TreatmentTreatment ofof SevereSevere VaricoseVaricose Veins:Veins: SurgerySurgery vs.vs. MedicalMedical Therapy.Therapy.

SurgicalSurgical ArgumentArgument

John C. Eun, M.D. University of Colorado Health Sciences Center Grand Rounds Presentation 3/19/07 DefinitionDefinition

VaricoseVaricose VeinsVeins——PermanentPermanent dilatationdilatation andand tortuositytortuosity ofof aa vein.vein.

*Stedman’s Concise Medical Dictionary

http://www.dornier.com PrevalencePrevalence 2, 17

„ OneOne ofof thethe mostmost prevalentprevalent medicalmedical disordersdisorders inin thethe U.S.U.S. •• AlmostAlmost 4040 millionmillion peoplepeople •• PrevalencePrevalence closeclose toto DiabetesDiabetes inin westernwestern countriescountries SymptomsSymptoms

„ MostMost areare AsymptomaticAsymptomatic

„ DispleasureDispleasure ofof CosmeticCosmetic AppearanceAppearance

„ Tiredness,Tiredness, HeavinessHeaviness ofof legleg

„ DullDull aching,aching, BurningBurning painpain •• WorseWorse withwith standingstanding oror withwith hothot weatherweather ComplicationsComplications 2, 17, 21, 22

„ RecurrentRecurrent SuperficialSuperficial ThrombophlebitisThrombophlebitis (20(20--50%)50%) „ CellulitisCellulitis „ DVTDVT 3x3x moremore likelylikely inin peoplepeople withwith VaricoseVaricose VeinsVeins „ Hemorrhage/BleedingHemorrhage/Bleeding fromfrom traumatizedtraumatized varicositiesvaricosities „ VaricoseVaricose EczemaEczema • Extravasation of RBC’s, and breakdown in the skin RiskRisk FactorsFactors 2, 17

„ Sex „ Aging • Incidence in women/men in 5th decade of life approx. 41%/24% and increases to 72%/43% by the 7th decade „ Tall stature „ Obesity „ Standing for long periods of time „ Restrictive clothing „ Marfan’s Syndrome „ Ehlers-Danlos Syndrome „ Family History „ Pregnancy „ OCP’s ClassificationClassification

„ C,C, E,E, A,A, PP ClassificationClassification ofof ChronicChronic LowerLower ExtremityExtremity VenousVenous Disease.Disease. ClassificationClassification

2 „ C: Clinical Signs • Class 0: No visible/palpable signs of venous disease • Class 1: Telangiectasias, reticular veins, malleolar flare • Class 2: Varicose Veins • Class 3: Edema w/o skin changes • Class 4: Skin changes ascribed to venous disease (pigmentation, venous eczema) • Class 5: Skin changes defined above with healed ulceration • Class 6: Skin changes defined above with active ulceration

„ --Moderate to advance CVI is class 3-6 ClassificationClassification

2 „ E:E: EtiologicEtiologic •• CongenitalCongenital •• PrimaryPrimary——defectdefect isis thethe absenceabsence oror incompetenceincompetence ofof thethe saphenofemoralsaphenofemoral valvevalve andand otherother valvesvalves inin thethe greatergreater andand lesserlesser saphenoussaphenous systemsystem •• SecondarySecondary——occuroccur asas aa resultresult ofof traumatrauma oror phlebitisphlebitis oror thethe venousvenous systemssystems thatthat hashas damageddamaged thethe valvularvalvular systemsystem ClassificationClassification

2 „ A:A: AnatomicAnatomic DistributionDistribution •• SuperficialSuperficial •• DeepDeep •• PerforatorPerforator •• AloneAlone oror inin anyany combinationcombination ofof aboveabove ClassificationClassification

2 „ P:P: PathophysiologicPathophysiologic DysfunctionDysfunction •• RefluxReflux •• ObstructionObstruction •• AloneAlone oror inin combinationcombination AnatomyAnatomy

Greater Saphenous Vein (GSV) begins anterior to the medial malleolus and rises obliquely and posterior as it crosses the anteromedial surface of the tibia. At the knee joint—joined by http://healthlibrary.epnet.com the posterior arch vein. The GSV rides

on top f the fascia to http://healthlibrary.epnet.com join common femoral vein at the foramen ovale. 17 AnatomyAnatomy

Lesser Saphenous Vein (LSV): Begins posterior to the lateral malleolus and courses upward. In the middle third of the calf it turns midline and enters the deep fascia in the upper third of the calf. In 60% of pts., the LSV enters the popliteal vein

directly. The http://healthlibrary.epnet.com remainder joins the GSV at the knee level. 17GSV at the knee level. AnatomyAnatomy

http://www.richmondveincenter.com PathogenesisPathogenesis

„ InIn healthyhealthy veins:veins: •• OneOne--wayway valvesvalves directdirect flowflow ofof venousvenous bloodblood fromfrom thethe superficialsuperficial venousvenous capillariescapillaries ÆÆ largerlarger superficialsuperficial veinsveins ÆÆ deepdeep veinsveins ÆÆ IVCIVC ÆÆ heart.heart.

