anterior and posterior accessoryGSVs are located in the saphenousspace and travel parallel and anterior orposterior to the GSV. The anterior a cces-sory GSV is much more common ( Fig).

Giacomini vein.This intersaphe-nous Giacomini vein is a communica-tion between the GSV and SSV. It rep-resents a form of SSV thigh extensionthat connects the SSV with the posteriorcircumflex vein of the thigh, a posteriortributary of the proximal GSV ( Fig).

Truncal veins.This term truncalveins refers to thesaphenous veins andtheir intrafascial straight primary tribu-taries ( Fig).

Disorders

Venous reflux.Veins contain valvesthat direct blood flow in one direction.

Usually, this is from the foot toward theheart and fromthe skin toward the mus-cles. When the valves fail, blood canflow retrogradely, and such flow is de-fined as reflux. Clinically significant re-flux in truncal veins lasts for greaterthan0.51.0 seconds following release of

compression on the muscular mass be-low the vein itself.Venous obstruction.Obstruction of

venous segments will impede venousdrainage and can lead to venous hyper-tension. Thrombosis is the most com-mon cause of acute venous obstruction.Such thrombosis can lead to permanentocclusion or partial or complete recana-lization with or without valvular incom-petence in that vascular segment.

CVD.CVD is the clinical entity thatresult s from chronic venous hyperten-sion (3). The overwhelming majority of patients with stigmata of venous hyper-tension have primary (or idiopathic)disease of the vein wall with resultantvalvular dysfunction in the superficialveins, which leads to reflux ( 4). Thissubset of CVD is known as SVI. Patho-physiologically significant reflux in theGSV or one of its primary tributaries ispresent in 70%80% of patients withCVD. SSV reflux is found in 10%20% of patients and nonsaphenous superficialreflux is identified in 10%15% of pa-tients ( 5,6). Venous obstruction, deepvein reflux, muscular pump failure, andcongenital anomalies are much less

common causes. Venous obstruction isthe most common of these other causesof CVD and is almost always the resultof prior deep vein thrombosis (DVT). Itis initially an obstructive disease butusually progresses to a combination of obstruction and superficial and deep re-

flux (7). Reflux or outflow vein obstruc-tion leads to an increase in pressure inthe veins. The veins themselves can di-late if unconstrained, and the pressurecauses stretching of receptors in the veinwall that leads to discomfort to the pa-tient. The pressure itself can adverselyaffect local tissues and metabolic pro-cesses, leading to damage in the veinwall, the skin, and subcutaneous tissues.

Neovascularization .Neovascular-ization is a term that describes the pres-ence of multiple small tortuous connec-tions between the saphenous stump orthe femoral vein and a residual saphe-nous vein or one its patent tributariesthat can occur following surgical liga-tion of the saphenofemoral junction(SFJ) or less commonly the saphenopo-pliteal junction (SPJ). This is a very com-mon pattern of recurrence followingsurgical ligation of the GSV and its trib-utary veins near the SFJ and presents asa tangle of blood vessels in the vicinityof the SFJ (8).

Clinical status, etiology, anatomy, and pathophysiology (CEAP) classification.CEAP is an acronym for a descriptiveclassification system that summarizes

Figure. Superficial truncal veins of the lower extremity.

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the dis ease state in a given patient withCVD (4,9). The system describes theclinical status, etiology, anatomy, andpathophysiology of the problem. Theclinical status scale is the most fre-quently used component, grading pa-tients based on p hysical o bservations of disease severity ( Table 1 ).

The venous severity score (VSS) is anadditional meansofgrading thespectrumof disease severity ( 10). The VSS allowsmore detailed description of the severityof attributes of CVD compared with theCEAP system. The VSS is the sum of scores of the following clinical classifica-tion systems: Venous Clinical SeverityScore (VCSS), Venous Segmental DiseaseScore (VSDS), and Venous DisabilityScore (VDS). The VSS is an importantcomplement to CEAP in reportingclinicalsuccess of an intervention.

Treatment Methods

EVTA.EVTA refers to the proce-dure by which thermal energy is en-dovenously delivered to the wall of avein with the goal of causing the veinsto irreversibly occlude and ultimatelyfibrose. It is usually employed to elimi-nate incompetent superficial truncalveins responsible for the manifestationsof SVI. The associated varicose tribu-tary, reticular veins, and telangiectasiasare treated separately with adjunctivetherapies including microphlebectomyand compression sclerotherapy.

Sclerotherapy.Sclerotherapy is aprocedure by which a medication is in-

jected into a vein to irreversibly occludeit. This is usually done with a syringeand needle, although these medicationscan be injected with a catheter or intra-venous cannula.

Microphlebectomy.Also known asambulatory or stab phlebectomy, mi-crophlebectomy is a procedure bywhich varicose tributaries are removedwith small hooks through 34-mm skinnicks with use of only local anesthetic.

Duplex ultrasound (US) .Duplex USis the most important imaging test toinvestigate patients with CVD. It usesgrayscale imaging to visualize the ve-nous anatomy and evaluate patency.Color and pulse-wave Doppler imag-ing is used to investigate direction andvelocity of blood flow through the

veins to identify reflux. Duplex US toevaluate CVD is much more compli-cated and time-consuming than to de-tect DVT, as it also involves the anal-ysis of segmental competence as wellas patency of all the deep, superficial,and perforator veins.

Tumescent anesthesia.Tumescentanesthesia refers to the delivery of largevolumes of dilute local anesthetic agentto cause a large region of anesthesia.This form of delivery typically causes aswelling, leading to the use of the termtumescent. Popularized by plastic

surgeons, this concept has been used inthe treatment of veins by delivering theanesthetic solution perivenously. ForEVTA, the perivenous delivery of thissolution is optimized by real-time USguidance.

Reporting Nomenclature

Anatomic success of EVTA.Ana-tomic success of EVTAis defined as per-manent occlusion of the entire treatedvein segment. Duplex US is essential todocument the anatomic success of EVTA. In the case of treatment to theSFJ, the segment of vein between the SFJand epigastric or other large junctionalvein usually remains patent. A partiallyoccluded vein is one with reflux beyondthe junction but with no reflux beyond 5cm from that point.

Anatomic success.Anatomic suc-cess is demonstrated on duplex US fol-low-up beyond 1 year. A successfullytreated vein segment will either be oblit-erated and difficult to find or will be athin echogenic structure on duplex USand have no flow.

Anatomic failure.Anatomic failure

of EVTA is defined as patency with orwithout reflux in greater than a 5-cmsegment of treated truncal vein beyondthe junction or initiation of treatmentpoint after EVTA as documented by du-

plex US. Anatomic failure describes sit-uations when the vein never occludesafter ablation or when it is found oc-cluded on short-term follow-up but re-canalizes at some point later.

Anatomic failure with this definitiondoes not include reflux identified in aparallel vein such as the anterior acces-sory GSV after EVTA occlusion of thetargeted vein. Such reflux was usuallypresent before the EVTA or representsprogression of disease. However, it isrecognized anecdotally that disease pro-gression in a parallel vein can be has-

tened after successful EVTA if its low-pressure outflow tributary varicositiesare not eliminated. Patency of theseveins may induce reflux in the parallelvein that may have been competent andpreviously served as the outflow veinfor the varicosities before EVTA.

Recanalization.Recanalization is de-fined as the process by which a previ-ously occluded vein, documented byduplex US, regains patency. Recanali-zation almost always is the result of aninsufficient thermal dose delivered tothe vein wall.

Primary ablation.Primary ablationdenotes anatomic success after initialtreatment.

