multi-disciplinary quality improvement guidelines for the ... · sanjoy kundu, md, frcpc, clement...

Standards of Practice

Multi-disciplinary Quality ImprovementGuidelines for the Treatment of LowerExtremity Superficial Venous Insufficiencywith Ambulatory Phlebectomy from the Societyof Interventional Radiology, CardiovascularInterventional Radiological Society of Europe,American College of Phlebology and CanadianInterventional Radiology AssociationSanjoy Kundu, MD, FRCPC, Clement J. Grassi, MD, Neil M. Khilnani, MD, Fabrizia Fanelli, MD,

Sanjeeva P. Kalva, MD, Arshad Ahmed Khan, MD, J. Kevin McGraw, MD, Manuel Maynar, MD,Steven F. Millward, MD, Charles A. Owens, MD, Leann S. Stokes, MD, Michael J. Wallace, MD,Darryl A. Zuckerman, MD, John F. Cardella, MD, and Robert J. Min, MD, for the Cardiovascular InterventionalRadiological Society of Europe, American College of Phlebology, and Society of Interventional RadiologyStandards of Practice Committees

J Vasc Interv Radiol 2010; 21:1–13Abbreviations: AP � ambulatory phlebectomy, CEAP � clinical status, etiology, anatomy, and pathophysiology [classification], CVD � chronic venous disease,
DVT � deep vein thrombosis, EVTA � endovenous thermal ablation, GSV � great saphenous vein, SSV � small saphenous vein, VCSS � venous clinical sever-ity score
PREAMBLE

LOWER extremity venous insufficiency isa heterogeneous medical condition whose

From the Vein Institute of Toronto (S.K.), Toronto;Department of Radiology (S.F.M.), Peterborough Re-gional Health Centre, Peterborough, Ontario, Canada;Department of Radiology (C.J.G.), Boston HealthcareSystem VAMC, Boston, Massachusetts; Department ofRadiology (S.P.K.), Massachusetts General Hospital,Boston, Massachusetts; Geisinger Health System(J.F.C.), Danville, Pennsylvania; Department of Inter-ventional Radiology (A.A.K.), Washington HospitalCenter, Bethesda, Maryland; Cornell Vascular(N.M.K.) and Department of Radiology (R.J.M.), NewYork Presbyterian Hospital–Weill Cornell MedicalCenter, New York, New York; Department of Inter-ventional Radiology (J.K.M.), Riverside MethodistHospital, Columbus; Department of Radiology(D.A.Z.), University of Cincinnati Hospital, Cincinnati,Ohio; Departments of Radiology and Surgery(C.A.O.), University of Illinois Medical Center, Chi-cago, Illinois; Department of Radiology and Radiolog-ical Sciences (L.S.S.), Vanderbilt University MedicalCenter, Nashville, Tennessee; Department of Interven-
tional Radiology (M.J.W.), The University of TexasM. D. Anderson Cancer Center, Houston, Texas; Inter-
spectrum ranges from cosmetic abnor-malities including spider telangiectasias tovaricose veins with or without associatedsigns and symptoms including severe

ventional Radiology Unit (F.F.), Department of Radio-logical Sciences, “SAPIENZA” University of Rome,Rome, Italy; and Las Palmas de Gran Canaria Univer-sity (M.M.), Hospiten Rambla Hospital, Santa Cruz deTenerife, Spain. Received December 6, 2008; final revi-sion received January 13, 2009; accepted January 18,2009. Address correspondence to S.K., c/o DebbieKatsarelis, 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 commit-tee of the Society of Interventional Radiology (SIR). Aftercompletion, the document was presented to the Cardio-vascular and Interventional Radiological Society of Eu-rope and American College of Phlebology, whichmade recommendations and offered their endorse-ment for this standard of practice position statement.

© SIR, 2010

DOI: 10.1016/j.jvir.2009.01.035

edema, skin ulceration, and subsequentmajor disability. Venous hypertensioncaused by incompetent valves in the su-perficial veins is by far the most com-mon cause of this condition. This docu-ment will review the appropriate meansby which ambulatory phlebectomy (AP)is to be used to maximize the benefit forpatients who undergo the procedure.

The membership of the Society ofInterventional Radiology (SIR) Stan-dards of Practice Committee repre-sents experts in a broad spectrum ofinterventional procedures from boththe private and academic sectors ofmedicine. Generally, Standards ofPractice Committee members dedicatethe vast majority of their professionaltime to performing interventional pro-cedures; as such they represent a validbroad expert constituency of the sub-ject matter under consideration forstandards production. Representativesfrom the Cardiovascular and Interven-tional Radiology Society of Europe
(CIRSE) and the American College of
1

mailto:[email protected]

2 • Guidelines for Phlebectomy for Lower-extremity Venous Insufficiency January 2010 JVIR

Phlebology broaden the expertise toinclude multispecialty and interna-tional experience.

Technical documents specifying theexact consensus and literature reviewmethodologies as well as the institu-tional affiliations and professional cre-dentials of the authors of this docu-ment are available upon request fromSIR, 3975 Fair Ridge Dr., Suite 400North, Fairfax, VA 22033.

METHODOLOGY

SIR produces its Standards of Prac-tice documents using the followingprocess. Standards documents of rele-vance and timeliness are conceptual-ized by the Standards of Practice Com-mittee members. A recognized expertis identified to serve as the principalauthor for the standard. Additionalauthors may be assigned dependentupon the magnitude of the project.

An in-depth literature search is per-formed using electronic medical litera-ture databases. Then a critical review ofpeer-reviewed articles is performedwith regards to the study methodology,results, and conclusions. The qualitativeweight of these articles is assembled intoan evidence 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 evidence of literature isweak, conflicting, or contradictory,consensus for the parameter is reachedby a minimum of 12 Standards ofPractice Committee members using amodified Delphi consensus method(Appendix A) (1,2). For purposes ofthese documents, consensus is definedas 80% Delphi participant agreementon a value or parameter.

The draft document is critically re-viewed by the Standards of PracticeCommittee members, either by tele-phone conference calling or face-to-facemeeting. The finalized draft from theCommittee is sent to the SIR member-ship for further input/criticism during a30-day comment period. These com-ments are discussed by the Standards ofPractice Committee, and appropriate re-visions made to create the finished stan-dards document. Prior to its publicationthe document is endorsed by the SIRExecutive Council.