•• PerforatingPerforating VeinsVeins allowallow bloodblood toto movemove fromfrom thethe superficialsuperficial venousvenous systemsystem toto thethe deepdeep venousvenous system.system. PathogenesisPathogenesis

• In the muscle compartments of the leg and thigh, blood is pushed upward through the one-way valves of the veins. Pressures can be as high at 5 atm’s.—the fascia surrounding the deep

veins prevent excessive http://www.richmondveincenter.com dilatation. 22 PathogenesisPathogenesis

„ Superficial veins normally encounter pressures that are much lower than the deep system, and exposure to persistently high pressures ccanan cause dilatation and create varicosities.22 • Most valve failure is secondary to elevated pressures—with continued exposure of elevated http//www.veininnovations.com venous pressure, the veins dilate so much that their valve leaflets no longer meet. PathogenesisPathogenesis

„ WhenWhen aa singlesingle venousvenous valvevalve fails,fails, itit createscreates aa locallocal highhigh pressurepressure areaarea andand locallocal dilatationdilatation •• whichwhich thenthen leadsleads toto adjacentadjacent valvevalve failurefailure andand moremore regionalregional dilatationdilatation ofof thethe veinvein ““aa recruitmentrecruitment phenomenonphenomenon””22 PathogenesisPathogenesis 21,21, 2222

„ Women:Women: veinvein wallswalls andand valvesvalves periodicallyperiodically becomebecome moremore distensibledistensible withwith thethe cycliccyclic increasesincreases inin progesterone.progesterone. • Pregnancy increases this susceptibility due to the hormonal changes that lead to increased distensibility of vein walls and soften valve leaflets „ Also increase in blood volume. „ Later in pregnancy—gravid uterus presses on IVC- causing further venous pressures. „ Varicose veins of pregnancy may or may not go away after delivery. DiagnosisDiagnosis

22 „ PhysicalPhysical ExamExam :: •• ArrangedArranged inin anan organizedorganized mannermanner

„ Distal to proximal, front to back • May find cutaneous ulceration, telangiectasias, eczema, brown spots, prominent varicose veins. • Healthy veins are typically only visibly distended at the foot and ankle—distension at other levels usually imply venous disease. • Darkened, discolored, stained skin are usually signs of chronic venous stasis. DiagnosisDiagnosis

22 „ PalpationPalpation :: dilateddilated veinsveins maymay bebe palpablepalpable eveneven ifif notnot visible.visible. •• newnew varicesvarices sitsit onon thethe surfacesurface ofof musclemuscle oror bone.bone. •• chronicchronic varicesvarices erodeerode intointo thethe underlyingunderlying musclemuscle oror bonebone makingmaking themthem feelfeel ““boggyboggy”” oror ““spongyspongy””.. DiagnosisDiagnosis

22 „ PerthesPerthes ManeuverManeuver •• AA testtest designeddesigned toto distinguishdistinguish antegradeantegrade flowflow fromfrom retrograderetrograde flowflow inin superficialsuperficial varices.varices. •• AntegradeAntegrade flowflow indicatesindicates thatthat thethe systemsystem isis aa bypassbypass pathwaypathway aroundaround aa deepdeep veinvein obstructionobstruction andand shouldshould notnot bebe ablatedablated DiagnosisDiagnosis22

„ PlacePlace aa tourniquettourniquet overover thethe proximalproximal partpart ofof thethe varicosevaricose leg.leg. HaveHave thethe patientpatient walkwalk oror dodo toetoe--standsstands toto activateactivate thethe calfcalf--musclemuscle pump.pump. „ TheThe musclemuscle pumppump normallynormally causescauses varicosevaricose veinsveins toto bebe emptiedemptied •• butbut ifif deepdeep systemsystem obstructionobstruction exists,exists, thenthen activatingactivating thethe calfcalf--musclemuscle pumppump causescauses paradoxicalparadoxical increaseincrease inin thethe inin thethe sizesize ofof thethe varicosevaricose vein.vein. DiagnosisDiagnosis

