Multi-society Consensus Quality Improvement Guidelines for ... · remove them. Endovenous thermal ablation (EVTA) of the saphenous veins has been used by physicians since the late

Multi-society Consensus Quality Improvement
Guidelines 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. D’Agostino, 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; 21:14–31

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 Form–36, 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,

From Cornell Vascular (N.M.K.) and the Depart-ment of Radiology (R.J.M.), New York PresbyterianHospital–Weill Cornell Medical Center, New York,New York; Department of Radiology (C.J.G.), LaheyClinic Medical Center, Burlington; Department ofRadiology (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
14

and subsequent major disability. Ve-nous hypertension caused by incom-petent valves in the superficial veins isby 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

Medical Center, Bethesda, Maryland; Department ofInterventional 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 ofRadiology (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,
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-

3975 Fair Ridge Dr., Suite 400 N., Fairfax, VA 22033;E-mail: [email protected]

None of the authors have identified a conflict ofinterest.

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

mailto:[email protected]

Khilnani et al • 15Volume 21 Number 1

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 oftheir 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.

METHODOLOGY

SIR creates its Standards of Practicedocuments with use of the followingprocess. Standards documents of rele-vance and timeliness are conceptualizedby 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 project’s 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 mem-bers with use of a modified Delphi con-sensus method. For the purpose of thesedocuments, consensus is defined as 80%participant agreement on a value or pa-rameter.

The draft document is critically re-viewed by the Standards of Practice Com-mittee members in either a telephone con-ference call or face-to-face meeting. Therevised draft is then sent to the SIR mem-bership for further input/criticism during
a 30-day comment period. These com-
ments are discussed by the Standards ofPractice Committee members and appro-priate revisions are made to create the fin-ished Standards document. Before itspublication, the document is endorsed bythe SIR Executive Council.

The current guidelines are written tobe used in quality improvement pro-grams to assess thermal ablation oflower-extremity superficial venous insuf-ficiency (SVI). The most important ele-ments of care are (i) pretreatment evalua-tion and patient 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 physiciansshould strive to achieve perfect outcomes,in practice all physicians will fall short ofideal outcomes to a variable extent. 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 abenchmark that can take into accountboth 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 in
the literature include clinical outcomes
and proof-of-concept–type publications.In evaluating the existing publications,several major limitations are evident:(i) extreme variation in definitions ofshort-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 truncal veinsin 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 am-bulatory basis with local anesthetic andtypically requires no sedation. The pa-tients are fully ambulatory followingtreatment and the recovery time is short.

These guidelines are intended for usein 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 ofoutcome measures is also desirable, andthese include technical success, complica-tions, efficacy, and recurrence rates, whichare assigned threshold levels based on the
currently available data.

we

16 • Guidelines for Ablation for Lower-extremity Venous Insufficiency January 2010 JVIR

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 ofthe superficial venous system, the GSVbegins on the dorsum of the foot and as-cends along the medial aspect of 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 word“great” 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 word“small” replaces “lesser” or “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 acces-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 the saphenous veins andtheir intrafascial straight primary tribu-taries (Fig).

Disorders

Venous reflux.—Veins contain valves
that direct blood flow in one direction.
Usually, this is from the foot toward theheart and from the 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 greaterthan 0.5–1.0 seconds following release ofcompression on the muscular mass be-low the vein itself.

Venous obstruction.—Obstruction ofvenous 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 thatresults from chronic venous hyperten-sion (3). The overwhelming majority ofpatients 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% ofpatients and nonsaphenous superficialreflux is identified in 10%–15% of pa-tients (5,6). Venous obstruction, deepvein reflux, muscular pump failure, and

Figure. Superficial truncal veins of the lo

congenital 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 ofobstruction 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, andpathophysiology (CEAP) classification.—“CEAP” is an acronym for a descriptive

r extremity.

classification system that summarizes


the disease 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 physical observations ofdisease severity (Table 1).