The current guidelines are written tobe used in quality improvement pro-
grams to assess AP for lower extremity
superficial venous insufficiency. Themost important elements of care are(i) pretreatment evaluation and patientselection (ii), performance of the proce-dure, and (iii) postprocedure follow-upcare. The outcome measures or indica-tors for these processes are indications,success rates, and complication rates.Although practicing physicians shouldstrive to achieve perfect outcomes, inpractice all physicians will fall short ofideal outcomes to a variable extent.Therefore, in addition to quality im-provement case reviews conducted afterindividual procedural failures or com-plications, outcome measure thresholdsshould be used to assess treatmentsafety and efficacy in ongoing qualityimprovement programs. For the pur-pose of these guidelines, a threshold is aspecific level of an indicator that, whenreached or crossed, should prompt areview of departmental policies andprocedures to determine causes and toimplement changes, if necessary.Thresholds may vary from those listedhere; for example, patient referral pat-terns and selection factors may dictate adifferent threshold value for a particularindicator at a particular institution.Therefore, setting universal thresholdsis very difficult and each department isurged to adjust the thresholds as neededto higher or lower values to meet itsspecific quality improvement programsituation.

INTRODUCTION

During the past decade the scope oftreatments for lower-extremity venousinsufficiency has undergone dramaticevolution and change. AP, microsurgi-cal phlebectomy, office phlebectomy,ambulatory stab avulsion phlebectomy,and Muller’ phlebectomy are all syn-onyms for an outpatient procedure bywhich dilated incompetent surface veinscan be avulsed through multiple stabincisions. This technique was first de-scribed by Aulus Cornelius Celsus (25BC to 45 AD) and reinvented by RobertMuller, a Swiss dermatologist, in themid-1950s. This procedure has been per-formed for incompetent tributarybranches of the great or small saphe-nous veins, perforators, reticular veins,veins supplying telangiectasias, facialveins, and foot veins (3–13). Small seg-ments of veins are removed throughminute skin incisions (1–3 mm) or nee-
dle puncture, with the goal of complete
and definitive eradication of the targetvein with minimal damage to the skin(14–24).

Interventional physicians have be-come increasingly involved in the as-sessment and treatment of lower-ex-tremity venous insufficiency with theadvent of endovenous thermal abla-tion (EVTA) for the treatment of trun-cal vein incompetence (25). An impor-tant consideration in the treatment oftruncal reflux is the appropriate treat-ment of the incompetent and dilatedtributary and perforator veins whereAP is a key adjunct in the treatmentalgorithm.

These guidelines are written to beused in quality improvement programsto assess AP. The most important pro-cesses of care are (i) patient selection, (ii)performing the procedure, and (iii)monitoring the patient. The outcomemeasures or indicators for these pro-cesses are indications, success rates, andcomplication rates. Outcome measuresare assigned threshold levels.

DEFINITIONS

Although practicing physiciansshould strive to achieve perfect out-comes (eg, 100% success, 0% complica-tions), in practice all physicians will fallshort of this ideal to a variable extent.Thus indicator thresholds may be usedto assess the efficacy of ongoing qualityimprovement programs. For the pur-poses of these guidelines, a threshold isa specific level of an indicator whichshould prompt a review. “Procedurethresholds” or “overall thresholds”reference a group of indicators for aprocedure, eg, major complications.Individual complications may also beassociated with complication-specificthresholds. When measures such as in-dications or success rates fall below a(minimum) threshold, or when compli-cation rates exceed a (maximum) thresh-old, a review should be performed todetermine causes and to implementchanges, if necessary. Thresholds mayvary from those listed here; for example,patient referral patterns and selectionfactors may dictate a different thresholdvalue for a particular indicator at a par-ticular institution. Thus, setting univer-sal thresholds is very difficult and eachdepartment is urged to alter the thresh-olds as needed to higher or lower val-ues, to meet its own quality improve-
ment program needs.

em

Kundu et al • 3Volume 21 Number 1

Complications can be stratified onthe basis of outcome. Major complica-tions result in admission to a hospitalfor therapy (for outpatient proce-dures), an unplanned increase in thelevel of care, prolonged hospitaliza-tion, permanent adverse sequelae, ordeath. Minor complications result inno sequelae; they may require nominaltherapy or a short hospital stay forobservation (generally overnight).

Anatomy

Superficial veins.—The veins of thelower extremity that are superficial tothe fascia surrounding the muscularcompartment are considered the su-perficial veins. These include innu-merable venous tributaries known ascollecting veins as well as the greatsaphenous vein (GSV) and small sa-phenous vein (SSV) and their major

Figure. Superficial and deep venous syst

named tributaries (Fig).

Deep veins.—The deep veins arethose found deep to the muscular fas-cia. These include the tibial, peroneal,popliteal, femoral, and iliac veins.

GSV.—An important component ofthe superficial venous system, theGSV begins on the dorsum of the foot,and ascends along the medial aspect ofthe leg to ultimately drain into thefemoral vein near the groin crease.This vein resides in a space deep to thesuperficial and superficial to the deepfascia. This location is known as thesaphenous space. The word “great”replaces “greater” or “long” by inter-national consensus (26,27).

SSV.—Another important superfi-cial vein, the SSV begins on the lateralaspect of the foot and ascends up themidline of the calf. In as many as twothirds of cases it drains into the popli-teal vein and in at least one third ofcases it extends more cephalad. The

of the lower extremity.

SSV also resides in the saphenous

space. The word “small” replaces“lesser” or “short” by internationalconsensus (26,27).

Anterior and posterior accessoryGSVs.—The anterior and posterior ac-cessory GSVs are located in the saphe-nous space and travel parallel and ante-rior or posterior to the GSV. The anterioraccessory GSV is much more common.

Giacomini vein.—The Giacomini veinis an intersaphenous vein that is a com-munication between the GSV and SSV.It represents a form of SSV cephaladextension that connects the SSV with theposterior circumflex vein of the thigh, aposterior tributary of the proximal GSV.

Truncal veins.—The term “truncalveins” refers to the saphenous veins andtheir intrafascial straight primarytributaries.

Reticular vein.—The term “reticularvein” refers to collector veins connectingspider veins or skin capillary networksto the superficial venous system or toperforating veins. These veins may be-come enlarged and appear as “green”veins under the skin surface.

Spider vein.—The term “spider vein”refers to fine enlarged capillary net-works on the skin surface having aspider-like appearance. Spider veinsmay be red or a blue color.

Disease Process

Venous reflux.—Veins contain valvesthat 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 recanalization with or with-out valvular incompetence in that vas-cular segment.