Primary assisted ablation.Primaryassisted ablation denotes segmental re-canalization after initial thermal abla-tion, resulting in anatomic success aftertreatment by injection of sclerosant.

Secondary ablation.Secondary abla-tion denotes recanalization after initialtreatment, resulting in anatomic successafter treatment by a repeat procedurewith the same modality.

Clinical success.Clinical success is

defined as an improvement in the clini-cal status of a patient as defined by oneof the objective assessment instruments,such as the CEAP or VSS classification, by at least one grade. In practice, mostpatients treated with EVTA will also betreated with adjunctive microphlebec-tomy or compression sclerotherapy. It isgenerally believed that clinical successwill be dependent on the thoroughnessof the adjunctive procedures that areperformed, as well as the success of theEVTA. Therefore, for the purpose of de-fining success, most clinical reviews useanatomic success of EVTA.

Table 1CEAP Classification

Class Description

C0 No visible or palpable signs of venous disease

C1 Telangiectasias or reticularveins

C2 Varicose veins, distinguishedfrom reticular veins by adiameter 3 mm

C3 EdemaC4 Changes in skin and

subcutaneous tissueC4a Eczema, pigmentation (and

additionally coronaphlebectasia)

C4b Lipodermatosclerosis oratrophie blanche

C5 Healed venous ulcer

C6 Active venous ulcer



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and deep veins. The evaluation shouldalso include an assessment of the pa-tency of the femoral and popliteal veins.

The necessary equipment includesgrayscale US and pulse-wave Doppler

imaging using frequencies of 7.510Mhz, although higher and lower fre-quencies may be used depending on thepatients morphology. Color Dopplerimaging is very useful and readily avail-able as a package with most duplex USunits.

Duplex US should be performed inthe standing position and the examinershould thoroughly evaluate the GSV,SSV, their named tributaries, and thedeep veins for both reflux and obstruc-tion. Venous reflux is diagnosed whenthere is reversal of flow from the ex-

pected physiologicl direction for morethan 0.5 seconds following a provoca-tive maneuver to create physiologicflow. These include calf or foot com-pression by the examiner, dorsiflexion by the patient, or a Valsalva maneuverto assess for competency of the SFJ. Astandardized report should be createdand used to describe the findings foreach examination. The use of diagramssignificantly enhances the dissemina-tion of important clinical findings.

In a few clinical situations, patientsmay require further imaging to charac-

terize venous obstruction, reflux, or ve-nous anomaly in the pelvis or lower ex-tremity such as conventional ascending,computed tomographic (CT), or mag-netic resonance venography. Rarely pa-tients require a conventional catheter,CT, or MR arteriogram to evaluate forthe possibility of an arteriovenous mal-formation. Following clinical and imag-ing evaluation, thepatients clinical stateshould be summarized as to the sever-ity, cause, anatomic location and patho-physiology using the CEAP classifica-tion system.

Indications for EVTA

Patients seeking treatment of CVDcan be divided into those in whom it ismedically indicated and those in whomit is restorative (ie, cosmetic). The greatmajority of patients with CEAP class C2or higher CVD have symptoms, andtreatment is medically indicated to im-prove QOL. For a smaller subset of pa-tients, derangements in the health of theskin in the vulnerable medial ankle andcalf regions will represent medical indi-cations for treatment.

It is generally believed that reflux in

truncal veins must be treated before ad-dressing any visible abnormalities.However, there is some debate whethersome forms of minor or segmental trun-cal reflux may be left untreated, inwhich case treatment of only the abnor-mal tributaries can be safely and dura- bly undertaken.

EVTA is a treatment option for elim-inating reflux in a straight superficialvenous segment. The indications for ab-lation of incompetent truncal veins areidentical to those for surgical phle bec-tomy of a given incompetent vein ( Ta-

ble 3 ). These include reflux in a truncalvein of duration greater than 0.5 sec-onds that is responsible for the patientssymptoms, skin findings, or cosmeticabnormality. Treatment of competentvein segments below an incompetentvein segment, such as the below-kneeGSV when only the above-knee GSV isincompetent, is not substantiated bydata and should be discouraged toavoid unnecessary complications.EVTA can be applied to any sufficientlystraight incompetent truncal or superfi-cial vein that would allow passage of the device.Treatment of short segments of trun-cal incompetence is justified but may bemade more challenging by securing suf-ficient access of the vein to allow treat-ment. Data to evaluate the success of short segment treatment are not avail-able. Care should be taken to identifyother segments of incompetence in thetreated vein or in other veins in thesame extremity as complete obliterationof such reflux is more likely to result indurable elimination of the presentingproblem. This includes searching for re-fluxing remnants of veins previously

treated with surgery, sclerotherapy, or

EVTA.Treatment of incompetent superficialtruncal veins in the setting of deep veinreflux is safe. In many cases the reflux inthe deep veins is related to overload of the deep system by the by the regur-gitant fraction or related to a siphoneffect of the incompetent trunks ( 12).In these cases, elimination of super-ficial reflux is likely to reverse thedeep reflux ( 17).

Treatment of incompetent superficialtruncal veins in the setting of deep veinobstruction requires a careful assess-ment of the adequacy of the patent seg-ment of the deep venous system. If thedeep system is adequate and the super-ficial venous incompetence is leading toCEAP class C5 or C6 CVD, EVTA of thecausative veins is justified. Treatment of competent but enlarged superficial ve-nous segments has no proven medical benefit and should not be performed. Insome cases the enlarged vein may ulti-mately become incompetent. In otherpatients, the enlarged vein may be func-tioning as a reentry or collateral path-

way for another source of reflux or deepvein obstruction.The use of EVTA to close incompetent

perforating veins has been described. Atthis point, the indications and contraindi-cations for use as well as the success ratesand safety of this approach have only re-cently begun to be evaluated ( 18). The useof EVTA to directly close surface varicoseveins is not encouraged. These veins areusually too tortuous for current genera-tion devices to pass through. Also, theseveins are very superficial; EVTA of suchveins carries a high risk of thermal skininjury ( 19).

Table 3Medical Indications for EVTA

ClinicalQuality of life affecting symptoms of venous insufficiency (see Table 2 )Skin changes associated with chronic venous hypertension

Corona phlebectasiaLipodermatosclerosisAtrophie blanche pigmentation in the gaiter region of the lower legHealed or active ulcerationEdemaSuperficial thrombobophlebitis

AnatomicSignificant duplex USdocumented refluxStraight vein segmentIntra- or epifascial vein segment meeting other anatomic criteria



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Contraindications for EVTA

The absolute contraindications forEVTA have yet to be completely de-fined.Relative contraindications includeseveral features, some of which relate tothe clinical condition of the patient andothers to the anatomy ( Table 4 ).

In general, very few truncal veins aretoo close to the skin to prevent EVTA.Even in thin patients, these veins can bepushed away from the skin with tumes-cent anesthesia. Some believe EVTA of an extrafascial vein such as the superfi-cial accessory GSV may lead to a higher

incidence of skin pigmentation and skinpuckering, and encourage phlebectomyover EVTA of this vein. No data exist toevaluate the incidence of these observa-tions, but anecdotally these side effectsalmost always seem to be transient.