The venous severity score (VSS) is anadditional means of grading the spectrumof disease severity (10). The VSS allowsmore detailed description of the severityof attributes of CVD compared with theCEAP system. The VSS is the sum ofscores 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 reporting clinicalsuccess 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 a

Table 1CEAP Classification

Class Description

C0 No visible or palpable signs ofvenous 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 ulcerC6 Active venous ulcer

procedure 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 3–4-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 theveins 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 term“tumescent.” Popularized by plasticsurgeons, 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 EVTA is defined as per-manent occlusion of the entire treatedvein segment. Duplex US is essential todocument the anatomic success ofEVTA. 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 isdefined 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 use
anatomic success of EVTA.


Complications

Paresthesia and dysesthesia.—Pares-thesia and dysesthesia describe the lossor aberration, respectively, of normalsensory perception. Injury to the saphe-nous or sural nerves adjacent to the GSVor SSV, respectively, can lead to thesesensory disturbances.

DVT.—DVT is thrombosis in theveins deep to the muscular fascia.

Superficial thrombobophlebitis.—Super-ficial thrombobophlebitis refers tothrombosis in veins superficial to themuscular fascia. The veins involvedcould include the saphenous veins andtheir named tributaries, as well as sub-cutaneous collecting veins.

Arteriovenous fistula.—An abnormalconnection directly between an arteryand a vein is an arteriovenous fistula.Such a connection may be created iatro-genically by a penetrating or thermalinjury during EVTA.

Toxicity related to tumescent anesthe-sia.—Toxicity can develop from the useof large doses of lidocaine used forperivenous anesthesia.

Skin burn.—Thermal injury to theskin can occur from extension of theheat delivered into the vein.

PHYSICIAN QUALIFICATIONSAll patients with CVD should un-

dergo a complete clinical and duplex USevaluation before being considered acandidate for EVTA. This evaluationand subsequent treatment should beperformed by a physician who is appro-priately trained in the care of patientswith venous disorders. The body ofknowledge required by such a physi-cian includes a thorough understandingof the anatomy, physiology, pathophys-iology, and clinical course pertaining tothese conditions. The physician shouldbe experienced in the performance andinterpretation of duplex US of the ve-nous system as well as conservative,medical, and procedural approaches fortreating venous disorders. The requisiteknowledge, clinical, and procedural ex-perience required to care for patientswith venous disorders can be acquiredin a number of ways. Many physicianswill acquire the necessary knowledgeand skills through continuing medicaleducation and/or mentored clinical ex-periences (11) after their postgraduatemedical training. The knowledge andskills can also be obtained through post-
graduate medical training in an Accred-
itation Council for Graduate MedicalEducation–recognized (or approved)postgraduate training program.

PRETREATMENTASSESSMENT

Evaluation of the patient before treat-ment in an outpatient setting providesthe physician an opportunity to reviewthe patient’s medical history, perform aphysical examination, and evaluate thepatient’s venous system with DuplexUS. Only after such an examination canthe patient and physician engage in aconversation regarding treatment op-tions. Patients with duplex US–docu-mented truncal incompetence have theoption of selecting conservative treat-ment of their symptoms with graduatedcompression stockings, EVTA, surgicalremoval of the vein, or sclerotherapy.

A complete medical history of thepresenting venous problem, previoustherapy and response, history of throm-bosis, comorbidities, medications, aller-gies, and any pertinent family historyshould be obtained from the patient.Chronic venous insufficiency causessymptoms in many patients that can im-pact their quality of life (QOL). Thesesymptoms are summarized in Table 2.

All these symptoms are worse withprolonged standing or sitting, improvewith ambulation, and are most notice-able at the end of the day. In longstand-ing cases, patients may develop skindamage in the form of eczema, coronaphlebectasia, pigmentation, and lipo-dermatosclerosis, and eventually mayform skin ulceration. A family historysearching for a risk of a hypercoagulablestate should also be obtained. Labora-tory evaluation is recommended for pa-tients with a history strongly suggestiveof a hypercoagulable state.

A complete physical examination ofthe patient below the waist should beperformed. This should generally beperformed in the standing position andshould include all aspects of the lowerextremities as well as the lower abdo-men and pelvis in patients in whom iliacvein occlusion is suggested.