Chronic venous disease.—Chronic ve-nous disease (CVD) is the clinical entitythat results from chronic venous hyper-tension (28). The overwhelming major-ity of patients with stigmata of venoushypertension have primary (or degener-
ative) disease of the vein wall with re-


sultant valvular dysfunction in the su-perficial veins, which leads to reflux(29). This subset of CVD is known assuperficial venous insufficiency. Patho-physiologically significant reflux of theGSV or in one of its primary tributariesis present in 70%–80% of patients withchronic venous insufficiency. SSV refluxis found in 10%–20% and nonsaphenoussuperficial reflux is identified in 10%–15% of patients (30,31). Venous obstruc-tion, deep vein reflux, muscular pumpfailure, and congenital anomalies aremuch less common causes. Venous ob-struction is the most common of theseother causes of CVD and is almost al-ways the result of previous deep veinthrombosis (DVT). It is initially an ob-structive disease but usually progressesto a combination of obstruction and su-perficial and deep venous reflux (32).Reflux or outflow vein obstruction leadto an increase in pressure in the super-ficial venous system. The veins them-selves can dilate if unconstrained andthe pressure causes stretching of recep-tors in the vein wall, which leads todiscomfort to the patient. The pressureitself can adversely affect local tissuesand metabolic processes leading todamage in the vein wall, the skin, andsubcutaneous tissues.

Neovascularization.—Neovascular-ization describes the presence of multi-ple small tortuous connections betweenthe saphenous stump or the femoralvein and a residual saphenous vein orone its patent tributaries (new or dilatedpreexisting vessels outside the origi-nally treated venous wall) that can occurfollowing surgical ligation of the saphe-nofemoral junction or less commonlythe saphenopopliteal junction. This is avery common pattern of recurrence fol-lowing surgical ligation of the GSV andits tributary veins near the saphe-nofemoral junction and presents as atangle of blood vessels in the vicinity ofthe saphenofemoral junction.

Clinical status, etiology, anatomy, andpathophysiology (CEAP) classification.—“CEAP” is an acronym for a descriptiveclassification system that summarizesthe disease state in a given patient withlower-extremity venous insufficiency(29,33). The system describes the clinicalstatus, etiology, anatomy, and patho-physiology of the problem. This clinicalstatus scale is the most frequently usedcomponent in grading patients based onphysical observations of disease severity
(Table 1).
Venous clinical severity score (VCSS).—VCSS is an additional means of gradingthe spectrum of disease severity (34,35).The VCSS allows more detailed descrip-tion of the severity of attributes ofchronic venous insufficiency comparedwith the CEAP system. The VCSS is animportant complement to CEAP in re-porting clinical success of an interven-tion (Table 2).

TREATMENT METHODS

AP

Also known as microphlebectomy orstab phlebectomy, AP is a procedure bywhich varicose tributaries are removedwith small hooks through 3–4-mm skinnicks using only local anesthesia.

EVTA

EVTA refers to the procedure bywhich thermal energy is endovenouslydelivered to the lumen of a vein with thegoal of causing the veins to irreversiblyocclude. It is usually employed to elimi-nate incompetent superficial truncal veinsresponsible for the manifestations of su-perficial venous insufficiency. The associ-ated varicose tributary and reticular veinsand telangiectasias are treated separatelywith adjunctive therapies including APand compression sclerotherapy.

Sclerotherapy

Sclerotherapy is a procedure bywhich a medication is injected into avein in order to irreversibly occlude it.This is usually done with a syringeand needle, although these medica-tions can be injected with a catheter orintravenous cannula.

Duplex Ultrasound

Duplex ultrasound (US) is the mostimportant imaging test to investigatepatients with CVD. It uses grayscaleimaging to visualize the venous anat-omy and evaluate patency. Color andpulse-wave Doppler imaging is usedto investigate direction and velocity ofblood flow through the veins to iden-tify reflux. Duplex US to evaluateCVD is much more complicated andtime-consuming than to detect DVT,as it also involves the analysis of seg-mental competence of all the deep, su-
perficial, and perforator veins.
Tumescent Anesthesia

The term “tumescent anesthesia” re-fers to the delivery of large volumes ofdilute local anesthetic agent to create alarge region of anesthesia. This form ofdelivery typically causes a localizedswelling, 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.

Clinical Success

Clinical success is defined as an im-provement in the clinical status of a pa-tient as defined by one of the objectiveassessment instruments, such as theCEAP or VCSS classification, by at leastone grade. In practice, most patientstreated with AP will also be treated withadjunctive EVTA or compression sclero-therapy. It is generally believed that clini-cal success will be dependent on the thor-oughness of the adjunctive proceduresthat are performed, as well as the successof AP.

COMPLICATIONS

Paresthesia and Dysesthesia

Paresthesia and dysesthesia describethe loss or aberration, respectively, ofnormal sensory perception. Injury to thesaphenous or sural nerves adjacent tothe GSV, SSV, or tributary veins canlead to these sensory disturbances.

Deep Vein Thrombophlebitis

Deep vein thrombophlebitis is throm-bosis in the veins deep to the muscularfascia.

Superficial Thrombophlebitis

Superficial thrombophlebitis isthrombosis in veins superficial to themuscular fascia. The veins involved areusually the subcutaneous collectingveins, which are the tributaries of thesaphenous veins. The GSV or SSV mayor may not be thrombosed.

Arteriovenous Fistula

An arteriovenous fistula is an abnor-mal connection between an artery and a
vein. Such a connection may be created

6,S


iatrogenically by a penetrating injury or aspart of a primary vascular disease process.

Toxicity Related to TumescentAnesthesia

Toxicity can develop from the useof large doses of lidocaine used forperivenous anesthesia. Close follow-upwith monitoring and management ofancillary therapy is appropriate for theradiologist.