Large-diameter veins are safely andeffectively treated with EVTA assumingsufficient tumescent anesthetic solutionis infiltrated around the vein to collapseit. At this point there are no data tosuggest a correlation between diameterand anatomic success of or complica-tions after EVTA. Aneurysmal dilationof the proximal GSV or SSV at theirrespective junctions is proposed bysome as a contraindication as it is a pos-sible risk factor for thrombus extensioninto the deep venous system. This con-cern has yet to be substantiated by data.Avoidance of treating incompetent sci-atic veins with EVTA is suggested giventhis veins intimate proximity to the sci-atic nerve, and the potential for thermalmotor and sensory nerve damage.

The liver metabolizes the anestheticagents commonly used with EVTA. Pa-tients with impaired liver function may be at risk for anesthetic toxicity. In these

patients, the use of appropriate generalor regional analgesia coupled with sa-line tumescent infiltration may be a wayto allow safe EVTA. Cold saline solutionhas been demonstrated in a small seriesas an alternative tumescent agent withsimilar efficacy to dilute lidocaine ( 20).

Post-EVTA ambulation and the useof graduated compression hose is im-portant following venous treatment tominimize the risk of postproceduralDVT and to decrease superficial thrombobophlebitis in dependent tributary(ie, surface) varicose veins. This com-mon belief has not been substantiated by data. However, at this point, basedon this prevailing notion, those patientswith vascular, cutaneous, neurologic, ormusculoskeletal conditions that makeambulation or the use of compressionstocking difficult should be carefullyscreened for the need to perform EVTA.

Complications after EVTA may bepotentiated by native and iatrogenic co-agulopathies. There are few data withregard to these issues other than extrap-olation from literature regarding safetywith other venous procedures ( 21).

EVTA performed on patients taking as-pirin or nonsteroidal antiinflammatorymedications seems to be safe. No dataon the safety and efficacy of EVTA inpatients being treated with platelet ag-gregation inhibitors such as clopidogrelare available. Anecdotal reports suggestthat EVTA is safe in patients receivingthis therapy. In patients in whom it issafe to stop such therapy, the drugsprobably should be discontinued for atleast 10 days to minimize bleeding com-plications as in other venous procedures(21). The safety of EVTA used on pa-tients being treated with warfarin was

evaluated in a single small prospectivecohort study ( 22). In this review, 48 pa-tients with GSV reflux were treated withan 810-nm laser with 12W with roughly60 J/cm. Twenty-four patients were on

warfarin and a matched cohort of 24patients not on warfarin were selectedas a control group. The INR of the war-farin treated patients was 2.34.1. Therewere no significant bleeding complica-tions or excessive bruising in eithergroup following EVTA. There was atendency toward less effective ablationat one-year follow-up with DUS in theanticoagulated group but given thesample size this was not statistically sig-nificant. Of note, the energies in thefailed ablations were in the 4462 J/cmrange. Low molecular weight heparins

are routinely used at prophylactic dosesin Europe immediately following EVTAwith little risk of bleeding ( 23). How-ever, there are no data that evaluate thesafety of EVTA during heparin therapyor for its use immediately after EVTA attherapeutic doses.

EVTA in patients with hypercoagu-lable states in theory may lea d to anincreased incidence of DVT ( 23). Pa-tients with established clotting risksshould be carefully screened for theneed to perform EVTA. In those whorequire therapy for significant QOL-

related symptoms or morbidity fromCEAP class 46 chronic venous insuffi-ciency, periprocedural anticoagulationmay be considered. However, indica-tions for use, recommendations of drugchoice and therapy duration, and theefficacy of such prophylaxis have not been evaluated.

EVTA with RF ablation using thefirst generation devices uses a monoter-minal circuit and a bipolar electrode de-sign. As a result, electromagnetic inter-ference with cardiac pacemakers orimplantable defibrillators is very un-

likely (24). The original Food and DrugAdministration approval for the deviceincluded the presence of a cardiac pace-maker or implantable defibrillators as acontraindication. The Food and DrugAdministration has since removed thisrestriction, although the manufacturerrecommends appropriate precautions be used. There are no concerns of pace-maker or defibrillator interference withthe new RF catheter called Closure Fast.

First generation RF ablation use inpatients with spinal cord, dorsal col-umn, transcutaneous nerve, or vagalnerve stimulators may lead to a dys-

Table 4Relative Contraindications for EVTA

Pregnancy or nursing*Obstructed deep venous system inadequate to support venous return after EVTALiver dysfunction or local anesthetic allergy limiting local anesthetic agent useSevere uncorrectable coagulopathy, intrinsic or iatrogenicSevere hypercoagulability syndromesInability to wear compression stockings secondary to inadequate arterial circulation,

hypersensitivity to the compressive materials, or musculoskeletal or neurologiclimitations to donning the stocking itself

Inability to adequately ambulate after the procedureSciatic vein refluxNerve stimulator

* Secondary to concerns related to anesthetic drug use and related to vein or heated blood effluent which may pass through the placenta to the fetus.



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function in these devices. Consultationwith an appropriate physician about thesafety of RF ablation would be neces-sary in patients with such stimulators.There are no concerns about interfer-

ence with these devices with the use of Closure Fast.

EVTA PROCEDUREEVTA begins with a DUS evaluation

by the treating physician to confirm thelocation and extent of the venous insuf-ficiency and to direct skin marking of the vein segment or segments to betreated. The evaluation and skin mark-ing is an essential part of the EVTA pro-cedure and it is incumbent on the phy-sician performing the procedure to be as

accurate as possible to ensure an ade-quate and durable outcome. The impor-tant components of the pre-EVTA DUSinclude identifying the correct vein orvein segments to be treated (includingdetermining the length of vein or veinsthat are incompetent to ensure completetreatment), and to mark on the skin theircourse along with other important ana-tomical landmarks. These important an-atomic landmarks include deep vein junctions; hypoplastic, aplastic, aneu-rysmal, or tortuous segments; refluxingperforating veins communicating with

the vein to be treated; and large tribu-taries. Informed consent, including athorough discussion of risk, benefits,and alternatives, should be obtainedfrom the patient. The patient shouldthen be appropriately positioned on atable to allow access to all areas that areto be treated. The region to be treated isthen sterilely prepared and isolatedwith sterile barriers. The physician per-forming the procedure should wearsterile gloves and a gown, and eye pro-tection (including laser-specific attenu-ating glasses for the operator, patient,and staff in the room when appropri-ate), and all health care providers in-volved should follow universal precau-tions. A US-guided venous access intothe lowest incompetent segment of thevein is then performed. In some casesseveral US-guided venous access sitesmay be needed if the vein to be treatedis discontinuous because of prior treat-ment or phlebitis; or if the veins haveaplastic, hypoplastic, or tortuous veinsegments; or if vein spasm prevents ad-vancement of the ablation device orsheath.Cases requiring ablation of morethan one incompetent vein will also re-

quire multiple entry sites. Open venot-omy requiring a small skin incision mayalso be used to introduce an EVTA de-vice. Once venous access is achieved, aguide wire is passed intravenously and

a vascular introducer sheath (or sheaths)is inserted.There are no data to suggest im-

proved disease-free durability or clinicalimprovement for treatment of normalvein segments below documented in-competent GSV or SSV segments. How-ever, the access site or sites for EVTAshould allow treatment of the entire in-competent segment or segments if twoor more segments of the same truncalvein are involved. This may include ab-lation of intervening normal segments.Venous access(es) is then followed in

most cases by positioning the ablationdevice or devices to be used to the mostcentral location of vein to be treated. Thepositioning of the device should be care-fully monitored by duplex US to ensurethedevice is intravenous, that thedeviceallows access to the entire incompetentvenous segment, and that the workingend is not positioned in thedeep venoussystem. Accurate demonstration of thedevice and its positioning in the venoussystem require meticulous DUS tech-nique and should be performed by askilled operator. The operating physi-

cian usually performs the DUS duringEVTA. The physician may delegate theperformance of the DUS to an appropri-ately trained individual, although theresponsibility foraccurate final position-ing rests with the treating physician.