Visible vein abnormalities includingtelangiectasias, venulectasias, and vari-cose veins should be documented.Edema of the extremities should beidentified. Careful attention should bedirected at the skin near the ankle, asthis region is most vulnerable to the ef-
fects of long-term venous hypertension.
Manifestations of CVD such as skin hy-perpigmentation, corona phlebectasia,eczema, lipodermatosclerosis, and ul-ceration should be noted. It is suggestedthat a standardized means of clinicallyassessing the severity of the effects ofthe chronic venous hypertension, suchas the CEAP scale, be used to documentone’s findings. In addition, it is sug-gested that a written documentation ofthe history and clinical and duplex USexamination findings be produced foreach patient, including a discussion ofthe impression and clinical recommen-dations. Photographs of the visible find-ings are also helpful to document theseverity and extent of the disease.

Duplex US Evaluation

Duplex US is essential in all patientswith CEAP clinical class C2 or higherCVD to identify reflux and patency andestablish the pattern of disease to plantreatment. The technique of duplex USfor CVD is different than for the evalu-ation of lower-extremity thrombosis.The goals, objectives, and technique ofthis examination have been reviewed ina consensus statement by the Union In-ternationale de Phlebologie and theAmerican College of Phlebology, as wellas in several recent publications (13–15).During this examination it is importantto evaluate the anatomy and the physi-ology of both the superficial and deepvenous systems. A thorough knowledgeof the anatomy of the superficial venoussystem and its common variants is nec-essary. Accurate use of the newly ac-cepted nomenclature to describe theseveins is essential for medical reporting(1,2,16).

The aim of duplex US is to define allthe incompetent pathways and theirsources, which involve saphenous and

Table 2Leg Symptoms Associated withChronic Venous Insufficiency

AchingThrobbingHeavinessFatiguePruritusNight crampsRestlessnessGeneralized pain or discomfortSwelling

nonsaphenous veins, perforating veins,

g o


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 Dopplerimaging using frequencies of 7.5–10Mhz, although higher and lower fre-quencies may be used depending on thepatient’s 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, dorsiflexionby 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, the patient’s 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 intruncal 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 phlebec-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 patient’ssymptoms, 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 ofthe 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 ofshort 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-

Table 3Medical Indications for EVTA

ClinicalQuality of life affecting symptoms of vSkin changes associated with chronic v

Corona phlebectasiaLipodermatosclerosisAtrophie blanche pigmentation in thHealed or active ulcerationEdemaSuperficial thrombobophlebitis

AnatomicSignificant duplex US–documented reflStraight vein segmentIntra- or epifascial vein segment meetin

fluxing remnants of veins previously

treated with surgery, sclerotherapy, orEVTA.

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 ofthe 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 ofcompetent but enlarged superficial ve-nous segments has no proven medicalbenefit 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 incompetentperforating 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 skin

us insufficiency (see Table 2)us hypertension

aiter region of the lower leg

ther anatomic criteria

enoeno

e g

ux

injury (19).

he


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 ofan extrafascial vein such as the superfi-cial accessory GSV may lead to a higherincidence 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 vein’s 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

Table 4Relative Contraindications for EVTA

Pregnancy or nursing*Obstructed deep venous system inadequaLiver dysfunction or local anesthetic allerSevere uncorrectable coagulopathy, intrinSevere hypercoagulability syndromesInability to wear compression stockings s

hypersensitivity to the compressive malimitations to donning the stocking itse

Inability to adequately ambulate after theSciatic vein refluxNerve stimulator

* Secondary to concerns related to anesthblood effluent which may pass through t

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 throm-bobophlebitis in dependent tributary(ie, surface) varicose veins. This com-mon belief has not been substantiatedby 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-

to support venous return after EVTAlimiting local anesthetic agent useor iatrogenic

ndary to inadequate arterial circulation,ials, or musculoskeletal or neurologic

ocedure

drug use and related to vein or heatedplacenta to the fetus.

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 onwarfarin and a matched cohort of 24patients not on warfarin were selectedas a control group. The INR of the war-farin treated patients was 2.3–4.1. 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 44–62 J/cmrange. Low molecular weight heparinsare 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 lead 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 4–6 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 notbeen 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 vagal

tegysic

ecoterlfpr

etic

nerve stimulators may lead to a dys-


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 ofClosure Fast.