PHYSICIAN CREDENTIALING

Before treatment, all patients with

Table 1CEAP Classification of CVD

Class

Clinical classificationC0C1C2C3C4

C4aC4b

C5C6

Symptom classificationS

AEtiologic classification

EcEpEsEn

Anatomic classificationAsApAdAn

Pathophysiologic classificationPrPoPr,oPn

Level of investigationLevel I

Level II

Level III

ExampleA patient has painful swelling of the le

May 17, 2004, showed axial refluxveins, and axial reflux in the femor

Classification according to basic CEAP: C

CVD should undergo a through clini-

cal evaluation by a physician who isappropriately trained in the care of ve-nous diseases. The body of knowledgerequired includes a thorough under-standing of venous anatomy, physiol-ogy, pathophysiology, diagnosis, du-plex US, and treatment options. Therequisite knowledge and clinical expe-rience can be acquired through train-ing in Accreditation Council forGraduate Medical Education–recog-nized (or approved) postgraduateresidency or fellowship programs.Knowledge and skills can also be ac-quired through continuing medicaleducation and/or mentored clinical

Des

No visible or palpable signs of venousTelangiectasias or reticular veinsVaricose veins, distinguished from reticEdemaChanges in skin and subcutaneous tissuEczema, pigmentation (and additionallyLipodermatosclerosis or atrophie blanchHealed venous ulcerActive venous ulcer

Symptomatic, including ache, pain, tighmuscle cramps, and other complaints

Asymptomatic

CongenitalPrimarySecondary (postthrombotic)No venous cause identified

Superficial veinsPerforator veinsDeep veinsNo venous location identified

RefluxObstructionReflux and obstructionNo venous pathophysiology identifiabl

Office visit, with history and clinical exhand-held Doppler scanner

Noninvasive vascular laboratory testingcolor scanning, with some plethysmo

Invasive investigations or more compledescending venography, venous pres

nd varicose veins, lipodermatosclerosis, ahe great saphenous vein above and belownd popliteal veins. There are no signs of p

, Ep,As,p,d, Pr (2004-05-17, L II)

experience (11).

PRETREATMENTASSESSMENT

Clinical evaluation of the patient be-fore treatment in an outpatient settingprovides the physician an opportunityto perform a focused venous historyalong with a relevant medical history,followed by focused venous physicalexamination and evaluation of the pa-tient’s venous system with Duplex US.Only after such an examination can thephysician communicate the appropriatetreatment options. Patients with duplexUS–documented truncal incompetencehave the option of selecting EVTA, surgi-

tion

ease

r veins by a diameter �3 mm

rona phlebectasia)

ss, skin irritation, heaviness, andributable to venous dysfunction

ination, which may include use of a

hich now routinely includes duplexphic method added as desired

aging studies, including ascending ande measurements, CT, or MR imaging

active ulceration. Duplex scanning onknee, incompetent calf perforator

tthrombotic obstruction.

crip

dis

ula

eco

e

tneatt

e

am

, wgrax imsur

g, a ndof t theal a os

cal high ligation and/or stripping, or US-


guided sclerotherapy to initiate treatment.Patients also have the option of conserva-tive treatment with graded medical com-pression stockings. Subsequently or con-currently the patient may undergo AP orsclerotherapy of the dilated tributarybranches of the GSV or SSV.

Medical History

A complete medical history of thepresenting venous problem, previoustherapy and response, previous historyof thrombosis, comorbidities, medica-tions, allergies, and any pertinent familyhistory should be obtained from the pa-tient. Chronic venous insufficiencycauses symptoms in many patients thatcan impact their quality of life. Thesesymptoms are summarized in Table 3.All of these symptoms are worsenedwith prolonged standing or sitting, im-prove with movement, and are most no-ticeable at the end of the day. In long-standing cases, patients may developskin changes in the form of eczema,corona phlebectasia, pigmentation,

Table 2Venous Clinical Severity Score

Attribute 0 (Abse

Pain None

Varicose veins None

Venous edema None

Skin pigmentation None or focintensity

Inflammation None

Induration None

Number of active ulcers 0Active ulceration duration NoneActive ulcer, size NoneCompressive therapy Not used or

compliant

and lipodermatosclerosis, and in the

worst cases may form ulcers. A fam-ily and coagulation history searchingfor evidence of a hypercoagulablestate should also be obtained. Labo-ratory and further hematologic eval-uation is strongly recommended forpatients with a history suggestive ofa hypercoagulable state.

Physical Examination

A complete physical examination of

1 (Mild)

Occasional, not restrictingactivity or requiringanalgesics

Daily,limianal

Few, scattered branchvaricose veins

Multipveinor th

Evening ankle only Afternank

low)

Diffuse, but limited inarea and old (brown)

Diffusgait(lowrece(pur

Mild cellulitis, limited tomarginal area aroundulcer

Modeinvoarea

Focal, circum malleolar(�5 cm)

Mediathan

1�3 mo �3 mo�2 cm diameter 2–6 cm

t Intermittent use ofstockings

Wearsmos

Table 3Symptoms Associated with ChronicVenous Insufficiency

AchingThrobbingHeavinessFatiguePruritusNight crampsRestless legsGeneralized pain or discomfortLeg swelling

the patient below the level of the umbi-

licus should be performed. This shouldbe performed in the standing position(except for nonambulatory patients) andshould include the lower extremities aswell as the lower pelvis in patients inwhom iliac vein occlusion is possible.Visible vein abnormalities including tel-angiectasias, reticular veins, and vari-cose veins should be documented.Edema of the extremities should be doc-umented and calf and ankle diametermeasurements obtained in cases ofquestionable edema. Careful attentionshould be directed at the skin near themedial and lateral malleolus of the an-kle, as this region is most vulnerable tothe effects of chronic venous hyperten-sion. Manifestations of CVD such as co-rona phlebectasia, eczema, lipodermato-sclerosis, and ulceration should also bedocumented. It is suggested that a stan-dardized means of clinically assessingthe severity of the effects of thechronic venous hypertension, such asthe CEAP scale, be used to documentone’s findings (Table 1) (29). In addi-tion, it is strongly recommended that a

oderate) 3 (Severe)

derate activityon, occasionalics

Daily, severe limitingactivities orrequiring regularuse of analgesics

GSV varicoseonfined to calf

Extensive: thigh andcalf or GSV andSSV distribution

n edema, above Morning edemaabove ankle andrequiring activitychange, elevation

ver most ofistribution

one third) origmentation

)

Wider distribution(above lower onethird) and recentpigmentation

cellulitis,s most of gaiterwer 2/3)

Severe cellulitis(lower 1/3 andabove) orsignificant venouseczema

r lateral, lesswer third of leg

Entire lower third ofleg or more

2 �21 y Not healed �1 y

iameter �6 cm diameterstic stockings

aysFull compliance:

stockings andelevation

nt) 2 (M

motatiges

le:s cighoo

le

al,(tan

e oer dernt pple

ratelve(lo

l olo

, �d

no elat d

written documentation of the history,


clinical and duplex US examinationfindings be created for each patient,including a discussion of the impres-sion and clinical recommendations.Photographs of the visible findings arealso helpful to document the severityand extent of the disease before treat-ment.