17 „ TrendelenburgTrendelenburg TestTest :: „ DistinguishDistinguish patientspatients withwith superficialsuperficial venousvenous refluxreflux fromfrom thosethose withwith incompetentincompetent deepdeep venousvenous valves.valves. „ PlacePlace patientpatient inin supinesupine positionposition andand elevateelevate thethe legleg toto draindrain thethe bloodblood——aa tourniquettourniquet isis thenthen appliedapplied toto thethe leg.leg. „ ResultsResults basedbased onon thethe biphasicbiphasic responseresponse afterafter thethe patientspatients stands.stands. DiagnosisDiagnosis17

„ FirstFirst responseresponse tellstells ofof thethe competencycompetency ofof thethe perforatorperforator veinsveins valvesvalves ofof thethe lowerlower legleg

„ TheThe secondsecond responseresponse tellstells ofof thethe competencycompetency ofof thethe saphenofemoralsaphenofemoral valvevalve afterafter thethe tourniquettourniquet isis removed.removed. DiagnosisDiagnosis17

• Negative-Negative: Normal response— saphenofemoral valve is intact and perforating veins are intact • Negative-Positive: Incompetent saphenofemoral valve, but competent perforators • Positive-Negative: Competent saphenofemoral valve, but incompetent perforators • Positive-Positive: Incompetent saphenofemoral valve and perforators. DiagnosisDiagnosis

„ Duplex Ultrasound: gold-standard for assessing venous competence, and allows measurement of flow through valves and identification of the sources of venous reflux.

„ Doppler—probe at 45 degree angle to skin. Compression of the vein causes forward flow and gives an audible cue. When pressure is released, backward flow can also be heard. Competent valves should not have backward flow and thus no sound should be heard wwhenhen pressure is released.

„ Plethysmography: provides an indirect measurement of venous obstruction—readily available in most settings. • compares the systolic blood pressure of the lower to upper extremity, to help rule out disease that blocks the arteries in the extremities. DifferentialDifferential DiagnosisDiagnosis2121

„ IntermittentIntermittent ClaudicationClaudication

„ DeepDeep VeinVein ThrombosisThrombosis

„ NerveNerve RootRoot CompressionCompression MedicalMedical TreatmentsTreatments 21,21, 2222

„ Life-Style changes • Weight loss • Wear less constrictive clothing • Be on feet less • Elevate lower extremities „ Compression Stocking „ Sclerotherapy • Causes inflammation of the vein’s intima and thrombus formation—development of fibrous tissue and obliteration of vein • Sodium Tetradecyl (DIC, DVT) • Morrhuate Sodium (PE, Valvular incompetency, vascular collapse, thrombosis) „ Injection site reactions, perpermanentmanent discoloration at injection site, extravasation, Hypersensitivity Reactions „ Radiofrequency/Laser Obliteration RadiofrequencyRadiofrequency AblationAblation ofof thethe SaphenousSaphenous VeinVein

„ Use of Radiofrequency (RF) energy-mediated heating of the vein wall to destroy the intima and denature collagen in the media with resulting fibrous occlusion of the vein • Laser energy can also be used

http://vnus_closure_procedure.com SurgicalSurgical TreatmentsTreatments

„ VeinVein StrippingStripping

„ AmbulatoryAmbulatory PhlebectomyPhlebectomy (Removal(Removal ofof BranchBranch Varicosities)Varicosities)

„ EndoscopicEndoscopic ((TriVexTriVex))

„ SubfascialSubfascial EndoscopicEndoscopic PerforatorPerforator VeinVein SurgerySurgery IndicationsIndications forfor SurgerySurgery

„ DependentDependent on:on: •• SymptomsSymptoms •• ClinicalClinical StageStage •• PtPt’’ss willingnesswillingness toto makemake lifestylelifestyle changeschanges •• CosmeticCosmetic reasonsreasons alonealone IndicationsIndications forfor SurgerySurgery

*Cameron VeinVein StrippingStripping2121

„ RemovalRemoval ofof thethe varicosevaricose veinvein inin thethe OROR withwith multiplemultiple incisions.incisions.

„ HighHigh LigationLigation andand StrippingStripping ofof thethe GSVGSV •• ““GoldGold StandardStandard”” ofof invasiveinvasive procedures.procedures. VeinVein StrippingStripping2121

„ PerformedPerformed throughthrough aa short,short, obliqueoblique incisionincision atat thethe groingroin creasecrease——startingstarting justjust medialmedial toto thethe femoralfemoral pulsepulse andand extendingextending mediallymedially forfor 22--33 cm.cm.