To treat reflux of the GSV beginningat the SFJ, the device is generally posi-tioned just below the junction of a com-petent epigastric vein, or other junc-tional branch to be spared, unlessotherwise indicated. Segmental treat-ment of the GSV or of GSV remnantsafter previous surgery or ablation may

also be appropriate.For SSV ablation, the tip of the deviceis positioned just beyond the take-off point of a competent thigh extension of the SSV or gastrocnemius vein, which-ever is more peripheral. If neither of these veins has an SSV connection, ab-lation generally begins at the cephaladend of the intrafascial SSV before itpasses below the muscular fascia. If thethigh extension of the SSV is also incom-petent, this segment may be treatedalong with the SSV.

Treatment of the anterior accessoryGSV, superficial saphenous vein, and

other tributary veins is also appropriateas long as they are straight enough totraverse with the EVTA device and if anappropriate amount of tumescent anes-thetic is used to protect the skin from a

thermal injury. Once the device is ap-propriately placed for ablation, the pa-tient is placed in Trendelenburg posi-tion to facilitate vein emptying andperivenous tumescent anesthesia is thendelivered. Optimal delivery of this fluidinto the saphenous space is accom-plished with real-time duplex US guid-ance. The purposes of the tumescentfluid are to externally compress andempty the vein to improve thermaltransfer to the vein wall and to separatethe vein from surroundingstructures, aswell as for its anesthetic effect.

The thermal energy is then deliveredusing protocols inherent to each device;data related to success based on the de-livered thermal dose for EVTA will bediscussed later.Aspirating on thesheathor external compression of the skin overthe tip of the ablation catheter duringthermaldelivery has been performed bysome in an attempt to further empty thevein and to contain any heated bloodfrom the deep vein beyond the junction.This may have some benefit near the junctional endof a large vein buthas not been evaluated. The use of cold tumes-

cent anesthetic agent has also been an-ecdotally suggested as helpful in induc-ing vein spasm to assist in veinemptying and energy transfer in largeveins.

Manual compression is applied tothe vein entry site to gain hemostasisafter device removal. After the proce-dure, the patient is placed in a gradu-ated compression stocking for 12weeks (an additional compressivedressing is often used for the first fewdays if phlebectomy is performed con-currently). Ambulation is initiated im-

mediately and encouraged followingthe procedure, although the value of these practices has not been establishedscientifically.

The tributary varicose veins improveor less commonly disappear in a reason-able number of patients following EVTA(25,26). However, most patients requireadjunctive procedures to eliminate thevaricose tributaries. Their eradication is believed important tocomplete the hemo-dynamic correction and maximize symp-tomatic improvement, eliminate incom-petent reservoirs that could facilitate thedevelopment of new incompetent path-



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ways, and complete the cosmetic im-provement of the treated limb. Also, as aresult, their elimination may improve thesuccess of EVTA and possibly slow theprogression of venous disease in parallel

venous trunks. Superficial thrombobo-phlebitis of large incompetent tributar-ies occurs following ablation of the un-derlying reflux without phlebectomy. Ithas been proposed that concurrent phlebectomy of such veins may reduce theincidence of this minor complication. Atthis point, data to substantiate thesethoughts are not available.

POSTPROCEDURALFOLLOW-UP CARE

Immediately following EVTA, pa-

tients are instructed to ambulate regu-larly. Vigorous exercise is generally dis-couraged for the first week after EVTAto avoid producing increased venouspressure near the central, junctional endof treated vein segments, although thereare no data to substantiate this recom-mendation. Long periods of immobilitysuch as those that occur with long airflights or car rides soon after EVTAlikely should be discouraged to mini-mize venous stasis that could increasethe risk of DVT. These practices are not based on data.

There are no convincing data to sup-port the routine use of anticoagulantswith EVTA. In Europe the use of a shortcourse of postprocedural prophylactic-dose low molecular weight heparin iscommon ( 23). The complication rate fol-lowing its use does not seem substan-tially increased, but this has not beendirectly investigated. Similarly, there areno data to clinically evaluate theof thesepractices in enhancing treatment effi-cacy, preventing complications such asdeep or superficial vein thrombosis, orpotentially increasing the rate of post-procedural bleeding complications.Patients should return for periodicclinical and duplex US evaluation toconfirm vein closure and exclude com-plications. If a physician were attempt-ing to identify thrombus extensionacross the SPJ or SFJ, duplex US in thefirst 72 hours after EVTA seems to benecessary ( 27). There is no evidence asto the best time to evaluate for DVT inthe crural, femoral, or popliteal veins.However, given the transient and be-nign clinical course of EVTA heatinduced thrombus extension in thedeepveins at the junctions as well as in the

deep veins of the calf, the necessity of evaluating all patients early for thrombus cannot be substantiated.

Follow-up duplex US examinationsshould be periodically performed to

evaluate the anatomic success of EVTA.The natural history of a successfullytreated truncal vein includes acute veinwall thickening without significant in-traluminal thrombus in the first fewweeks after treatment. This is followedover the next few months by progres-sive vein shrinkage and eventual disap-pearance on US examination ( 15,28,29).Follow-up duplex US will no longer beneeded when the treated vein is nolonger visible. Periodic follow-up du-plex US may be needed to evaluate theetiology of any new tributary varicosi-

tites to determine whether they arerelated to a recurrence of reflux in thetreated truncal vein or progression of disease in a different venous pathway.

CLINICAL EVALUATIONSOF EVTA

For RF ablation, proof-of-conceptstudies including multiple case seriesand a large sponsor-organized registryform the bulk of the published experi-ence reporting success and complica-tions with this procedure. The data in-cluded in this review were derived fromthe published experience with the firstgeneration RF devices (Closure and Clo-sure Plus). Recently, a modified versionof RF catheter, Closure Fast, has beenapproved for use in the US. The limiteddata that were available at the time thismanuscrip t was being prepared is alsoincluded ( 43) (Table 5 ).

For laser ablation, multiple proof-of-concept and case series have beenpublished reporting success and com-plications with this procedure usinglasers w ith mul tiple differ ent wave-lengths ( Table 6 ) (23,2864).

Suggested action thresholds for ana-tomic success are presented in Table 7 .In addition, clinical outcomes investi-gation of RF ablation or laser ablationinclude several small randomized con-trolled trials comparing each proce-dure wit h conventional vein stripping(Table 8 ).

SUCCESS RATESObservation Data RegardingAnatomic and Clinical Success

Anatomic success rates with RF ab-lation and laser EVTA of the GSV have

generally been reported between 85%and 100%. The follow-up for these eval-uations varies from 3 months to 4 years.There are fewer data for the SSV butthe published results are qualitatively

similar.Most EVTA recanalizations occur inthe first 6 months, and all occurred inthe first 12 months following EVTAin every reported series. This has beeninterpreted as suggesting recanalizationmay be related to insufficient thermalenergy delivery to the target vein. WithEVTA, in most cases the first 12 cm of the treated vein beyond the SFJ or SPJremains patent. Post-EVTA patency of segments less than 5 cm long beyondthe junction are the most commonform of failure. Posttreatment patency

of more than 5 cm of treated vein seg-ment is much less common ( 37). Lesssuccessful closure of the proximal veinsegment may be related to an in-creased likelihood of insufficient ther-mal transfer to this portion that is gen-erally of larger caliber, more difficultto empty, and less likely to developspasm during tumescent anestheticadministration. As a result, it is lesslikely to develop good device and veinwall apposition in this segment, whichis thought important for optimal veinwall energy deposition to achieve suc-

cessful laser or RF ablation.There is a correlation between theamount of thermal energy deliveredand the success of laser EVTA.