Duplex US

Duplex US is essential in all pa-tients with CEAP classification of C2or higher and in patients with clinicalsymptoms of leg pain, swelling, ornight cramps to identify reflux andpatency and to establish the pattern ofdisease. The technique of duplex USfor CVD is different than for the eval-uation of lower-extremity DVT. Thegoals, objectives, and technique of thisexamination have been reviewed in aconsensus statement by the Union In-ternationale de Phlebologie, AmericanCollege of Phlebology, and SIR in sev-eral recent publications (38–40). Dur-ing this examination, it is important toevaluate the anatomy and the physiol-ogy of both the superficial and deepvenous systems. A thorough knowl-edge of the anatomy of the superficialvenous system and its common vari-ants is necessary. Accurate use of thenewly accepted nomenclature to de-scribe these veins is essential for med-ical reporting (26,27,39). The aim ofthe duplex US is to define all of theincompetent pathways and theirsources, which involve saphenousand nonsaphenous veins, perforat-ing veins, and deep veins. The eval-uation should also include an assess-ment of the patency of the deepvenous system, including the femo-ral and popliteal vein.

The necessary equipment includesgrayscale US and pulse-wave Dopplerimaging equipment using frequencies of7.5–10 Mhz, although higher and lowerfrequencies may be used depending onthe patient’s morphology. Color Dopp-ler imaging is very useful and readilyavailable as a package with most unitsincluding pulse-wave Doppler equip-ment. Duplex US should be performedin the standing position and the exam-iner should thoroughly evaluate theGSV, SSV, their named tributaries, and
the deep veins for both reflux and ob-
struction. Venous reflux is diagnosedwhen there is reversal of flow from theexpected physiologic direction for morethan 0.5 seconds following a provoca-tive maneuver to create physiologicflow. These maneuvers include calf orfoot compression by the examiner, dor-siflexion by the patient, or a Valsalvamaneuver to assess for competency ofthe saphenofemoral junction or saphe-nopopliteal junction. A standardized re-port should be created and used to de-scribe the findings for each examinationin each patient. The use of diagramssignificantly enhances the future under-standing and communication of impor-tant clinical findings.

Ancillary Imaging

In unique or isolated clinical situa-tions, patients may require further im-aging to characterize venous obstruc-tion, reflux, or venous anomalies in thepelvis or lower extremity such as a con-ventional intravenous or endovascularcatheter contrast venogram, or com-puted tomographic (CT) or magneticresonance (MR) venogram. 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 (Table 1) (29).

INDICATIONS ANDCONTRAINDICATIONSFOR AP

Indications for AP

The indications for AP includeasymptomatic varicose veins for cos-metic purposes, symptomatic varicoseveins not responding to conservativetreatment, and patients with complica-tions of varicose veins such as superfi-cial thrombophlebitis, recurrent throm-bophlebitis, and bleeding (22,41,42).Varicose branch tributary veins close tothe skin surface, such as major tributarybranches of the GSV or SSV such as theanterior thigh circumflex vein, posteriorthigh circumflex vein, or anterior acces-sory great saphenous vein, are good in-dications for AP. These veins may also
be treated with sclerotherapy or EVTA
if marked tortuosity is absent. The GSVand SSV are not appropriate veins forAP as they lie below the superficial fas-cia and are too deep for AP. Varicosegroin pudendal veins and labial veinsare also appropriate indications for AP.Incompetent dilated perforator veinsclose to the skin surface are also candi-dates for AP. Dilated reticular veins ofthe popliteal area, lateral thigh and leg,ankle, and dorsal venous network of thefoot are less common indications for AP.Networks of thick blue spider veinsmay also be removed by AP. Body areasother than the lower extremity whereAP may be used include dilated perior-bital, temporal, or frontal facial venousnetworks, and dilated veins of the ab-dominal wall, arms, or the dorsum ofthe hands (44). However, it should benoted that removal of functional veinsfor purely aesthetic purposes is a subjectof debate, and a practice avoided bysome physicians in an effort to preservefunctional veins. The AP technique mayalso be used for drug implant extractionor to perform vein biopsies (45,46). Pa-tients, or their representatives, must beable to give informed consent and be ingood health with normal cardiovascular

Table 4Indications and Contraindications

IndicationsAsymptomatic varicose veins for

cosmetic purposesSymptomatic varicose veinsComplications of varicose veins

Superficial thrombophlebitisRecurrent thrombophlebitisBleeding

ContraindicationsAbsolute

Infectious dermatitis or cellulitis inarea to be treated

Severe peripheral edemaSeriously ill patientsPatients not able to follow

postoperative instructionsAllergies to local anesthetics

RelativePregnant or nursing patientsObstructed deep venous systemLiver dysfunctionSevere uncorrectable coagulopathy

or hypercoagulable statesInability to wear compression

stockingsInability to ambulate

and pulmonary status (Table 4).


Contraindications for AP

Absolute contraindications for AP in-clude infectious dermatitis or cellulitisin the area to be treated, severe periph-eral edema, lymphedema, serious ill-ness, inability to follow postoperativeinstructions, and allergies to local anes-thetic agents (22,41–43). Relative contra-indications include patients who arepregnant or nursing, have a obstructeddeep venous system (ie, relying on su-perficial venous system for venousdrainage), liver dysfunction (ie, limitingmetabolism of local anesthetic agent),severe uncorrectable coagulopathy orhypercoagulable states, inability to wearcompression stocking secondary to in-adequate arterial circulation, or hyper-sensitivity to compression stockings andinability to ambulate after the procedure(Table 4).

Treatment Guidelines for AP

Treatment of proximal to distalCVD is of critical importance for goodpatient outcomes and to limit recur-rence and appearance of new veins.After a proper clinical evaluation, anyGSV or SSV reflux must first be treatedwith EVTA, sclerotherapy, or high li-gation and/or stripping. AP may beperformed concurrently or after treat-ment of proximal venous disease.

AP may be performed in an outpa-tient office or hospital setting. The fa-cility should be equipped with goodlighting and resuscitation capabilities,including medications to treat allergicreactions and volume replacementagents in case of excessive blood loss.A procedure table capable of Tren-delenburg position may be helpful inperforming the procedure. The proce-dure is typically performed under lo-cal anesthesia and no premedication isusually given. Before starting the pro-cedure, the patient is placed in astanding position, preferably on aplatform for the comfort of the practi-tioner. Photographs can be taken ofthe area to be treated for documenta-tion of the pretreatment appearance.In the standing position, the veins tobe treated with AP can be marked outwith a surgical pen or permanentmarker. The marking should ideallybe done by the physician performingthe procedure.