„ SaphenofemoralSaphenofemoral junctiojunctionn isis locatedlocated andand allall tributariestributaries areare ligatedligated andand divided.divided. VeinVein StrippingStripping2121 „ Trunk of the GSV is dissected and then a flexible, disposable (Codman) vein stripper is introduced into the cut end of the vein at the groin and passed through the GSV to a 1 cm incision at the medial aspect of the popliteal space.

„ Vein in the groin is then ligated around the stripper with nonabsorbable suture.

„ Stripper is then inverted into the GSV and the vein is stripped from above downwards—the inverted vein come out of the knee incision and is ligated there. VeinVein StrippingStripping2121

ƒƒ HighHigh LigationLigation andand StrippingStripping ofof thethe LesserLesser SaphenousSaphenous VeinVein

ƒ Performed in the same manner as the GSV procedure but with more anatomical variation—prudent to use US to mark the saphenopopliteal junction pre-op. VeinVein StrippingStripping

4 „ Risks : • Damage to the saphenous nerve—resulting sx in up to 47% of patients. „ Approx 7% of patients have sx that affect their quality of life „ Recurrence

4 „ Benefits : • Complete removal of varicosity decreases recurrence rates. • Relieves leg pain • Improves cosmetic appearance. • Prevents complications of venous stasis—skin/pigment changes, ulcers, etc… AmbulatoryAmbulatory PhlebectomyPhlebectomy2727

„ AmbulatoryAmbulatory phlebectomyphlebectomy isis indicatedindicated forfor diseasedisease notnot atat thethe saphenofemoralsaphenofemoral andand saphenopoplitealsaphenopopliteal junctions.junctions. •• BranchBranch varicositiesvaricosities ofof thethe greatergreater saphenoussaphenous veinvein •• PudendalPudendal veinsveins inin thethe groingroin •• ReticularReticular varicesvarices inin thethe poplitealpopliteal foldfold oror laterallateral partpart ofof thethe thigh.thigh. AmbulatoryAmbulatory PhlebectomyPhlebectomy (Removal(Removal ofof BranchBranch Varicosities)Varicosities)2121

„ Removal of varicose veins through small (1-2 mm) incisions in the skin

„ Vein clusters are marked pre-operatively with the patient in the standing position

„ Incision usually done vertically to minimize lymphatic channel, except at the knee or ankle where the incision is transverse at the skin crease

http://treatveins.com AmbulatoryAmbulatory PhlebectomyPhlebectomy2121

„ Varicosity is grasped wwithith a crochet or hook—pulled out of the incision and grasped with a clamp. „ As much of the varicosity is then pulled out of the incision. „ Ligation of the ends of the veins not necessary— hemostasis is achieved by http://www.dermatologytimes.com limb elevation and local pressure. „ Incisions are closed wwithith steri-strips. AmbulatoryAmbulatory PhlebectomyPhlebectomy2121

„ Risks: • Bleeding • Hematoma • Sensory Nerve Damage • Chronic Foot Edema

„ Benefits: can be performed in an outpatient setting. • Wounds leave very little, if any, scarring.

„ Considerations: • Need to wear compressions garments after surgery • Does not prevent recurrence TriVexTriVex2626

„ Uses 2-3 incisions st „ 1 instrument illuminates the varicose vein through the skin using fiber optics nd „ 2 instrument is a vein resector that is guided next to the vein underneath the skin. Suction draws the vein into the tip of the vein resector where a rotating blade effectively removes the leg vein. http://endo.smith-nephew.com TriVexTriVex

http://endo.smith-nephew.com SubfascialSubfascial EndoscopicEndoscopic PerforatorPerforator VeinVein SurgerySurgery (SEPS)(SEPS) 2121

„ PerforatingPerforating veinsveins inin thethe calfcalf connectconnect thethe superficialsuperficial toto thethe deepdeep venousvenous systemssystems andand havehave valvesvalves thatthat provideprovide aa oneone--wayway flowflow towardstowards thethe deepdeep system.system.

„ TheThe medialmedial calfcalf perforatorsperforators——CockettCockett PerforatorsPerforators——dodo notnot originateoriginate fromfrom thethe GSVGSV • Posterior arch vein to the paired posterior tibial veins • Stripping and removal of the GSV will not affect these perforators. SubfascialSubfascial EndoscopicEndoscopic PerforatorPerforator VeinVein SurgerySurgery (SEPS)(SEPS) 21,21, 2222

„ Cockett I perforator is located posterior to the medial malleolus

„ Cockett II and III are located in the distal calf 2-4 cm posterior to the medial edge of the tibia.