With laser, energy deposition has been described as that deposited percentimeter of vein length (J/cm) or asthat deposited to the vein wall using acylindrical approximation of the innersurface area of the vein (J/cm 2 ), whichcan be considered a fluence equivalent(54). Durable vein occlusion was dem-onstrated in an observational series ( 51)as more likely when the energy deliv-ered exceeded 80 J/cm, with a medianobservation of 30 weeks. Early occlusionwas also demonstrated as also morelikely in a different nonrandomizedstudy ( 54) that compared two differentenergy levels. In this study, a statisti-cally significantly higher occlusion rate by duplexUS at 3 months was seen withmean fluence levels of approximately 30 J/cm 2 (60 J/cm) compared with fluencerates of 12 J/cm 2 (24 J/cm). High ratesof vein occlusion and ultimate duplexUS disappearance was noted in a se-ries in which the thermal dose in eachsegment of the GSV was tailored to the



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diameter in that segment ( 64). Theranges of energies used included 50 J/cm for veins 4.5 mm or smaller and120 J/cm for veins larger than 10 mmin diameter. No increase in complica-tions was seen with any of the higher-energy strategies. At this point, a pro-spective randomized evaluation of therelationship of the amount of laser en-ergy deposition at a fixed wavelengthand its effects on the rate of anatomi-cally successful vein obliteration andcomplication rates has not been per-formed.

A similar correlation between theenergy delivered and succe ss has beendefined for RF ablation ( 36). Whenpullback rates were decreased from 3cm/min to 2 cm/min, a clear correla-tion with anatomic success was dem-onstrated. Most of the clinical data col-lected for RF ablation use a targettreatment temperature of 85C and apullback rate of 3 cm/min. Equivalentresults with observational studies at 6months have been demonstrated with

the use a target temperature of 90C incombination w ith a faster catheterpullback rate ( 41). This has allowedenergy delivery times to be shortened by 50% without an increase in compli-cations.

Patients with a high body mass indexhave been shown to have a higher rateof failure with laser and RF ablation(36,56). The rationale for this observa-tion is unclear, although it is known thatobese patients have higher central ve-nous pressures and a higher frequencyof chronic venous disease.

Successfully treated veins have beendemonstrated to occlude and shrinkwith time ( 28,29,64). Successfullytreated veins eventually shrink and become difficult to find. The averagemean duration for a treated GSV toshrink to a fibrous cord of less than 2.5mm diameter is 6 months ( 29). In an-other study, at 1 year following laserablation of the GSV, the treated seg-ments were not visualized in 95%, oc-cluded but visible in 2%, and patent in

2% (62). In another study ( 65), at2-year follow-up, 41% of occludedveins were undetectable and 51% hadshrunk to a mean diameter of 2.9 mm.

Late clinical recurrence is extremelyunlikely in an occluded vein that hasshrunken to a noncompressible cord(28,37,64). Based on this and surgicaldata that demonstrate that the patho-logic events that lead to recurre nce usu-ally take place within 2 years ( 66), laterclinical recurrences are more likely re-lated to development of incompetencein untreated veins or vein segments (ie,progression of disease in other veins).To a great extent, late clinical successafter EVTA is predicated by the naturalhistory of the venous insufficiency in agiven patient, the ability of the treat-ing physician to identify and eliminateall incompetent pathways (often de-scribed as tactical and technical suc-cess), as well as the success of the adjunctive procedures used to eradicateany coexistent incompetent tributaryveins after EVTA.

Table 5Published Observational Series of RF Ablation for Truncal Reflux ( 28,3044)

Study, Year Limbs VeinAnatomic

Success (%)Duplex US Follow-up

(mo)Major

Complications (%)

Goldman et al, 2000 (30) 12 GSV 100 6 0Goldman et al, 20 02 (31) 41 GSV 68 624 0Weiss et al, 2002 (32) 98 GSV 96 6 1

21 GSV 90 24 NRMerchant et al, 2002 ( 33) 223 GSV 87 6

232 GSV 84 12 NR142 GSV 85 24 NR

Wagner et al, 2004 (34) 28 GSV 95 3 3Pichot et al, 2004 (28) 63 GSV 90 25 NRHingorani et al, 2004 (35) 66 GSV 16 (DVT)Merchant et al, 2005 ( 36) 1161/61 GSV/SSV

473 87 12 NR263 88 24 NR133 84 36 NR119 85 48 NR

117 87 60 NRNicolini et al, 2005 ( 37) 68 GSV 88 36 0Merchant et al, 20 05 (38) 98 GSV 89 48 NRMozes et al, 2005 (39) 56 GSV NR NR 8Puggioni et al, 20 05 (40) 53 GSV/SSV 91 1 NRDunn et al, 2006 ( 41) 85 GSV 90 6 NRRavi et al, 2006 (42) 159 GSV 97 36 NRAlmeida et al, 2006 ( 43) 95/11 GSV/SSV 95 16 0Proebstle et al, 2008 ( 44)* 252 GSV 99 6 0

Note.Clinical evaluations of laser ablation have been performed using laser energy of several wavelengths (810, 940, 980, 1,329,and 1,320 nm) that are produced by several manufacturers. The published experience with this technique is composed of proof-of-concept studies including multiple cases series ( Table 6 ). NR not reported.* Study used the ClosureFast device. Mean measurement. The data for GSV and SSV were reported together in this review.



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Two comparisons of wavelength of delivered laser energy have been per-formed. One study compared 940 nmand 1,320 nm in a retrospective analysis

and another compared 810 nm and 980nm in a randomized prospective study(55,57). Both studies demonstratedequivalent occlusion rates for the differ-ent wavelengths when used at similarrates of energy deposition. No differ-ences in the complication rates wereseen in patients treated with differentwavelengths, but differences in the side

effects of bruising and postproceduraldiscomfort were described. No random-ized analysis evaluating outcomes andcomplications using differences in rateof energy delivery (Watts), linear energydeposition or fluence, controlling forother variables, has been performed.

EVTA success has been demon-strated in retrospective data review to be independent of vein diameter inmany studies. However, a prospectiveconfirmation of this conclusion has not been performed.

