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Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_3751_Библиотеки_им_академика_М_И_Перельмана

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A.RadiofrequencyAblationVersusEndovenousLaserAblation
B.Ultrasound-GuidedFoamSclerotherapyVersusEndothermalAblation
C."OUTLINE-END="outline-numbering-end-hereCyanoacrylateGlueVersusEndovenousLaserAblation
KeyPoints
■Refluxofthegreatsaphenousveinsistheleadingcauseofsuperficialvenousinsufficiency
inthelowerextremity.
■Edema,restlesslegs,hyperpigmentation,pain,andvenousulcersareamongthesymptoms
ofvenousreflux.
■Radiofrequencyablation,laserablation,mechanochemicalablation(MOCA),and
sclerotherapyareundertakenforclosureofrefluxingveinsnotrespondingtotraditional therapiessuchascompression.
I.Introduction
Venousinsufficiencyandvaricoseveinsareverycommon,affectingmorethan40%ofmenand70%of womenintheir60s.1Inadditiontobeingunsightly,inmanycasestheycanleadtoaching,edema,pruritis, stasis dermatitis, lipodermatosclerosis, and even ulceration.
2,3
They can affect quality of life and be
disabling.4 The leading cause of superficial venous insufficiency in the legs is great saphenous vein (GSV) reflux.5 For centuries, compression therapy has been used as the mainstay of venous disease therapy. In addition, numerous surgical techniques have been adopted. These include avulsion (phlebectomy) of varicosities, saphenous vein stripping, and ligation of the saphenofemoral junction (SFJ).6Overrecentyearsmany surgicaloptionshavebeenreplacedbyminimallyinvasivetechniques withlowercomplications,fasterrecovery,andcomparablesuccessrates.Theseincludethermalablation, forexample, laserandradiofrequency, andnonthermalablation,for example, nontumescentnonthermal (NTNT)techniques(foamsclerotherapy,mechanochemicalablation,andcyanoacrylateglue).Thecurrent USandUKguidelines(AmericanVenousForum/SocietyofVascularSurgeryandtheNationalInstitutefor HealthandCareExcellence)recommendendovenousthermalablationinpreferencetosurgicaltreatment forsaphenousvein incompetence.
7,8
These nonsurgical techniquesare less invasive, safer, andrequire
less convalescence time. There are few strong contraindications to venous ablation, but they include pregnancy and femoral/popliteal vein occlusion.9 In this chapter, we review the contemporary endovascularandapproachestotreatsuperficialvenousdisease.
II.CompressionTherapy
A.CompressionStockings
1. Regardless of thepathophysiology, refluxor obstruction,the mainstayof therapy invenousdisease
remains compression.10 Compression stockings are utilized as they are thought to compensate for increasedambulatoryvenouspressure,forpreventionofdeepandsuperficialveinthrombosis,reduction ininflammation,swellingandpain.Inadditiontovariousformsofstocking,compressioncanbeprovided withbandagesaswellaspneumaticdevices.
2.ConradJobstmadetheobservationthathydrostaticpressuresinapoolrelievedvenousinsufficiency
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symptoms. Theapplied pressure was greater withdepth, and inthe 1950s he developed compression stockingstoemulatethem.
11
a. The ankle venous pressure represents the weight of the column of blood leading up to the right
atrium.Whilelowinthesupineposition,anklevenouspressuresrisecloserto80-100mmHgupon standing. When venous valves are healthy, the use of the calf pump dramatically reduces this pressure.
b. In venous insufficiency, compression stockings can help improve venous return and reduce
ambulatoryvenouspressure
12,13
inpartbyusingaStarlinggradientthatfavorsedemaresolution.
14
B.C5/C6Disease
1.ForC5/C6disease(healedoractivevenousulcer)twoCochranereviewshavereportedlowerulcer
recurrencewithcompressiontherapy.Compressionnoncomplianceisassociatedwithlowerulcerhealing andgreaterrecurrence.