EVTA PROCEDURE

EVTA begins with a DUS evaluationby the treating physician to confirm thelocation and extent of the venous insuf-ficiency and to direct skin marking ofthe 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 asaccurate 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 veinjunctions; hypoplastic, aplastic, aneu-rysmal, or tortuous segments; refluxingperforating veins communicating withthe 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 more
than 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 anda 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 inmost 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 ensurethe device is intravenous, that the deviceallows access to the entire incompetentvenous segment, and that the workingend is not positioned in the deep 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 for accurate 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 mayalso be appropriate.

For SSV ablation, the tip of the deviceis positioned just beyond the take-offpoint of a competent thigh extension ofthe SSV or gastrocnemius vein, which-ever is more peripheral. If neither ofthese 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 accessory
GSV, 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 athermal 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 surrounding structures, 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 the sheathor external compression of the skin overthe tip of the ablation catheter duringthermal delivery 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 thejunctional end of a large vein but has notbeen 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 1–2weeks (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 ofthese 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 isbelieved important to complete the hemo-dynamic correction and maximize symp-tomatic improvement, eliminate incom-petent reservoirs that could facilitate the
development of new incompetent path-


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 parallelvenous trunks. Superficial thrombobo-phlebitis of large incompetent tributar-ies occurs following ablation of the un-derlying reflux without phlebectomy. Ithas been proposed that concurrent phle-bectomy 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 notbased 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 the of 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 heat–induced thrombus extension in the deep
veins at the junctions as well as in the
deep veins of the calf, the necessity ofevaluating all patients early for throm-bus cannot be substantiated.

Follow-up duplex US examinationsshould be periodically performed toevaluate 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 ofdisease 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 thismanuscript 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 with multiple different wave-lengths (Table 6) (23,28–64).

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 with 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 qualitativelysimilar.

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 1–2 cm ofthe treated vein beyond the SFJ or SPJremains patent. Post-EVTA patency ofsegments less than 5 cm long beyondthe junction are the most commonform of failure. Posttreatment patencyof 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 hasbeen 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/cm2), 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 rateby duplex US at 3 months was seen withmean fluence levels of approximately 30J/cm2 (60 J/cm) compared with fluencerates of 12 J/cm2 (24 J/cm). High ratesof vein occlusion and ultimate duplexUS disappearance was noted in a se-ries in which the thermal dose in each
segment of the GSV was tailored to the

d t


diameter in that segment (64). Theranges of energies used included 50J/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 success 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 85°C and apullback rate of 3 cm/min. Equivalentresults with observational studies at 6

Table 5Published Observational Series of RF A

Study, Year Limbs

Goldman et al, 2000 (30) 12Goldman et al, 2002 (31) 41Weiss et al, 2002 (32) 98

21Merchant et al, 2002 (33) 223

232142

Wagner et al, 2004 (34) 28Pichot et al, 2004 (28) 63Hingorani et al, 2004 (35) 66Merchant et al, 2005 (36)‡ 1161/61

473263133119117

Nicolini et al, 2005 (37) 68Merchant et al, 2005 (38) 98Mozes et al, 2005 (39) 56Puggioni et al, 2005 (40)‡ 53Dunn et al, 2006 (41) 85Ravi et al, 2006 (42) 159Almeida et al, 2006 (43)‡ 95/11Proebstle et al, 2008 (44)* 252

Note.—Clinical evaluations of laser ablatiand 1,320 nm) that are produced by seveof-concept studies including multiple cas* Study used the ClosureFast device.† Mean measurement.‡ The data for GSV and SSV were reporte

months have been demonstrated with

the use a target temperature of 90°C incombination with a faster catheterpullback rate (41). This has allowedenergy delivery times to be shortenedby 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 andbecome 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-

tion for Truncal Reflux (28,30–44)

VeinAnatomic

Success (%)Dup

GSV 100GSV 68GSV 96GSV 90GSV 87GSV 84GSV 85GSV 95GSV 90GSV —GSV/SSV —

— 87— 88— 84— 85— 87

GSV 88GSV 89GSV NRGSV/SSV 91GSV 90GSV 97GSV/SSV 95GSV 99

have been performed using laser energy omanufacturers. The published experienceeries (Table 6). NR � not reported.

ogether in this review.