No prospective comparison of RF ab-lation and laser anatomic or clinical

rates has been performed. Several retro-spective analyses of observational datahave demonstrated qualitatively similarocclusion and complication rates(42,43,67). Anecdotally, bruising anddiscomfort have been thought to be lesswith continuous-mode laser depositionthan with pulsed-mode deposition. Thistoo has not been substantiated by pub-

lished data.Several studies have documentedsignificant and durable improvementsin validated assessments of QOL follow-ing EVTA. Two studies demonstratedsignificant improvements in the Aber-deen Varicose Veins Questionnaire(AVVQ), Short Form36 (SF-36), andVCSS as long as 6 months followinglaser ablation (which were at least asgood or better than the improvementsseen following high ligation and strip-ping (HL/S) ( 68,69). VCSS scores wereshown to decrease significantly in thosepatients treated with either laser or RF

Table 6Published Observational Series of Laser Ablation for Truncal Reflux ( 23,29,40,42,43,4564 )

Study, Year Limbs VeinAnatomic

Success (%)Duplex US Follow-up

(mo)Major Complication

Rate (%)

Navarro et al, 2001 ( 45) 40 GSV 100 4.2 0Min et al, 2001 (46) 90 GSV 97 9 0Proebstle et al, 2003 ( 23) 104 GSV 90 12 NROh et al, 2003 (47) 15 GSV 100 3 NRMin et al, 2003 (48) 499 GSV 98 17 0Proebstle et al, 2003 ( 49) 39 SSV 100 6 NRPerkowski et al, 2004 ( 50) 154 GSV 97 618 NR

37 SSV 96 618 NRSadick et al, 2004 (51) 31 GSV 97 24 0Timperman 2004 et a l, (52) 111 GSV NR 7 NRProebstle et al, 2004 ( 53) 106 GSV 90 3 NRGoldman et al, 2004 (54) 24 GSV 100 6 (9) NRProebstle et al, 2005 ( 55) 223 GSV 92 3 NRTimperman et al, 200 5 (56) 100 GSV 91 9 1Puggioni et al, 2005 ( 40) 77 GSV/SSV 94 1 NR

Kabnick et al, 2006 ( 57) 60 GSV 92 12 NRAlmeida et al, 2006 ( 43) 483/104 GSV 98 16 0.3Yang et al, 2006 (29) 71 GSV 94 13 NRKim et al, 2006 (58) 60 GSV 95 3 NRKavuturu et al, 200 6 (59) 66 GSV? 97 9 NRMeyers et al, 2006 ( 60) 334 GSV * 36 NR

70 SSVSadick et al, 2007 (61) 94 GSV 96 48 NRTheivacumar et al, 2007 (62) 81 GSV 98 12 NRGibson et al, 2007 ( 63) 210 SSV 100 1.5 NRRavi et al, 2006 (42) 990 GSV 97 3042 NR

101 SSV 90 3042 NRDesmyttere et al, (2007) ( 64) 511 GSV 97 48 (34 limbs at 4 y) NR

Note.NR not reported.* Survival determined by Kaplan-Meier analysis. EVL SFJ thrombus extension. Mean measurement.

Table 7Anatomic Success at 1 Year*

TreatmentType

ReportedRange

(%)

ActionThreshold

(%)

RF ablationGSV 68100 80SSV None 80

Laser ablationGSV 92100 85SSV 92 85

Other veins None 90

* Defined as duplex US disappearanceof the entire treated vein segment. Remnant after surgery or accessoryGSV.



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ablation and powered phlebectomy(67). Another study (57) demonstratedsignificant improvements in the VCSS 4months after treatment with laser alone.Another study ( 70) demonstrated signif-icant Aberdeen Varicose Veins Scoreimprovement at 1 year following laser

ablation, regardless of the number of

patent tributary branches found at theSFJ.

Evaluation of the effectiveness of EVTA in CEAP class 46 patients wasperformed in a retrospective review of patients 6 weeks after they were treatedwith RF ablation and laser ( 67). An 85%

rate of vein occlusion was noted overall,

with significant improvements in ve-nous clinical severity scores and airplethysmography findings. The correc-tion in venous filling index on air pleth-ysmography has been correlated withlong-term symptomatic relief in surgicalseries ( 71). Marston et al ( 67) docu-

mented improvement in air plethys-

Table 8Comparison of EVTA and Surgery for GSV Reflux ( 64,68,69,7278)

Study, Year Type Limbs Method Follow-up Results for RF Ablation Versus Surgery

Rautio et al, 2002 (73) RCT 1513

RFHL/S

50 d 1. VAS pain score and med use less at 14 d2. Less sick leave3. RAND-36 pain score lower at 1 week but

equal later4. Duplex US closure rate, 100%5. VSS and complications no different

Lurie et al, 2003 (64)* RCT 4436

RFHL/S

4 months 1. Time to normal activity, 1 d vs 4 d2. Return to work, 5 d vs 12 d3. CIVIQ2 better for RF at 1 week and 4

months4. VCSS better for RF at 1 and 3 weeks, equal

at 4 months5. Duplex US closure rate, 91%6. Equal complications

Lurie et al, 2005 (74)* RCT 4436

RFHL/S

2 y 1. Equal rates of new vessels (2% vs. 11%)2. Equal recurrent varicose veins (14% vs. 21%)

3. CEAP improvement equal4. VCSS better with RF at 72 h and 1 weeks,equal at 4 months and 2 y

5. QOL better with RF at 72 h, 1 weeks, and 1and 2 y, equal at 3 weeks and 4 months

6. Duplex US: no reflux segments of GSV in88% vs 92%

Perala et al, 2005 (75)* RCT 4436

RFHL/S

2 y 1. Equal VCSS, VDS, VSDS scoreimprovements

2. Equal recurrent varicose veins andneovascularity

de Medeiros et al, 2005(72)

Contralateral legs 2020

HL/SHL/laser

8 weeks 1. More swelling/bruising with surgery2. At 60 d, equivalent outcomes by QOL

evaluation, APG3. 70% favored laser, 10% felt treatments were

equivalentStotter et al, 2005 ( 76) RCT 20

2020

RFHL/SHL/cryo

1 y 1. Duplex US: 90/100/902. VAS pain less for RF ablation3. CIVIQ activity impairment better with RF to

1 y4. RTW/RTA better for RF

Mekako et al, 2006 (68) Case comparison 6270

HL/SLaser

12 weeks 1. SF-36 better for laser at 1 and 6 weeks, equalat 12 weeks

2. AVVQ better for laser at 1, 6, and 12 weeks3. VCSS improvements at 1 ,6, and 12 weeks

Vulsteke et al, 2006 ( 77) RCT 8480

HL/SLaser

NR 1. QOL, medication use, and sick days betterfor EVLT

Hinchliffe et al, 2006 ( 78) RCT HL/S RF

Rasmussen et al, 2007 ( 69) RCT 6867

LaserHL/S

6 months 1. Equivalent technical success, VAS, VSS,AVVQ, SF-36, duplex US

Note.APG air plethysmography; AVVQ Aberdeen Varicose Veins Questionnaire; HL high ligation; HL/S highligation and stripping; NR not reported; QOL quality of life; RCT randomized controlled trial.* Same patients.



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mography following EVTA at 6 weeksand de Medeiros and Luccas ( 72) at 8weeks following ablation. Ulcer healinghas been induced after EVLT. One re-port documented an 84% success with

ulcer healing with a combination of ei-ther RF ablation or laser and microphlebectomy with 77% of these healing lessthan 2 weeks after the procedure ( 42).

Randomized Clinical Comparisonsof EVTA and Surgery

As with any new treatment method-ology, its acceptance as a standard of practice goes thought an evolution fromproof-of-concept studies to clinical com-parisons to other existing standards of practice. Randomized and controlleddata to compare the short-term and in-termediate outcomes in patients withvenous disease from truncal refluxtreated with EVTA or HL/S are avail-able at this time ( Table 8 ).

Several small comparisons of EVTAusing RF ablation and HL/S for theGSV have been performed ( 65,73,74,78).In the EVOLVEeS sponsor-supportedprospective randomized trial ( 65),postoperative pain was less severe, ab-sence from work and return to normalactivities was shorter, and physicalfunction was restored faster after RFablation at 4-month follow-up. At2-year follow-up, recurrent varicoseveins were found in 21% of patientstreated with HL/S and 14% of patientstreated with RF ablation, but this dif-ference did not reach significance be-cause of the small treatment popula-tions ( 74). However, the likelihood of recurrence was 4.5 times higher inlimbs with open GSV segments com-pared with those with successfullyclosed truncal veins, but this also didnot achieve significance. In addition,

at 2 years after treatment, the patientstreated with RF ablation had main-tained better QOL sc ore s comparedwith the HL/S group ( 74).