The patient should then be placed
in a supine or prone position on the
procedure table. With the patient in arecumbent position, there is typicallycontraction and change in position ofthe vein(s) to be treated. Transillumi-nation can be used to again locate thevein to be treated. Once the vein to betreated is localized with light guid-ance, a second set of markings using adifferent color surgical pen or markershould be placed directly on the vein(47–53). The area to be treated shouldthen be prepared in a sterile fashion.Tumescent anesthesia should then beinstilled around the vein to permitvein extraction and limit patient dis-comfort. Tumescent mixtures withconcentrations from 0.01% to 0.1% li-docaine may be used. The amount oflocal anesthetic agent used should fol-low the usual recommendations ac-cording to the patient’s body weight.Up to 5 mg of lidocaine per kilogramof body weight can be administered. Ifepinephrine is added, up to 7 mg/kgof lidocaine can be administered. If theamount of local anesthesia to be usedis more than the recommended maxi-mum dose, then the procedure shouldbe staged and divided into multiplesessions. The interval between ses-sions is at the discretion of the physi-cian and patient. Epinephrine may beused for most procedures. The poten-tial advantage of epinephrine is con-traction of superficial veins possiblydecreasing the amount of bleeding af-ter AP. The potential risks associatedwith epinephrine include skin necrosisand tachycardia. If the patient’s age isgreater than 60 years, lidocaine with-out epinephrine may be used to pre-vent cardiac complications. Sodiumbicarbonate may be used to buffer thetumescent solution and make the infil-tration less painful (22,41,54–58).

Cutaneous microincisions are per-formed with an 18-gauge needle,number 11 blade grasped transverselywith a needle holder, or ophthalmicscalpels. The size of the microincisionsvaries between 1 mm and 3 mm inlength. A longer microincision leads toa more visible scar and a greater pos-sibility of scar formation or pigmenta-tion. In the thigh, lower leg, and foot,the microincisions may be performedvertically for a potentially better cos-metic result. Around the knee, the ten-sion lines can be followed. The inter-val between the microincisions canvary from 1 cm to 5 cm, depending on
size, length, and types of veins ex-
tracted. Most microincisions may beleft alone without any sutures or tapeplaced on them. An alternative is toplace gauze on the microincisions witha long stretch bandage on top. Tape oradhesive bandages applied on micro-incisions may lead to blistering, aller-gic dermatitis, or pigmentation. Whenthe microincisions are longer than 3mm, a single 6–0 nylon suture can beapplied to obtain a better closure.

There are several types of hooks thathave been exclusively designed for AP.The hooks differ in their sharpness andshape of the tip. Common hooks usedinclude the Muller hooks and Ramalethooks (3–8). There are many new gen-erations of hooks being created. Com-mercial over-the-counter hooks areavailable for AP, but care must be usedduring use. Once the hook is introducedthrough the microincision, it should berotated and moved in a perpendicularplane against the vein to be removed. Ifthere is difficulty introducing the hook,a blunt dissector may be introducedthrough the microincision to free theperivenous adventitial tissues. Once thevein is hooked, it should be brought tothe skin surface gently through the mi-croincision and grasped with a mos-quito clamp. With a gentle rotating mo-tion, the vein should be loosened fromthe perivenous adventitial tissues andslowly avulsed. Very gentle tractionshould be applied with a mosquitoclamp as the vein is removed. Tractionon the mosquito clamp allows removalof the vein and also outlines the courseof the vein. As the segment of vein be-comes larger and longer with gentletraction, the mosquito clamp should berepositioned closer to the skin surface todecrease the tensile force on the vein. Itis an option to divide the vein betweenthe mosquito clamps. It is important tonote that the mosquito clamp shouldnever be introduced into the microinci-sion. It is recommended that the tip ofthe mosquito clamp be pointed upwardas it is either pulled or rolled over thevein in the same or in a counter direc-tion while traction is applied. It is im-portant that the physician try to removethe entire segment of the vein that hasbeen marked. Retained segments of var-icose veins will develop superficialthrombophlebitis, leading to indurationand bruising and leaving hard, tender,or lumpy areas for prolonged periods of
time. These areas will have a tendency


to leave dark pigmentation in the over-lying skin. Hemostasis is achieved byintra- and postprocedural local com-pression.

AP in the ankle or foot regionshould be only performed after signif-icant experience has been obtained inother areas in the lower extremity.Special care must be paid to these ar-eas to avoid neurovascular injury. Thehooking technique should be muchmore gentle and deliberate than inother areas in the lower extremity. Thefoot should be dorsiflexed to decreasetension of the anatomic structures. Af-ter the vein is hooked it should comeout easily. If the patient experiencespain or removal of the vein requires alarge amount of tension, it is a strongpossibility that a different structuresuch as a nerve or tendon has beenhooked. The hook should then be re-moved and reinserted and another at-tempt made. Aggressive insertion ofthe hook into the microincision and“hooking” of structures should beavoided to prevent complications. APin the pretibial area must be per-formed with caution because the largenumber of lymphatic vessels locatedin this area. AP in the popliteal fossashould also be performed with greatcare as the skin behind the knee isquite thin and microincisions are eas-ily enlarged by aggressive hooking.Any additional tissue extruded frommicroincision sites should be rein-serted (59–65).

POSTTREATMENT CARE

After AP is completed, the legtreated should be cleaned. The appli-cation of antiseptic powder or solutionshould be avoided, as it may inducesilicotic granulomas (66). Adequatedressing of the area treated is a criticalstep in the follow-up care. The micro-incisions should be covered with ster-ile gauze or absorbent (ie, nonadhe-sive) pads and then with a highelasticity (ie, long-stretch) bandage.This achieves compression across thetreated area, preventing postproce-dural hemorrhage, pain, and othercomplications. The bandage should beapplied distally too proximally tocover the treated area (67,68). Tape oradhesive bandages should not be ap-plied on the microincisions because of
the risk of blistering, allergic dermati-
tis, or pigmentation. A class II closed-toe graduated compression stockingbased on the site of treatment shouldbe worn over the dressing to applyextra pressure and keep the dressingsin place. The sterile gauze or absorbentpads should be removed between 2 to7 days after the procedure based onthe size and location of the veins thathave been removed. The compressionstocking should be left on for a periodof 2–4 weeks depending on theamount of bruising after the gauzeand institution treatment protocol,and until absorbent pads have beenremoved (18,22,41).