„ Presence if incompetent perforator in patients with advanced CVI is an indication for perforator ligation.

Gloviczki P, Yao, JST, eds. Handbook of Venous Disorders, 2nd ed. London: Arnold, 2001:18, Fig. 2.9.) SubfascialSubfascial EndoscopicEndoscopic PerforatorPerforator VeinVein SurgerySurgery (SEPS)(SEPS) 2121

„ The “two-port” technique of SEPS is used in the U.S.: one port for the camera, and a separate ports for the instruments. „ Limb is first exsanguinated and a tourniquet is placed to provide a bloodless field. „ CO2 is insufflated into the subfascial space. „ Subfascial space is explored and all perforator encountered http://www.njsurgery.com are divided with harmonic scalpel, electrocautery, or clips. StudiesStudies

„ BelcaroBelcaro etet al,al, AngiologyAngiology JulyJuly 20002000 •• EvaluatedEvaluated SclerotherapySclerotherapy vs.vs. SurgerySurgery vs.vs. SurgerySurgery withwith SclerotherapySclerotherapy

„ Randomized Control Trial with 10-year follow-up BelcaroBelcaro 20002000

„ GroupGroup A:A: 3939——SclerotherapySclerotherapy alone.alone.

„ GroupGroup B:B: 4040——SurgerySurgery alone.alone.

„ GroupGroup C:C: 4242——SurgerySurgery andand Sclerotherapy.Sclerotherapy. BelcaroBelcaro 20002000

„ InclusionInclusion Criteria:Criteria: 4040--6060 withwith simplesimple superficialsuperficial venousvenous incompetenceincompetence (uncomplicated(uncomplicated byby phlebitis,phlebitis, hemorrhage,hemorrhage, oror ulcers).ulcers).

„ Excluded:Excluded: DVT,DVT, superficialsuperficial thrombophlebitis,thrombophlebitis, obesity,obesity, diabetesdiabetes otherother clinicallyclinically significantsignificant diseases,diseases, oror patientspatients previouslypreviously treatedtreated withwith surgery/sclerotherapysurgery/sclerotherapy inin thethe past.past. BelcaroBelcaro 20002000

„ IncompetenceIncompetence waswas evaluatedevaluated withwith colorcolor duplexduplex scanningscanning

„ PatientsPatients werewere thenthen evaluatedevaluated everyevery 22 yearsyears forfor 1010 yearsyears withwith colorcolor duplexduplex andand AVPAVP measurementsmeasurements BelcaroBelcaro 20002000 BelcaroBelcaro 20002000

„ AtAt oneone yearyear allall treatedtreated patientspatients werewere occluded.occluded.

„ AtAt laterlater followfollow upup (4(4--1010 years)years) 66 patientspatients becamebecame incompetentincompetent atat thethe SFJSFJ withwith SclerotherapySclerotherapy alone.alone. BelcaroBelcaro 20002000

„ Conclusion:Conclusion: •• SclerotherapySclerotherapy alonealone isis anan effectiveeffective solutionsolution toto varicosevaricose veinsveins •• ButBut inin thethe longlong termterm (10+years)(10+years) surgerysurgery isis superior.superior. •• SurgerySurgery andand SclerotherapySclerotherapy isis best.best. StudiesStudies

„ DeDe RoosRoos etet al.al. DermatologicDermatologic SurgerySurgery 2003.2003.

„ RCTRCT comparingcomparing sclerotherapysclerotherapy andand ambulatoryambulatory phlebectomy.phlebectomy. DeDe RoosRoos 20032003

„ SeptemberSeptember 19961996 toto OctoberOctober 19981998

„ 4949 patientspatients werewere randomlyrandomly assignedassigned toto compressioncompression sclerotherapysclerotherapy..

„ 4949 toto ambulatoryambulatory phlebectomy.phlebectomy.

„ DopplerDoppler UltrasoundUltrasound evaluatedevaluated GSVGSV incompetence.incompetence. DeDe RoosRoos 20032003

„ 11 yearyear later:later: •• SclerotherapySclerotherapy——12/4912/49 (25%)(25%) recurredrecurred •• SurgerySurgery——1/491/49 (2.1%)(2.1%)

„ 22 yearsyears later:later: •• SclerotherapySclerotherapy——18/4918/49 (37.5%)(37.5%) •• SurgerySurgery——1/491/49 (2.1%)(2.1%) DeDe RoosRoos 20032003

„ SurgerySurgery isis thethe treatmenttreatment ofof choicechoice forfor varicosevaricose veins.veins.