Another small prospective random-ized trial by Rautio et al ( 73) demon-strated less pain and more rapid recov-ery following GSV RF ablationcompared with HL/S. Finally, clinicaloutcome and patient satisfaction werealso better in the short term, but by 6months these differences were no longersignificant. The conclusions of thesesmall randomized studies of surgeryand RF ablation suggest equivalent out-

comes with shorter recovery periods forEVTA.

Several small comparison studieshave evaluated the outcomes of laserablation and surgery. In the first to be

published ( 72), 20 patients with bilateralGSV reflux were treated with conven-tional HL/S on one leg and HL andlaser in the other and then followed for3 months. The patients were not in-formed which leg received which ther-apy, the choice of which technique wasused was randomized, and all patientswere treated with spinal or epidural an-esthesia. No tumescent anesthetic wasused. Early pain was similar for bothprocedures, although bruising andswelling was worse with surgery. Allpatients thought the aesthetic improve-

ment was much better in both limbs but70% thought the laser-treated limb ben-efited more, 20% the surgical limb, and10% thought they were equal. Air pleth-ysmography improvements wereequivalent in both groups.

A nonrandomized consecutive treat-ment comparison of conventional HL/Swith general anesthesia and laser abla-tion of the GSV using tumescent anes-thesia has been performed ( 68). Thisstudys goal was to compare the sever-ity of venous disease and QOL changesat 1 and 12 weeks following laser treat-

ment using the SF-36, Aberdeen Vari-cose Veins Questionnaire, and VCSS in-struments. The authors demonstratedthat, with the SF-36 at1 and 6 weeks, thelaser treatment recipients did not havethe decrease in QOL seen in the surgicalgroup at the same time. By 12 weeks, both groups had similar improvementsin QOL and in an objective assessmentof the severity of their venous disease.With the Aberdeen Varicose VeinsQuestionnaire, at 1 week, EVLT wassimilar in the decrease in QOL com-pared with surgery. However, at 6 and

12 weeks, QOL with laser treatment wassignificantly better than that with sur-gery. The VCSS improvement was sig-nificant compared with the pretreat-ment assessment and similar for bothgroups of patients.

A randomized comparison of 118limbs treated with laser and microphlebectomy and 124 with conventionalHL/S and microphlebectomycomparedthe QOL of the po stprocedural period of both procedures ( 77). The study demon-strated significantly less postoperativemorbidity for the laser procedure usingthe CIVIQ instrument of Launois. In ad-

dition, patient satisfaction, analgesiause, and number of days before returnto work were significantly better for thelaser-treated group.

A randomized trial of 68 limbs

treated with HL/S and 62 with laserwas performed with both groups beingtreated with only tumescent anesthesia(69). The preliminary report of this on-goingstudy evaluated thepatientsup to6 months after their procedure using avariety of validated instruments includ-ing a visual analog scale of pain, VCSS,AVVSS and SF-36. Initial technical suc-cesses were equivalent. In this trial theearly bruising and pain favored laser but by 3 months both procedures dem-onstrated significant improvements inall indices compared with pretreatment

baselines; however, no differences wereseen between HL/S and laser. One in-fection requiring antibiotics occurred inthe surgical group. One patient in thelaser group developed proximal exten-sion of thrombus into the femoral veinthat spontaneously resolved withouttreatment.

As previously mentioned, given thatthe case series have demonstrated avery high rate of treated vein disappear-ance following EVTA, it is likely thatclinical recurrence will infrequently berelated to failure of the EVTA. Recur-

rence in these cases will likely resultfrom progression of the venous diseasein other vein segments. However, ran-domized and controlled data to com-pare late clinical recurrence in patientstreated with EVTA or HL/S to substan-tiate this assertion are not available atthis time.

COMPLICATIONSAdverse events following EVTA oc-

cur, but almost all are minor. Ecchymo-sis over the treated segment frequentlyoccurs and normally can last for 14days. Approximately 1 week afterEVTA, the treated vein may develop afeeling of tightness similar to that after astrained muscle. This transient discom-fort, likely related to inflammation inthe treated vein segment, is self-limitedand may be ameliorated with the use of nonsteroidal antiinflammatory drugsand graduated compression stockings.Both of these side effects are more com-monly described after EVTA using ex-isting laser protocols than for RF abla-tion, although direct objective blindedcomparison has not been performed.



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Superficial phlebitis is another uncom-mon side effect after EVTA, being re-ported after approximately 5% of proce-dures ( 48). There are no publishedreports of superficial phlebitis afterEVTA progressing to DVT, and it has been managed in most series with non-steroidal antiinflammatory medication,graduated compression hose, and ambulation. Anecdotally, superficial phlebitis seems to be more common in larg-er-diameter dependent varicose veins orin varicose veins that have their inflow

and outflow ablated by EVTA. Concur-rent phlebectomy of these veins at thetime of EVTA has been recommendedto decrease the risk of this side effect, but at this point there are no data tosubstantiate this claim.

More significant AEs reported fol-lowing EVTA include neurologic inju-ries, skin burns, and DVT (Table 9 ). Theoverall rate of these complications has been shown to be higher in low-volumecenters compared with high-volumecenters ( 36). The nerves at highest riskinclude the saphenous nerve, adjacentto the GSV below the midcalf perforat-

ing vein, and the sural nerve adjacent tothe SSV in the mid- and lower calf. Bothof these nerves have only sensory com-ponents. The most common manifesta-tion of a nerve injury is a paresthesia or

dysesthesia,mostof which are transient.Thenerve injuries can occur with sheathand catheter introduction, during thedelivery of tumescent anesthesia, or bythermal injury related to heating of theperivenous tissues.

Tumescent anesthesia has been dem-onstrated to reduce perivenous temper-atures with l aser (79) and with RF abla-tion ( 41,80). The delivery of theperivenous fluid is believed to be re-sponsible for the low rate of cutaneousand neurologic thermal injuries seen inthe series of patients treated with it. An

extremely high rate of nerve injuries andskin burns were reported in the article by Chang and Chua ( 20). This clearlywas related to the use of extraordinarilyhigh rates of energy delivery and directtreatment of varicose tributaries withoutthe use of tumescent anesthetic treat-ment. Neurologic injuries are seen aftertruncal vein removal and are related toinjury to nerves adjacent to the treatedvein (81). Paresthesias caused by EVTAare mostly temporary. Excluding outli-ers, the rates of permanent paresthesiastypically reported for laser EVTA of

above-knee GSV are 0%15%. Only asmall number of series look at the SSV.The reported rates of temporary pares-thesia following SSV EVTA are approx-imately 0%10%.

The higher rates typically reportedfor RFablationmay be related to the factthat tumescent anesthesia was not com-monly used with this procedure whensome of the data were collected. The1-week paresthesia rate following RFablation was shown to decrease from15% to 9% after the introduction of tu-mescent anesthesia ( 36). Patients treatedwith laser EVTA performed without tu-mescent anesthetic infiltrations exhib-ited a high rate of such injuries ( 20).