10,15
Higherpressurecompressionmayworkbetterthanmediumcompressionto
preventrecurrence.
15
2. El-Sheika’s
16
systematic review of randomized control trials on posttreatment compression found
sevensuitable for analysis. Three studies were surgical, two used sclerotherapy, and twoendovenous laserablation(EVLA).Heterogeneityinstudyqualityanddurationofcompressionmade meta-analysis difficult. No specific conclusions could be drawn about efficacy or optimal duration of compression therapy. Two studies suggested that longer compression resulted in less postprocedural pain. Bakker et al
17
randomized patients undergoing EVLA of the GSV to 2 versus 7 days of compression stockings (35mmHg).At1-weekfollow-up,the7-daycompressiongroupreportedlesspainandbetterphysical function. Another similarly designed prospective study noted a small but significant reduction in pain scoreswhencompressionwaswornafterEVLA.18Thesestudiesdidnotdemonstrateany differencein proceduralsuccessorablativeefficacy.
C.Evidence
Theevidenceforcompressiontherapyisdiscussedinmoredetailinareviewbythischapter’sauthor.
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III.LaserAblation
A.EndovenousLaserAblation
Endovenouslaser ablation(EVLA) was initially describedbyBoné andNavarro
20,21
using an 810 nm
diodelaser.Usingultrasoundguidance,alaserfiber(withorwithoutasheath)isinsertedintotheGSVat typicallythekneelevelandadvancedtoward theSFJ.Localanestheticwas initially usedbuthasnow beensupersededbytumescentanesthesia(saline,lidocaine,bicarbonate,andepinephrine).Theactivated laserfiberheatstheveinandgeneratessteambubbles.Itiswithdrawnatasteadyratealongthevein.In animalmodels,fibertemperaturesinexcessof1000°Chavebeenrecorded.
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B.EndovenousLaserAblationTreatment
The treatment results in the thrombosis, gradual necrosis, and shrinkage of the treated vein.
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Postprocedure compression is recommended. Successful closure rates, based mostlyon observational
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studies,havebeenintherangeof90%-98%.
24,25
Various laser fiber wavelengthshavebeendeveloped, which typicallyfocusenergyfor absorption by eitherred bloodcells orwater.A1470 nm wavelengthlaser,for example, targets water.The810 and 980nmwavelengths target hemoglobin.Thewater-focusedhigherwavelengthlasers mayresultinless discomfortandbruising.
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C.EndovenousLaserAblationComplications
ComplicationsofEVLA,similartoradiofrequencyablation(RFA),includeecchymosis,hematoma,skin burns,nerveinjury(thesaphenousnervecoursesclosetotheGSVbelowthemid-calfandthesuralnerve courses close to the small saphenous vein (SSV) distally), and endothermal heat–induced thrombosis (EHIT).
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IV.RadiofrequencyAblation
A.VNUSClosureSystem
Useofheatfromradiofrequencyenergytoablatethe GSVwasfirstdescribedbyGoldman28using the VNUSClosureSystem(Sunnyvale,CA).Asheathwasinsertedintothesaphenousveininthekneeregion, throughwhichthe radiofrequencyfiber was advancedmore proximallytothesaphenofemoral junction. Theelectrodetipelementgeneratedlocalheat(85°C)whichburnedtheveinwall.Theoriginalprotocol involvedslowsteadypullbackofthecatheter.Tofacilitateveinemptyingandocclusion,theprocedure wasperformedinreverseTrendelenburgandcompressionbandagingwasapplied.