„ IfIf sclerotherapysclerotherapy isis chosen,chosen, andand isis unsuccessfulunsuccessful afterafter 22 treatments,treatments, surgerysurgery shouldshould bebe nextnext step.step. StudiesStudies

„ Rigby,Rigby, KA.KA. SurgerySurgery versusversus sclerotherapysclerotherapy forfor thethe treatmenttreatment ofof varicosevaricose veinsveins——CochraneCochrane databasedatabase Review.Review.

„ 99 RCTRCT trialstrials withwith 33133313 patientspatients inin thethe trialstrials comparingcomparing sclerotherapysclerotherapy vs.vs. surgerysurgery RigbyRigby 20072007

„ ““TradeTrade--offoff betweenbetween lowerlower costcost andand fewerfewer seriousserious complicationscomplications withwith sclerotherapysclerotherapy showingshowing betterbetter earlyearly outcomesoutcomes butbut surgicalsurgical treatmenttreatment showingshowing moremore durabledurable longlong--termterm benefits.benefits.””

„ ““TheThe exactexact lineslines betweenbetween thethe useuse ofof oneone oror thethe otherother areare unclear.unclear.”” StudiesStudies

„ Rautio,Rautio, etet al.al. EndovenousEndovenous obliterationobliteration versusversus conventionalconventional strippingstripping operationoperation inin thethe treatmenttreatment ofof primaryprimary varicosevaricose veins:veins: AA randomizedrandomized controlledcontrolled trialtrial withwith comparisoncomparison ofof thethe costs.costs. JJ VascVasc Surgery,Surgery, 2002.2002. RautioRautio 20022002

„ RandomizedRandomized intointo 22 groupsgroups •• GroupGroup 1:1: 1515——EndovenousEndovenous ClosureClosure •• GroupGroup 2:2: 1313——VeinVein strippingstripping

„ PtPt werewere evaluatedevaluated withwith colorcolor duplexduplex ultrasoundultrasound toto showshow GSVGSV reflux.reflux.

„ AfterAfter procedures,procedures, patientspatients reportedreported painpain atat rest,rest, onon standing,standing, andand walkingwalking withwith aa 00 toto 1010 scalescale RautioRautio 20022002

„ AA shortshort terntern RANDRAND--3636 genericgeneric healthhealth-- relatedrelated qualityquality ofof lifelife questionnairequestionnaire waswas givengiven atat 11 andand 44 weeksweeks postpost--op.op.

„ PatientsPatients werewere reexaminedreexamined 77 toto 88 weeksweeks postpost--opop withwith colorcolor duplexduplex US.US.

„ PatientsPatients werewere alsoalso askedasked howhow muchmuch timetime offoff waswas neededneeded andand askedasked ifif theythey werewere satisfiedsatisfied withwith thethe procedure.procedure. RautioRautio 20022002

„ CostCost waswas analyzed:analyzed: •• DirectDirect costscosts (surgery,(surgery, hospitalhospital costs,costs, etc.)etc.) •• IndirectIndirect costscosts (value(value ofof lossloss ofof productivityproductivity fromfrom work).work). RautioRautio 20022002

Closure Stripping (n=15) (n=13) Saphenous nerve Paresthesia 2 3

Clinical thrombophlebitis 3

Local hematoma 1 4

Thermal skin injury 1

Total 7 7 RautioRautio 20022002

„ PostPost--opop painpain scorescore •• RestRest „ 0.7 SD 0.5—Endovascular „ 1.7 SD 1.3—Surgery •• StandingStanding „ 1.3 SD 0.7—Endovascular „ 2.6 SD 1.9—Surgery •• WalkingWalking „ 1.8 SD 0.8—Endovascular „ 3.0 SD 1.8—Surgery RautioRautio 20022002

„ SickSick Leave:Leave: • 6.5 days SD 3.3—Endovascular • 15.6 SD 6.0--Surgery „ DirectDirect CostsCosts • $794—Endovascular • $360--Surgery „ IndirectIndirect CostsCosts (number(number ofof daysdays lostlost xx avgavg salarysalary inin FinlandFinland ++ 50%50% nonwagenonwage costs)costs) • $607—Endovascular • $1566—Surgery RautioRautio 20022002

„ TotalTotal Cost:Cost:

•• $1401$1401 forfor EndovascularEndovascular •• $1926$1926 forfor SurgerySurgery

„ Difference of $525

„ Investment of the VNUS Closure Generator $3400 plus the catheter RautioRautio 20022002