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 recurrence 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 ad-junctive procedures used to eradicateany coexistent incompetent tributary

US Follow-up(mo)

MajorComplications (%)

6 06–24 0

6 124 NR— 612 NR24 NR3 3

25 NR— 16 (DVT)— —12 NR24 NR36 NR48 NR60 NR36 048 NRNR 81 NR6 NR

36 NR16† 0

6 0

veral wavelengths (810, 940, 980, 1,329,h this technique is composed of proof-

bla

lex

on f seral wites s

veins after EVTA.


Two comparisons of wavelength ofdelivered laser energy have been per-formed. One study compared 940 nm

Table 6Published Observational Series of Laser

Study, Year Limbs

Navarro et al, 2001 (45) 40Min et al, 2001 (46) 90Proebstle et al, 2003 (23) 104Oh et al, 2003 (47) 15Min et al, 2003 (48) 499Proebstle et al, 2003 (49) 39Perkowski et al, 2004 (50) 154

37Sadick et al, 2004 (51) 31Timperman 2004 et al, (52) 111Proebstle et al, 2004 (53) 106Goldman et al, 2004 (54) 24Proebstle et al, 2005 (55) 223Timperman et al, 2005 (56) 100Puggioni et al, 2005 (40) 77Kabnick et al, 2006 (57) 60Almeida et al, 2006 (43) 483/10Yang et al, 2006 (29) 71Kim et al, 2006 (58) 60Kavuturu et al, 2006 (59) 66Meyers et al, 2006 (60) 334

70Sadick et al, 2007 (61) 94Theivacumar et al, 2007 (62) 81Gibson et al, 2007 (63) 210Ravi et al, 2006 (42) 990

101Desmyttere et al, (2007) (64) 511

Note.—NR � not reported.* Survival determined by Kaplan-Meier a† EVL SFJ thrombus extension.‡ Mean measurement.

Table 7Anatomic Success at 1 Year*

TreatmentType

ReportedRange

(%)

ActionThreshold

(%)

RF ablationGSV 68–100 80SSV None 80

Laser ablationGSV 92–100 85SSV 92 85

Other veins† None 90

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

and 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 sideeffects 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 tobe independent of vein diameter inmany studies. However, a prospectiveconfirmation of this conclusion has notbeen performed.

No prospective comparison of RF ab-

lation for Truncal Reflux (23,29,40,42,43,4

VeinAnatomic

Success (%)Dup

GSV 100GSV 97GSV 90GSV 100GSV 98SSV 100GSV 97SSV 96GSV 97GSV NRGSV 90GSV 100GSV 92GSV 91GSV/SSV 94GSV 92GSV 98GSV 94GSV 95GSV? 97GSV *SSVGSV 96GSV 98SSV 100GSV 97SSV 90GSV 97 48

ysis.

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 Form–36 (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 those

64)

US Follow-up(mo)

Major ComplicationRate (%)

4.2 09 0

12 NR3 NR

17 06 NR

6–18 NR6–18 NR24 07 NR3 NR

6 (9‡) NR3 NR9 11 NR

12 NR16‡ 0.3†13 NR3 NR9 NR

36 NR

48 NR12 NR1.5 NR

30–42 NR30–42 NRlimbs at 4 y) NR

Ab 5–

lex

4

(34

nal

patients treated with either laser or RF


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

Table 8Comparison of EVTA and Surgery for G

Study, Year Type

Rautio et al, 2002 (73) RCT

Lurie et al, 2003 (64)* RCT

Lurie et al, 2005 (74)* RCT

Perala et al, 2005 (75)* RCT

de Medeiros et al, 2005(72)

Contralatera

Stotter et al, 2005 (76) RCT

Mekako et al, 2006 (68) Case compar

Vulsteke et al, 2006 (77) RCT

Hinchliffe et al, 2006 (78) RCT

Rasmussen et al, 2007 (69) RCT

Note.—APG � air plethysmography; AVligation and stripping; NR � not reported* Same patients.

ablation, regardless of the number of

patent tributary branches found at theSFJ.