Patients should be instructed towalk around the office for a minimumof 30 minutes after the procedure, toensure there is no postproceduralbleeding and that the dressings andstockings are comfortable and tolera-ble for the patient. After the initial am-bulation, patients can be discharged.Patients should be instructed not todrive home as the tumescent anesthe-sia may have lingering effects on themotor nerves. Patients should be en-couraged to ambulate as much as pos-sible at home. More vigorous exerciseis generally discouraged for the firstweek to avoid developing increasedcentral venous pressure on the treatedarea. Long periods of immobility suchas those that occur with air flights orlong car rides soon after AP should bediscouraged to minimize venous stasisand the risk of DVT. Pain control maybe achieved using an over-the-countermedication such as ibuprofen or, if alarge segment of vein has been re-moved, acetaminophen (300 mg) withcodeine phosphate (30 mg) and caf-feine (15 mg) may be prescribed.

Patients should return to the officeafter 4–7 days or as per institution pro-tocol to have the dressings removed andthe microincisions checked. After thedressings are removed, patients shouldcontinue to wear the compression stock-ings for a total of 2–4 weeks dependingon the amount of bruising. Patientsshould return for further follow-up ap-pointments at approximately 4 –12weeks. At each follow-up appointment,the microincisions should be checkedfor healing. Residual reticular veins ortelangiectasias may be treated with scle-rotherapy at the operator’s discretion
(7,22,41,60,62).
SUCCESS RATES

Clinical success, as described in thesection on treatment methods, is de-fined as an improvement in the clinicalstatus of a patient as defined by one ofthe objective assessment instruments,such as the CEAP or VCSS classifica-tion, by at least one grade. Setting anappropriate success rate threshold forAP is difficult. There are many vari-ables that will affect the eventual suc-cess of the procedure. These includepatient population, type of CVDtreated, anatomica location of treat-ments, the experience of the physician,preprocedural assessment, and post-procedural care. There are no refer-ences in the literature suggesting ap-propriate thresholds. However, basedon anecdotal evidence there is a suc-cess rate in the range of 75%–95%(58,70).

COMPLICATIONS

Complications secondary to AP maybe classified as cutaneous, vascular, lo-cal anesthesia–related, or neurologic.Complications may be secondary to in-correct patient indications, postopera-tive dressings, or surgical technique.Many complications can be avoided asthe operating physician’s skill and expe-rience develops. However, it should benoted that complications may still occurwith perfect surgical technique. Majorcomplications are very rare. The vastmajority of complications are minorin nature as per the SIR classificationof complications (Appendix B). Thedifferent types of complications sec-ondary to AP are listed in Table 5(4,5,18,20,21,23,24,54,57,70 –74).

Cutaneous Complications

A number of different types of skinlesions may occur after AP. Most can beprevented by proper application ofpostoperative dressings. Blisters occursecondary to skin shearing (eg, withSteri-Strips or adhesive bandages) andmay lead to postbullous hypopigmenta-tion (transient or permanent) or tran-sient hyperpigmentation. Blister forma-tion may be prevented by avoiding theuse of adhesive dressings and usinggauze dressings with a short- or long-stretch bandage. Transient hyperpig-
mentation may result from hemosiderin

N


staining (after hematoma resorption)and postinflammatory melanocytic hy-peractivity. Hyperpigmentation mostcommonly fades in weeks to monthswithout treatment. However, sun pro-tection (ie, sunblock and skin coverings)and UV avoidance are critical to avoidmelanogenesis in treatment areas. Con-tact dermatitis is very rare because ofthe new generation of hypoallergenictopical medications and dressings. Visi-ble scarring after AP is rare and can beavoided with tiny incisions, minimizingskin trauma. Scarring tends to persistlonger in the younger patient popu-lation, and they should be madeaware of this before AP. Keloid for-mation is also very rare even in pa-tients at risk, most likely secondaryto the small size of the incisions. Hy-pertrophic scars are also unusualand mainly observed in the dorsumof the foot, where they fade veryslowly. Tattooing with a markingpen is rare and can be prevented byavoiding performing incisions overareas marked with a marking pen.Skin necrosis is also very rare andhas been reported after the use of 1%lidocaine with 1/100,000 epineph-rine. Therefore it is recommended1/400,000 epinephrine be used (56).Foreign body granulomas along theincision sites are no longer observed,with the elimination of postproce-dural application of antiseptic pow-

Table 5Complications Seen after AP

Common

CutaneousTransient pigmentationSkin blisters

VascularHematomas

Local anestheticNeurologic

der (8,66,75).

Vascular Complications

The incidence of vascular complica-tions is correlated with the size and typeof treated vessels (more likely with per-forator veins) and location of AP (morecommon in thigh and popliteal fold), orthe patient’s history (previous sclero-therapy, phlebitis, lipodermatosclero-sis). Appropriate compression anddressing should reduce the incidenceand hopefully avoid such complica-tions.

Postprocedural bleeding from themicroincision sites may occur whenthe patient stands up or after someminutes of walking after undergoingthe procedure. This type of bleedingcan be controlled by additional pres-sure with gauze pads and reinforce-ment of the pressure dressing. There-fore it is advisable to reassess thedressing after 30 minutes of ambula-tion. Postprocedural bleeding occursmore frequently with perforator avul-sion and in patients with postthrom-botic syndrome. Careful and pro-longed compression of the incisionafter removal of perforator vein is rec-ommended.

Diffuse postprocedural hematomasare frequently seen, depending on thefragility of the patient’s skin and effec-tiveness of the compression. Theseare typically self-limited. Superficialthrombophlebitis of incompletely re-

Rare

ontact dermatitisnfectioneloidsattooing with marking penoreign body (silicotic) granulomaecrobiosis lipoidica

ostoperative hemorrhageatting (neovascularity)

uperficial phlebitisVTdemaymphatic pseudocystoncomitant anesthesia of deeper nervesostoperative painarpotarsal syndromeransitory or permanent sensory deficiteuroma

moved varicose veins or in the neigh-

boring vein may occur some days afterAP. Conservative measures includingcompression or oral antiinflammatorydrugs, or invasive therapy such asevacuation of the clots and AP of theinflamed vein followed by compres-sion and ambulation, will help relievethe symptoms.