„ ConclusionConclusion •• EndovascularEndovascular easiereasier onon patientpatient’’ss postpost--opop painpain whenwhen comparedcompared toto surgery.surgery. •• MoreMore expensiveexpensive forfor thethe hospital.hospital. •• LessLess expensiveexpensive forfor societysociety inin general.general. •• RecommendRecommend longlong termterm studystudy forfor varicosevaricose veinvein recurrence.recurrence. StudiesStudies

„ Lurie,Lurie, etet al.al. ProspectiveProspective randomizedrandomized studystudy ofof endovenousendovenous radiofrequencyradiofrequency obliterationobliteration (Closure(Closure procedure)procedure) versusversus ligationligation andand strippingstripping inin aa selectedselected patientpatient populationpopulation (EVOLVeS(EVOLVeS Study).Study). JJ VascVasc SurgerySurgery 2003.2003. LurieLurie 20032003

„ 8585 patientspatients fromfrom 55 sitessites •• FranceFrance--22 •• AustriaAustria--11 •• USUS--22

„ S&LS&L group:group: 3636

„ RFORFO group:group: 4444 LurieLurie 20032003

„ FollowFollow--upup •• 72hrs72hrs •• 11 weekweek •• 33 weeksweeks •• 44 months.months.

„ PatientsPatients underwentunderwent CIVIQ2CIVIQ2 qualityquality-- ofof--lifelife questionnairequestionnaire andand ultrasoundultrasound duplexduplex scanning.scanning. LurieLurie 20032003

„ ResultsResults •• 36/3636/36 ofof S&LS&L werewere freefree ofof refluxreflux oror flowflow throughthrough thethe GSVGSV atat 7272 hrshrs

•• 36/4336/43 werewere freefree ofof flowflow atat 7272 hrshrs inin RFORFO group.group. LurieLurie 20032003

Complications were negligible at 4 months follow up. LurieLurie 20032003

„ TimeTime toto returnreturn toto normalnormal activitiesactivities •• 1.151.15 daysdays ––RFORFO •• 3.893.89 daysdays ––S&LS&L

„ ReturnReturn toto workwork •• 4.74.7 daysdays——RFORFO •• 12.412.4 daysdays——S&LS&L

„ LessLess painpain reportedreported byby RFORFO vs.vs. S&LS&L LurieLurie 20052005

„ TwoTwo yearyear followfollow--up,up, EurEur JJ EndovascEndovasc SurgSurg,, 20052005

„ RecurrenceRecurrence raterate waswas 14.3%14.3% forfor RFORFO andand 20.9%20.9% withwith S&LS&L

„ RecurrenceRecurrence raterate waswas numericallynumerically lowerlower inin thethe RFORFO groupgroup atat 22 yearsyears butbut notnot toto thethe levellevel ofof statisticalstatistical significancesignificance (CI(CI 0.70.7--28)28) StudiesStudies

„ Perala,Perala, etet al.al. RadiofrequencyRadiofrequency EndovenousEndovenous obliterationobliteration versusversus strippingstripping ofof thethe longlong saphenoussaphenous veinvein inin thethe managementmanagement ofof primaryprimary varicosevaricose veins:veins: 33--yearyear outcomeoutcome ofof aa randomizedrandomized study.study. AnnalsAnnals ofof VascularVascular SurgerySurgery 2005.2005. PeralaPerala 20052005

„ 2828 patientspatients werewere randomizedrandomized •• 1515 RFORFO groupgroup •• 1313 StrippingStripping groupgroup

„ FollowFollow upup atat 77--88 weeks,weeks, andand alsoalso atat 33--yearyear followfollow up.up. PeralaPerala 20052005

„ AtAt 33--yearyear followfollow upup •• RecurrenceRecurrence waswas detecteddetected byby surgeonsurgeon

„ 5/15 (33%) in RFO

„ 2/13 (15%) in Stripping group •• RecurrenceRecurrence waswas noticednoticed byby patientpatient

„ 4/15 (27%) in the RFO

„ 2/13 (15%) in stripping group PeralaPerala 20052005

„ ConclusionConclusion •• ““somewhatsomewhat lessless satisfactorysatisfactory resultsresults withwith radiofrequencyradiofrequency endovenousendovenous obliterationobliteration methodmethod comparedcompared toto thethe conventionalconventional strippingstripping operationoperation withwith SFJSFJ ligationligation alongalong withwith itsits tributaries.tributaries.”” ConclusionsConclusions

„ Lifestyle changes must first be offered for patients with moderate disease.