Evaluation of the effectiveness ofEVTA in CEAP class 4–6 patients wasperformed in a retrospective review ofpatients 6 weeks after they were treatedwith RF ablation and laser (67). An 85%

Reflux (64,68,69,72–78)

Limbs Method Follow-up

1513

RFHL/S

50 d 1. V2. L3. R

eq4. D5. V

4436

RFHL/S

4 months 1. T2. R3. C

m4. V

at5. D6. E

4436

RFHL/S

2 y 1. E2. E3. C4. V

eq5. Q

an6. D

884436

RFHL/S

2 y 1. Eim

2. En

gs 2020†

HL/SHL/laser

8 weeks 1. M2. A

ev3. 70

eq202020

RFHL/SHL/cryo

1 y 1. D2. V3. C

14. R

n 6270

HL/SLaser

12 weeks 1. SFat

2. A3. V

8480

HL/SLaser

NR 1. Qfo

— HL/S —RF

6867

LaserHL/S

6 months 1. EA

� Aberdeen Varicose Veins QuestionnairOL � quality of life; RCT � randomized

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-

ults for RF Ablation Versus Surgery

pain score and med use less at 14 dsick leaveD-36 pain score lower at 1 week butl laterlex US closure rate, 100%and complications no differentto normal activity, 1 d vs 4 d

rn to work, 5 d vs 12 dQ2 better for RF at 1 week and 4ths

better for RF at 1 and 3 weeks, equalmonthslex US closure rate, 91%l complicationsl rates of new vessels (2% vs. 11%)l recurrent varicose veins (14% vs. 21%)P improvement equal

better with RF at 72 h and 1 weeks,l at 4 months and 2 ybetter with RF at 72 h, 1 weeks, and 1

2 y, equal at 3 weeks and 4 monthslex US: no reflux segments of GSV invs 92%l VCSS, VDS, VSDS scoreovementsl recurrent varicose veins andascularity

swelling/bruising with surgeryd, equivalent outcomes by QOL

ation, APGfavored laser, 10% felt treatments werealent

lex US: 90/100/90pain less for RF ablation

Q activity impairment better with RF to

/RTA better for RFbetter for laser at 1 and 6 weeks, equal

weeksQ better for laser at 1, 6, and 12 weeks

improvements at 1 ,6, and 12 weeks, medication use, and sick days betterVLT

—

valent technical success, VAS, VSS,Q, SF-36, duplex US

L � high ligation; HL/S � hightrolled trial.

SV

Res

ASessANua

upSSimeetuIVIonCSS4

upquaquaquaEACSSua

OLd

up%

quapr

quaeov

l le oret 60alu%uiv

upASIVIyTW

iso -3612

VVCSSOLr E

quiVV

VQ e; H; Q con

mented improvement in air plethys-


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 withulcer healing with a combination of ei-ther RF ablation or laser and microphle-bectomy 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 ofpractice goes thought an evolution fromproof-of-concept studies to clinical com-parisons to other existing standards ofpractice. 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 ofrecurrence 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 scores 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 surgery
and 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 bepublished (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). Thisstudy’s 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 at 1 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 and12 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 microphle-bectomy and 124 with conventionalHL/S and microphlebectomy comparedthe QOL of the postprocedural period ofboth procedures (77). The study demon-strated significantly less postoperativemorbidity for the laser procedure using
the 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 limbstreated with HL/S and 62 with laserwas performed with both groups beingtreated with only tumescent anesthesia(69). The preliminary report of this on-going study evaluated the patients up 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 laserbut by 3 months both procedures dem-onstrated significant improvements inall indices compared with pretreatmentbaselines; 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.

COMPLICATIONS

Adverse 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 ofnonsteroidal 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 blinded
comparison has not been performed.


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 hasbeen managed in most series with non-steroidal antiinflammatory medication,graduated compression hose, and am-bulation. Anecdotally, superficial phle-bitis seems to be more common in larg-er-diameter dependent varicose veins orin varicose veins that have their inflowand 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 hasbeen shown to be higher in low-volumecenters compared with high-volumecenters (36). The nerves at highest riskinclude the saphenous nerve, adjacent

Table 9Complications of EVTA*

Complication

ReportedRange

(%)

SuggestedThreshold

(%)

DVTRF ablation

GSV 0–16 5SSV NR 5

Laser ablationGSV 0–8 2SSV 0–6 5

Paresthesia(temporary andpermanent)RF ablation

GSV 0–15 10SSV NR 10

Laser ablationGSV 0–12 10SSV 0–10 10

Skin burnRF ablation

GSV 0–7 1SSV NR 1

Laser ablationGSV 0–12 1SSV 0 1

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

to 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 ordysesthesia, most of which are transient.The nerve 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 laser (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. Anextremely high rate of nerve injuries andskin burns were reported in the articleby 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 ofabove-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 RF ablation may 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 lower part of the SSV may benecessary in many patients to treat toeliminate symptoms or skin diseasecaused by reflux to the ankle. A retro-spective review (82) demonstrated thatbelow-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 5–10 cmmay accomplish clinical benefit and po-tentially avoid saphenous nerve injuryrisk in patients with reflux to the medialmalleolus.