DVT has rarely been reported afterAP. This would be considered a majorcomplication per SIR criteria and treat-ment would include anticoagulationalong with compression (18). Edema ismost commonly the result of an incor-rectly applied dressing and will resolveafter one night without the compressionbandage. Edema may persist for severalmonths after AP of the foot or SSV, as aresult of unrecognized lymphatic insuf-ficiency (76). Lymphocele is a rare com-plication of AP of the ankle, pretibial orpopliteal areas with rapid developmentof a soft, painless fluctuant nodule. Thismay be punctured and drained. Alter-natively compression with circular mas-sage may be helpful. Neovascularity or“matting” is a complication of AP, scle-rotherapy, and surgical ligation andstripping. The cause is unknown, andthe matting may resolve spontaneouslyor be treated with sclerotherapy after a3-month interval.

Local Anesthetic Complications

Anaphylactic reactions to local anes-thetic agents are very rare. Toxic reac-tions may occur after accidental intra-vascular injection or use of concentratedsolutions or in individually sensitive pa-tients. Infiltration of the local anestheticagent must be stopped if signs such asmalaise, tremor, or paresthesias occur.Rarely, tumescent anesthesia may pene-trate more deeply, particularly in thepopliteal fold area, leading to infiltrationof motor fibers of the peroneal nerveand causing transient nerve palsies suchas drop foot, which clears within severalhours. It is important to test the mobilityof the foot before the patient stands up.

Neurologic Complications

Neurologic symptoms may be ariseas a result of the compressive dressingapplication and can be relieved with re-moval and reapplication of the dressing.Intraprocedure manipulation of a nerveis very painful and may cause transientpostprocedural paresthesias. If a patient

CIKTFN

PMSDELCPCT

describes pain on insertion of the AP


hook or upon exteriorization of “vein,”the structure should be released and theAP hook reinserted to prevent nervedamage. If nerve injuries are observed,they typically occur in AP of the SSV asthe sural nerve may be damaged by thehook, leading to paresthesia, ortransected with permanent completesensory loss over a large cutaneous area.

Published rates for individual typesof complications are highly dependenton patient selection and are based onseries comprising several hundred pa-tients, which is a volume larger thanmost individual practitioners are likelyto treat. Generally, the complication-specific thresholds should be set higherthan the complication-specific reportedrates listed earlier. It is also recognizedthat a single complication can cause arate to cross above a complication-specific threshold when the complica-tion occurs within a small patient vol-ume (eg, early in a quality improvementprogram). In Table 6, all values weresupported by the weight of literatureevidence and panel consensus.

CONCLUSION

AP is a safe, aesthetic, and effectiveprocedure for the removal of varicoseand reticular veins in the lower ex-tremity that may be performed in ei-ther an outpatient freestanding or in-patient health setting. It is a importantancillary procedure for the interven-

Table 6Threshold and Suggested Complication

Complication

CutaneousSkin blistersTransient pigmentationVisible scarsContact dermatitisInfectionsKeloids

VascularMajor hematomasPostprocedural hemorrhageSuperficial thrombophlebitisNeovascularity or mattingLymphocelePersistent edemaDVT

NeurologicParesthesiaTransient nerve palsies

tional physician in the treatment of

CVD. Thorough training and carefultechnique are essential for producingoptimal results and preventing com-plications.

Acknowledgments: Sanjoy Kundu, MD,FRCPC, authored the first draft of this doc-ument and served as topic leader duringthe subsequent revisions of the draft.Clement J. Grassi, MD, is chair of the SIRStandards of Practice Committee. John F.Cardella, MD, is Councilor of the SIR Stan-dards Division. Other members of theStandards of Practice Committee and SIRwho participated in the development ofthis clinical practice guideline are as fol-lows: John “Fritz” Angle, MD, Ganesh An-namalai, MD, Stephen Balter, PhD, DanielB. Brown, MD, Danny Chan, MD, TimothyW.I. Clark, MD, MSc, Bairbre L. Connolly,MD, Horacio D’Agostino, MD, Brian D.Davison, MD, Peter Drescher, MD, DebraAnn Gervais, MD, S. Nahum Goldberg,MD, Manraj K.S. Heran, MD, Maxim Itkin,MD, Patrick C. Malloy, MD, Tim McSorley,BS, RN, CRN, Donald L. Miller, MD, PhilipM. Meyers, MD, Robert B. Osnis, MD, Dar-ren Postoak, MD, Dheeraj K. Rajan, MD,Anne C. Roberts, MD, Steven C. Rose, MD,Tarun Sabharwal, MD, Cindy Kaiser Saiter,NP, Marc S. Schwartzberg, MD, Nasir H.Siddiqu, MD, Timothy L. Swan, MD, Patri-cia E. Thorpe, MD, Richard Towbin, MD,Aradhana Venkatesan, MD, Louis K. Wag-ner, PhD, Bret N. Wiechmann, MD, JoanWojak, MD, Curtis W. Bakal, MD, John F.Cardella, MD, Curtis A. Lewis, MD, MBA,JD, Kenneth S. Rholl, MD, David Sacks,MD, Thierry de Baere, MD, Laura Crocetti,

tes for AP

Reported (%) Suggested (%)

1–20 101–18 153–5 71–3 3

0.5–2 20.5–1 1

0.1–2.5 30.3–4.3 40.1–3 31.3–9.5 100.1–2.5 30.1–1.3 1.50.5 0.5

0.2–4.6 50–4 5

MD, and Alexis Kelekis, MD.

APPENDIX A: CONSENSUSMETHODOLOGY

Reported complication-specific ratesin some cases reflect the aggregate ofmajor and minor complications. Thresh-olds are derived from critical evaluationof the literature, evaluation of empiricaldata from Standards of Practice Com-mittee members’ practices, and, whenavailable, the SIR HI-IQ System nationaldatabase.

APPENDIX B: SOCIETY OFINTERVENTIONALRADIOLOGY STANDARDS OFPRACTICE COMMITTEECLASSIFICATION OFCOMPLICATIONS BYOUTCOME

Minor Complications

A. No therapy, no consequenceB. Nominal therapy, no conse-

quence; includes overnight admission(up to 23 hours) for observation only.

Major Complications

C. Require therapy, minor hospital-ization (� or � to 24 hrs, but �48hours).

D. Require major therapy, un-planned increase in level of care, pro-longed hospitalization (�48 hours).

E. Permanent adverse sequelaeF. Death.

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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.

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