„ Surgery is the treatment of choice for severe varicose veins when compared to sclerotherapy in the long term (5-10+ years post-op)

„ When compared to RFO: • RFO more expensive for hospital. • RFO less pain post-op and quicker recovery time. • RFO may or may not have increased rate of recurrence of varicose veins when compared to surgery—more studies need to be done. ReferencesReferences

1) Stedman’s Concise Medical Dictionary. Dirckx, John. Lippincott, Williams & Wilkins, Baltimore. 2001 th 2) Cameron, John. Current Surgical Therapy-8 Edition. Mosby, 2004 rd 3) Faust, Glenn., Cohen, Jon. Vascular Surgery for the House Officer-- 3 Edition. Williams and Wilkins. 4) Lurie F, Creton D, Eklof B, et al. Prospective randomized study of endovenous radiofrequency obliteration (closure procedure) versus ligation and stripping in a selected patient population (EVOLVeS Study). J Vasc Surgy 2003; 38:207-14 5) Rigby KA, Palfreyman SJ, Beverley C, Michaels JA. Surgery versus Sclerotherapy for the Treatment of Varicose Veins. The Cochrane Database of Systematic Reviews 2004, Issue 4. 6) Belcaro, G, Nicolaides, AN, Ricci, A, et al. Endovascular Sclerotherapy, Surgery, and Surgery plus Sclerotherapy in Superficial Venous Incompetence: a randomized, 10-year follow-up trial—final results. Angiology 2000; 51:529 7) Belcaro, G, Cesarone, MR, Di Renzo, A, et al. Foam-sclerotherapy, surgery, sclerotherapy, and combined treatment for varicose veins: a 10-year, prospective, randomized, controlled, trial (VEDICO trial). Angiology 2003; 54:307 8) Michaels, JA, Campbell, WB, Brazier, JE, et al. Randomised Clinical trial, observational study and assessment of cost-effectiveness of the treatment of varicose veins (REACTIV trial). Health Technolgy Assessment 2006; 10:1 ReferencesReferences

9) De Roos KP, Nieman F, Neumann HA. Ambulatory Phlebectomy Versus Compression Sclerotherpy: Results of a Randomized Control Trial. Dermatol Surg 2003; 29:221-226 10) Rigby KA, Palfreyman SJ, Beverley C, Michaels JA. Surgery versus sclerotherapy for the treatment of varicose veins. The Cochrane Collaboration Volume (1), 2007. 11) Lurie F, Creton D, Eklof B, Kabnick LS, Kistner RL, Pichot O, Schuller-Petrovic S, Sessa, C. Prospective randomized study of endovenous radiofrequency obliteration (closure procedure) versus ligation and stripping in a selected patient population (EVOLVeS Study), J Vasc Surg. 2003 Aug;38(2):207-14. 12) Lurie F, Creton D, Eklof B, et al. Prospective randomised study of endovenous radiofrequency obliteration (closure) versus ligation and vein stripping (EVOLVeS): two-year follow-up. Eur J Vasc Endovasc Surg. 2005 Jan;29(1):67-73. 13) Rautio T, Ohinmaa A, et al. Endovenous obliteration versus conventional stripping operation in the treatment of primary caricose veins: A randomized controlled trial with comparison of the costs. J Vasc Surgery 2002;35(5):958-65 14) Perala J, Rautio T, et al. Radiofrequency Endovenous obliteration versus stripping of the long saphenous vein in the management of primary varicose veins: 3-year outcome of a randomized study. Ann Vasc Surg 2005; 19:669-672 15) Gloviczki P, Yao, JST, eds. Handbook of Venous Disorders, 2nd ed. London: Arnold, 2001:18, Fig. 2.9. 16) http://www.dornier.com rd 17) Faust G, Cohen J. Vascular Surgery for the House Officer—3 Edition. Williams and Wilkins, 1998. ReferencesReferences

18) http://healthlibrary.epnet.com 19) http://www.richmondveincenter.com 20) http//www.veininnovations.com 21) Hodgson J, Norman G, Scherger J, Murray J. Varicose Veins. First Consult, Elsevier Limited. 2007. 22) Feied C, et al. Varicose Veins. Web MD/MD consult. 2004. 23) http://www.dermatologytimes.com 24) http://treatveins.com 25) Gloviczki P, Yao, JST, eds. Handbook of Venous Disorders, 2nd ed. London: Arnold, 2001:18, Fig. 2.9.) 26) http://endo.smith-nephew.com 27) Ratner D, et al. Varicose Veins Treated with Ambulatory Phlebectomy. Web MD/MD Consult. 2006. 28) http://www.vnus_closure_procedure.com