There is evidence suggesting ahigher rate of nerve injuries reportedwhen treating below-knee GSV with tothe above -knee segment ( 32,33,82) andthe SSV (36). Treatment of below-kneeGSV or the lowerpartoftheSSV may benecessary in many patients to treat toeliminate symptoms or skin diseasecaused by reflux to the ankle. A retro-spective review ( 82) demonstrated that below-knee laser ablation can be per-formed with an 8% rate of mild but per-

manent paresthesias with adequateamounts of tumescent anesthesia. It isalso suggested by these data that spar-ing the treatment of the distal 510 cmmay accomplish clinical benefit and po-

tentially avoid saphenous nerve injuryrisk in patients with reflux to the medialmalleolus.

Skin burns following EVTA have been reported following RF and laserablation. Skin burns are fortunately rel-atively rare and seem be avoidable withadequate tumescent anesthesia. Therates of skin burn in one series ( 38) us-ing RF ablation were 1.7% before and0.5% after the initiation of the use of tumescent technique during RF ablationEVTA. The earl y experience hadrates ashigh as 4% (33) that decreased to almost

zero as the use of tumescent anesthesia became a standard of practice.DVT following EVTA is unusual.

DVT can occur as an extension of thrombus from the treated truncal veinacross the junctional connection into thedeep vein or in the calf or femoral pop-liteal veins. The reported rates of junc-tional thrombosis following GSV EVTAvaries widely. This variability may re-late to the time of the follow-up exami-nation and the methods used. Most se-ries using early duplex US ( 72 h afterEVTA) document a proximal extension

for the GSV of approximately 1% ( Ta-bles 5 and 6 ). Those performing the du-plex US later identify a lower rate. It ispossible the rates are different for differ-ent operators or that the proximal exten-sion of thrombus is self limited withouta clinical event. Pooling data from sev-eral sources suggests the incidences areapproximately 0.3% after lase r ablationand 0.4% after RF ablation ( 83). Thistype of DVT is almost universallyasymptomatic. The significance of thistype of thrombus extension into thefemoral vein seems to be different that

that with native GSV thrombosis withextension or compared with typicalfemoral vein thrombosis ( 84).

The incidence of junctional extensionof thrombus after SSV ablation has beendescribed to be low ( 6%) (42,63). Inone study (63), the rate of popliteal ex-tension of SSV thrombus at 24 daysafter EVTA was thought to be related tothe anatomy of the SPJ. The incidenceswere zero when no SPJ existed and 3%when a thigh extension existed, but 11%when no junctional vein could be iden-tified.

The incidence of DVT in other pe-

Table 9Complications of EVTA*

Complication

ReportedRange

(%)

SuggestedThreshold

(%)

DVTRF ablation

GSV 016 5SSV NR 5


Paresthesia(temporary andpermanent)RF ablation

GSV 015 10SSV NR 10

Laser ablation

GSV 012 10SSV 010 10Skin burn

RF ablationGSV 07 1SSV NR 1


Note.NR not reported separately.* Complications other than thoseconsidered minor by SIR classification.



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ripheral deep veins after EVTA has not been well evaluated, as the results of routine scanning of the entire extremityare rarely described. However, the inci-dence of symptomatic DVT of the calf,

popliteal, and femoral veins is very low.Neovascularity at the SFJ afterEVTA, as a form of recurrence of vari-cose veins, seems to be rare at 13-yearfollow-up ( 28,48,70). Neovasculariza-tion was seen in only two of the 1,222limbs followed for up to 5 years in anindustry-sponsored registry of patientstreated with RF ablation ( 36). Longerfollow-up may be necessary to feel con-fident with this observation; however,neovascularization following HL/Sneovascularization i s common and of-ten an early event ( 8,85). A study was

performed with the principal endpointcomparing the number of vessels seen bef ore and 1 year after laser ablation(70). At 1 year there was a 98% successrate in vein occlusion, with 97% of theoccluded veins becoming invisible bythis point. Neovascularity was foundin only one patient. In all the others,there was either flush occlusion tothe SFJ (40%) or one or more compe-tent tributa rie s in continuity with theSFJ (59%) (70).

Anecdotal reports of laser fiber frac-ture or retained venous access sheaths

have been made to the device manufac-turers, and a case report exists describ-ing a retai ned vascular sheath after laserablation ( 86). Respecting the fragileglass laser fibers and being gentle withits handling should help minimize laserfiber fractures. The possibility of a laserfiber fracture should be considered withthe removal of the device in each case.Care to deliver thermal energy only be-yond the introducer sheath and awayfrom any other parallel placed sheath isessential to avoid severing segments of these catheters. No specific manage-ment recommendations of retained in-travenous laser fiber or sheath frag-ments can be made based on the data.

A case report of an arteriovenous fis-tula between a small popli teal artery branch and the SSV exists ( 87). Anec-dotal references have been made of ad-ditional arteriovenous fistulas betweenthe proximal GSV and the contiguoussuperficial external pudendal artery. Al-though thought to be related to a heat-induced injury caused by the thermaldevice, an arteriovenous fistula could becaused by a needle injury during tumes-cent anesthetic administration. Ways to

minimize the risk of these arteriovenousfistulas include careful advancement of the intravascular devices, atraumatic de-livery of the tumescent anesthetic fluid,the use of copious amounts of tumes-

cent fluid, and avoidance of treating thesubfascial portion of the SSV wherepopliteal artery branches exist.

CONCLUSIONSEVTA is one of several potential

treatment options for patients with SVI.It can safely, effectively, and durablyeliminate reflux in truncal veins usingonly local anesthesia. Successful out-comes require a thorough understand-ing of the disease process and the anat-omy of the superficial venous system. Athorough examination with Duplex USis essential to make the correct diagno-sis. Treatment planning, technical de-tails, and postprocedural care unique tothis procedure are important to under-stand.

Acknowledgments: Neil M. Khilnani, MD,authored the first draft of this document andserved as topic leader during the subsequentrevisions of the draft. Clement J. Grassi, MD,is chair of the SIR Standards of Practice Com-mittee. John F. Cardella, MD, is Councilor of the SIRStandards Division. Allother authorsare listed alphabetically. Other members of the Standards of Practice Committee and SIRwho participated in the development of thisclinical practiceguideline areas follows: San- joy Kundu, MD, John Fritz Angle, MD,Ganesh Annamalai, MD, Stephen Balter,PhD, Daniel B. Brown, MD, Danny Chan,MD, Timothy W.I. Clark, MD, MSc, BairbreL. Connolly, MD, Brian D. Davison, MD,Peter Drescher, MD, Debra Ann Gervais,MD, S. Nahum Goldberg, MD, Manraj K.S.Heran, MD, Maxim Itkin, MD, Sanjeeva P.Kalva, MD, Patrick C. Malloy, MD, Tim Mc-Sorley, BS, RN, CRN, Philip M. Meyers, MD,Charles A. Owens, MD, Dheeraj K. Rajan,MD, Anne C. Roberts, MD, Steven C. Rose,MD, Tarun Sabharwal, MD, Nasir H. Sid-diqu, MD, LeAnn Stokes, MD, Patricia E.Thorpe, MD, Richard Towbin, MD,Aradhana Venkatesan, MD, Louis K. Wag-ner, PhD, Michael J. Wallace, MD, JoanWojak,MD,DarrylA. Zuckerman, MD, Cur-tis W. Bakal, MD, Curtis A. Lewis, MD,MBA, JD, Kenneth S. Rholl, MD, DavidSacks, MD, Thierry de Baere, MD, FabricioFanelli, MD, Alexis Kelekis, MD, and Man-uel Maynar, MD

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Documents

Multi-society Consensus Quality Improvement Guidelines for the Treatment of Lower- extremity Superficial Venous Insufficiency with Endovenous Thermal Ablation from the Society of Interventional