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B.MedtronicClosureFastDevice
1. The current iteration is the Medtronic ClosureFast device (Minneapolis, MN) (Fig. 24.1). For
saphenousveinablationitcomeswitha3-or7-cmheatingelement,reaching120°C.Eachveinsegment is treated for 20 seconds before the fiber is repositioned to the adjacent segment. The procedure is performed with tumescentanesthesia, administered around the veinandtypicallywithinthe saphenous fascia. Ourusual practice is toadd 250 mg (25 mL) 1% lidocaine withepinephrine (1:100,000) plus
2.5mLof8.4%sodiumbicarbonatetoabagof500mLsaline(afterdiscardingapproximately25mLof saline).This creates a 500 mL bag of0.05% lidocainesolution. The tumescentanesthetic is typically refrigerated before administration. Thenet effect is to create local anesthesia, a heat sink as well as vasoconstriction,improvingcontactoftheheatingelementwiththevein.Inourexperience,bicarbonate reduces the discomfort of the injections. The tumescent anesthesia can also be used to ensure the saphenousveinisatleast1cmdeeptothedermis,topreventskinburnswiththermalablation.Itcanalso helpcreateseparationfromnervesincertainlocations.
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FIGURE24.1 TheMedtronicClosureFastradiofrequencyablationdevice(fiberandgenerator).
UsedwithpermissionbyMedtronic©2019.
2.Patientsarerecommendedtowearcompressionstockingsforupto2weekspostablation.Thereisno
strongevidencethatcompressionimprovestheefficacyofthermalablation,butitmaylowerdiscomfort.
16,17,30
3. Five-yearfollow-updataforradiofrequencyablationoftheGSV (295GSVs in225patients) found
occlusionrates of 92%, with95% free of refluxandonly sixpatients reporting ongoingsymptoms.
31
Symptomsandqualityoflifescoresimprovedramaticallyafterablation.
32–34
C.RadiofrequencyAblationComplications
1.TherangeofRFAcomplicationsandtheirratesaresimilartoEVLA.
27,35
EHITisrarewithmeticulous
technique. Lawrenceetal36 (Fig.24.2) describe a classification systemfor EHITbased onextent of bulginganddeepveininvolvement.From500patientsundergoingRFAtotheGSV,thrombusbulginginto the femoral vein was seen in2.6%. Even without anticoagulation,all thrombi retracted to the SFJ at approximately16-dayfollow-up,withnocasesofdeepveinthrombosis(DVT).
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FIGURE24.2 Classificationofendothermalheat–inducedthrombosis(EHIT).Level1:thrombusdistaltothe
levelofthesuperficialepigastricvein.Level2:closurewiththrombusextensionflushwiththeorificeofthe
epigastricvein.Level3:closurewiththrombusextensionflushwiththesaphenofemoraljunction.Level4:closure
withthrombusbulgingintothecommonfemoralvein.Level5:closurewithproximalthrombusextensionadherentto
theadjacentwallofthecommonfemoralveinpastthesaphenofemoraljunction.Level6:closurewithproximal
thrombusextensionintothecommonfemoralvein,consistentwithadeepveinthrombosis(DVT).EHITlevels1-3
aretypicallynotanticoagulated.
From
LawrencePF,ChandraA,WuM.Classificationofproximalendovenousclosurelevelsandtreatmentalgorithm.JVascSurg.2010;52:388-393.
2. In our laboratory, it is common practice to anticoagulate EHIT types 4-6, ie, in any cases where
thrombus extends into the deep venous system. For types 4 and5 we repeat ultrasound imagingin 1­2weeksandstopanticoagulationifthethrombushasbecomeflushattheSFJ.Withtype6,anticoagulation isadministeredlonger,forupto3months.
D.EndothemalHeat–InducedThrombosisWithAblation
AsimilarevaluationandclassificationsystemhasbeenproposedforEHITwithablationoftheSSV.
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AfterRFAoftheSSVin80limbs,3%experiencedEHIT,withthrombusextensionintothepoplitealvein. NoocclusiveDVTsoccurred.SimilartoEHITwithGSV,weanticoagulatepatientswith anythrombus extensionintothepoplitealvein.Ifthereisthrombusbulgeintothepoplitealveinwithoutocclusion,we normallyanticoagulatefor 1-2 weeksandrepeat imaging.We stop anticoagulationif thethrombushas
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becomeflushatthesaphenopoplitealjunction.