Skin burns following EVTA havebeen 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 oftumescent technique during RF ablationEVTA. The early experience had rates ashigh as 4% (33) that decreased to almostzero as the use of tumescent anesthesiabecame a standard of practice.

DVT following EVTA is unusual.DVT can occur as an extension ofthrombus 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 extensionfor 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 laser 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 thatthat 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 2–4 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-


ripheral deep veins after EVTA has notbeen well evaluated, as the results ofroutine 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 1–3-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 is common and of-ten an early event (8,85). A study wasperformed with the principal endpointcomparing the number of vessels seenbefore 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 tributaries in continuity with theSFJ (59%) (70).

Anecdotal reports of laser fiber frac-ture or retained venous access sheathshave been made to the device manufac-turers, and a case report exists describ-ing a retained 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 ofthese 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 popliteal arterybranch 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 ofthe 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.

CONCLUSIONS

EVTA is one of several potentialtreatment 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 ofthe SIR Standards Division. All other authorsare listed alphabetically. Other members ofthe Standards of Practice Committee and SIRwho participated in the development of thisclinical practice guideline are as 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, Darryl A. 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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SIR DISCLAIMER

The clinical practice guidelines of the Society of Interventional Radiology attempt to define practice principles thatgenerally should assist in producing high quality medical care. These guidelines are voluntary and are not rules. Aphysician may deviate from these guidelines, as necessitated by the individual patient and available resources. Thesepractice guidelines should not be deemed inclusive of all proper methods of care or exclusive of other methods ofcare that are reasonably directed towards the same result. Other sources of information may be used in conjunctionwith these principles to produce a process leading to high quality medical care. The ultimate judgment regarding theconduct of any specific procedure or course of management must be made by the physician, who should consider allcircumstances relevant to the individual clinical situation. Adherence to the SIR Quality Improvement Program willnot assure a successful outcome in every situation. It is prudent to document the rationale for any deviation from thesuggested practice guidelines in the department policies and procedure manual or in the patient’s medical record.

CME TEST QUESTIONSExamination available at http://directory.sirweb.org/jvircme

The CME questions in this issue are derived from Khilnani et al, Multi-Society Consensus Quality Improvement Guidelinesfor the Treatment of Lower Extremity Superficial Venous Insufficiency With Endovenous Thermal Ablation.

1. Which of the following terms best describes a superficial vein running from the lateral aspect of the foot anddraining into the popliteal vein?a. Great saphenous veinb. Giacomini veinc. Posterior accessory great saphenous veind. Small saphenous vein

2. A patient you are seeing in the vein clinic for consideration of treatment of superficial venous insufficiencyis noted to have brownish darkening of the skin and clusters of small (�1 mm width) intradermal venulesat the medial ankle. What CEAP (Clinical severity, Etiology, Anatomy, Pathophysiology) clinical grade wouldyou record for this patient?a. Grade 3b. Grade 4ac. Grade 4bd. Grade 5

3. Which of the following treatment strategies for symptomatic superficial venous insufficiency does thisquality improvement guideline discourage?a. Treatment of competent vein segments below an incompetent vein segmentb. Treatment of incompetent superficial truncal veins in the setting of deep vein refluxc. Treatment of an incompetent truncal vein with reflux of greater than 0.5 sec durationd. Treatment of a great saphenous vein measuring 1.0 cm in diameter

4. What is the suggested action threshold for skin burn following endovascular thermal ablation for lowerextremity venous insufficiency?a. 0.5%b. 1%c. 2%d. 5%

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Multi-society Consensus Quality Improvement Guidelines for ... · remove them. Endovenous thermal ablation (EVTA) of the saphenous veins has been used by physicians since the late