V.MechanochemicalAblation
Mechanochemical ablation (MOCA) combines abrasion of venous endothelium by a rapidly rotating metalelementwithchemicalablationbysclerotherapy.
A.ClariVeinDevice
MOCA(Fig.24.3)withtheClariVeindevice(VascularInsights,Quincy,MA)wasapprovedbytheFDA in2015andisalsoapprovedinEurope.Saphenousveinaccessisobtainedthrougha4-Frsheath,through whichthedeviceisadvancedclosetotheGSV.Typically,theprocedureiscommenced2cmdistaltothe SFJorthesuperficialepigastricvein.Themetallictipofthedevicerotatesatapproximately3,500RPM. Sclerosantscanbeinjectedthroughthemetallicviaasyringeloadedonthedevicehandle.Asthisaction isperformed,thedeviceiswithdrawnslowlyatarateofapproximately1cm,every7-10seconds.Itis recommendedtoapplymanualcompressivepressureespeciallywithveindiametersof1cmorgreater. As with other nonthermal technologies, no tumescent anesthesia is required. Owing to the lack of anesthesia,thepatientcanfeeldiscomfortparticularlyifthewiretipcatchesavalve.Inthosecases,local lidocaineanesthetic can be givenor the wire tip can be resheathed, withdrawnslightly and restarted. Patients are advised to pump their foot or better still walk around, immediately after the MOCA procedure.Compressionwrappingisapplied.
B.MechanochemicalAblationVersusRadiofrequencyAblation
Inaprospectivehead-to-headcomparisonofMOCAversusRFA(totaln=119),at1-monthfollow-up, 83%oftheMOCAgroupand92%oftheRFAgroupdemonstratedcompleteGSVclosure.In9%ofthe MOCAgrouponlythe proximalGSV was occluded.Proceduralpain scoreswerelowerintheMOCA group.Qualityoflifescoreimprovementswereequivalentinthetwogroups.Onelimitationofthisstudy wasthesizablelosstofollow-up.38Thecompletedstudyfindingswerepublishedmorerecently.39About 170 patients were randomized to MOCA versus RFA, with similar findings as Bootun et al.38 Most treatedveins (86%) were GSVs;the remainder (14%) were small saphenousveins (SSVs). Of these, 74% underwent concurrent phlebectomy. Six-month follow-up was completed in 71%. At 6 months, MOCAdemonstratedcompleteorproximalGSVocclusionin87%,versus93%forRFA.Venousclinical severityscoresshowedequivalentimprovement.
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VI.Sclerotherapy
A.VaricoseVeins
Sclerotherapyofvaricoseveinshasbeenusedinvariousformulations,fordecades.40Itresultsin vein thrombosis,fibrosis, andatrophy. Sclerotherapycanbe applied toany sizeveinfrom telangiectasia to large veinssuch as theGSV.41 Two ofthe leading sclerosants available are polidocanol and sodium tetradecylsulfate(STS).Bothbelongtothedetergentclass.Therecommendedstrengthsofpolidocanol are1%inlargevaricoseveins,0.5%inreticularveins,0.5%orlowerintelangiectasia(spiderveins). ForSTS,1%-1.5%inlargevaricoseveins,0.5%-1%inreticularveins,andapproximately0.2%-0.3%in telangiectasia.Forthefirstsclerotherapysession,wewouldrecommendlowerdosagestogaugepatient response.
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B.LiquidorFoamApplication
Sclerosantscanbeappliedasaliquidorfoam.Foamisconsideredmoreeffectiveinlargercaliberveins
41,42
asitdisplacesmorevenousbloodandthesclerosantbubblesallowforbettersclerosantcontactwith
thevenousendothelium.Bothairandcarbondioxidehavebeenusedtogeneratefoam.Asimplewayto generatefoamistheTessaritechniquethatusestwosyringesandathree-waystopcock.43Typicallyan air-to-liquidratioof4:1iscreatedbyvigorouslyflushingthetwosyringesbackandforth.
C.LiquidorFoamApplicationWithUltrasoundGuidance
1.Sclerotherapycanbeappliedusingultrasoundguidance.ForlargecaliberveinssuchastheGSV,past
datahaveshownfoamsclerotherapytobeinferiortoRFA,EVLA,andsurgicalstripping.
44,45
Darvallet
al46followed351patients(479limbs)afterultrasound-guidedfoamsclerotherapyforvaricoseveins.At 5-yearfollow-up81.2%wereevaluated.Anestimated15.3%hadrequiredretreatment.Highsatisfaction scoresaswellasimprovedsymptomsscoreswerereported.
2.Whilethereisnodefinitiveevidencethatcompressiontherapyimprovesthesuccessofsclerotherapy
fortelangiectasis,somesmallstudiessuggestitmayreducepigmentation.
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D.Varithena
1. Varithena,a proprietarycanistersystemtogenerateanddispense1%polidocanolfoamisavailable
from BTGInternational (London,UK)(Fig. 24.4). Thefoamhasagas-to-liquidratio ofapproximately 7:1andappearstohavegreaterstabilitythanphysician-compoundedfoam.Thegasisacombinationof O2andCO2.
2. Using ultrasoundguidance,asheath is placed into the veinof interest.A catheter is then advanced
throughthevein,typicallyatleast3cmdistaltotheSFJ,andaspirated.Thelegiselevated.Anultrasound probecanbeusedtomonitorthefoamenteringtheGSVandcanalsobeusedtocompressovertheSFJ. The catheter can be withdrawn as the foam is injected through it. Typically, compression is applied thereafterandlegelevationis maintainedfor10 minutes. Compressionwrapsor stockings areapplied andthepatient isadvisedtowalkrightaway. Themaximumrecommendedfoam dosage persessionis 15mLandeachcanistercontainsapproximately45mL.
3.VarithenawasapprovedbytheFDAin2013basedonthefindingsoftheVANISHPhaseIIIstudies.
VANISH-1showedimprovedpatient-reportedvenoussymptomscoresat8-weekswithacceptablesafety.
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In VANISH-2, 232 patients received 0.5%-1% polidocanol (Varithena) microfoam. By duplex
ultrasound, 84.7% showed “response”totreatment at8 weeks.A duplexresponsewas definedas the elimination of SFJ reflux and/or complete occlusion of the GSV and/or accessory veins identified as incompetentatbaseline.Sixtypercentreportedsomeadverseevent,mainlyretainedcoagulum,phlebitis, andpain.Commonfemoralveinthrombus extensionoccurredin3.9%andproximalDVTin2.6%with Varithena. Most of these adverse events were mild or moderate. Varithena was shown to improve symptomandappearancescoresat8weeks.Noneurologiceventswerereportedinthetreatmentgroup.
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4. Varithena has also been evaluated as an adjunct to endovenous thermal ablation. Vasquez et al
51
randomized 117 patients receiving RFA or EVLA to also receive 0.5% polidocanol (n = 39), 1% polidocanol(n=40),orplacebo(n=38).ThepatientshadGSVincompetenceandvisiblevaricosities. Thestudydrugcouldbeusedaboveandbelowthekneeforvisiblevaricosities,incompetentregionsof theGSVsystemortortuous areasofthesaphenoustrunknottreatedwiththermalablation.Thepatients were blinded for all interventions and polidocanol randomized cases were double-blinded. The combinedthermalandpolidocanoltreatedgroupshowedimprovedappearanceat8weeks.
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VII.Cyanoacrylate
A.Application
1.Todate,numerousformsofcyanoacrylateglue(CAG)havebeenusedinmedicine,forexampleasthe
skin adhesive Dermabond (Ethicon, Somerville, NJ), as a sealant in intracranial arteriovenous malformationsandpelvic andgastric varices.
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VeClose (n-butyl-2-cyanoacrylate), a form ofCAG,
withgreaterviscosityandfasterpolymerization(originallydevelopedbySapheon(Morrisville,NC)and acquiredbyMedtronic(Minneapolis,MN)isavailableforclosureofincompetentsaphenousveins.After vein occlusion the polymer is slowly absorbed leading to granuloma formation and vein fibrosis.
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VeClosewasFDAapprovedin2015andhasalsobeenapprovedinEurope.Eachdevicekitcomeswith CAG,catheter,guidewire,dispensergun,dispensertips,andsyringes(Fig.24.3).
FIGURE24.3 TheVenaSealcayanoacrylategluedevice.
UsedwithpermissionbyMedtronic©2019.
2. After placement ofa 5Fr introducer sheath into theGSV, the deliverycatheter is advanced 4-5 cm
caudaltotheSFJ.Theproximal GSVis compressedwithultrasound guidanceasCAGisinjected,and thencompressivepressureisapplied.Thecatheteriswithdrawn3cmbeforeanotherinjectionisgiven andcompressionreapplied,andsoon.Werecommendatleast30secondsofcompressivepressureafter eachadministration. Ultrasound is usedto confirmGSV occlusion.There is no needfor compression wrapspostprocedure.
B.eSCOPEStudy
In the prospective eSCOPE study (n = 70) CAG demonstrated a 93% closure rate at 12-months. Postproceduralphlebitiswasnotedin8.5%.55Inanotherstudy(n=108),at3monthsCAGdemonstrated 99%GSVclosureratesbyultrasound.56The2-yearresultsoftheeSCOPEtrialshowedVenaSealGSV closureratesof94.3% comparedwith94% withClosureFastRFA.55In theWAVESstudy, 50 patients withincompetentGSVs,SSVs,and/oraccessorysaphenousveins(diametersupto20mm)weretreated withVensSealcyanoacrylateclosure.At1month,alltreatedveinswereoccludedbyduplexultrasound
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andvenoussymptomscoreswereimproved.Postprocedurephlebitiswasnotedin20%.
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VIII.ComparisonStudies
A.RadiofrequencyAblationVersusEndovenousLaserAblation
1. Sydnoretal
58
performed a prospective randomizedstudyto compareRFablationwithEVLT with
980nmdiodelaserforGSVreflux.TheRFgroupexperiencedsignificantlylesspostprocedurepainand bruising.Overa1-yearfollow-upsymptomreliefwasequivalentaswasoverallpatientsatisfaction.
B.Ultrasound-GuidedFoamSclerotherapyVersusEndothermalAblation
Davisetal59reviewed all randomized controlled trial literature uptoJanuary2015. Six publications wereidentifiedwithvariableinclusioncriteriaandmethodologies.AnatomicalGSVclosurerateswere higherwiththermaltechnologies(RFAandEVLA).Patient-reportedqualityoflifescores,however,did notsignificantlydiffer.Foamsclerotherapywasmoreeconomical.
C."OUTLINE-END="outline-numbering-end-hereCyanoacrylateGlue
VersusEndovenousLaserAblation
Bozkurtetal60randomized310patientstoCAG(n= 154)versusEVLA(n =156) forablation ofthe GSVastheprimaryendpoint.PatientswithC2-C4bdiseasewereincluded.TheCAGwastheVariClose VeinSealingSystem(Biolas,Ankara,Turkey).TheEVLAwasa1470nmfiber.Therewassignificantly shorter operative time andprocedural painwith CAG. Inaddition, there was less ecchymosis and no casesofparesthesiainCAG,versus7casesoftemporaryorpermanentparesthesiawithEVLA.Twelve­month GSV closure rates were 95.8% with CAG and 92.2% with EVLA. Both groups experienced improved venous symptoms scores (Venous Clinical Severity Score and Aberdeen Varicose Vein Questionnaire),withnosignificantdifferencebetweenthetwoscores.
References
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