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1 European Venous Centre; Aachen-Maastricht European Venous Centre; Aachen-Maastricht Prof. Cees H.A. Wittens, MD PhD Head of Venous Surgery Maastricht University Medical Center Uniklinik Aachen Uniklinik Aachen What is new in Deep Venous Disease V E C

What is new in deep venous disease

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1European Venous Centre; Aachen-MaastrichtEuropean Venous Centre; Aachen-Maastricht

Prof. Cees H.A. Wittens, MD PhDHead of Venous SurgeryMaastricht University Medical CenterUniklinik AachenUniklinik Aachen

What is new in Deep Venous Disease

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VE CEuropean Venous Centre; Aachen-MaastrichtEuropean Venous Centre; Aachen-Maastricht

IntroductionIntroduction New in Deep Venous Thrombosis (DVT)New in Deep Venous Thrombosis (DVT)

Standard care DVTStandard care DVT

Etiology PTSEtiology PTS

Diagnostics DVTDiagnostics DVT

Scoring system DVTScoring system DVT

Treatment OptionsTreatment Options

○ Conservative Conservative

○ InvasiveInvasive

○ New in Deep Venous Obstruction (DVO = > 80% PTS)New in Deep Venous Obstruction (DVO = > 80% PTS)○ DiagnosticsDiagnostics

○ Indications for treatmentIndications for treatment

○ Treatment optionsTreatment options○ StentingStenting

○ EndophlebectomyEndophlebectomy

○ Miscellaneous Miscellaneous

○ ConclusionConclusion

Complications of standard (level1 Complications of standard (level1 evidence) DVT treatment:evidence) DVT treatment:

Pulmonary embolism (5% lethality)Pulmonary embolism (5% lethality)

Recurrent thrombosis (30%)Recurrent thrombosis (30%)

Overall 25% PTS within 1 year.Overall 25% PTS within 1 year.

Iliofemoral thrombosis is associated Iliofemoral thrombosis is associated with a twofold increased risk of with a twofold increased risk of developing PTS >> 50%.developing PTS >> 50%.11

Early thrombolysis may decrease Early thrombolysis may decrease incidence PTS.incidence PTS.

1: Kahn, Ginsberg. Arch Intern Med 2004 3 33European Venous Centre; Aachen-MaastrichtEuropean Venous Centre; Aachen-Maastricht

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Standard care in DVTStandard care in DVT

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Etiology of PTSEtiology of PTS 20-82% of pt’s develop PTS after DVT20-82% of pt’s develop PTS after DVT PTS due to deep venous PTS due to deep venous obstructionobstruction::

Calf: Calf: PTS is rarePTS is rarePopliteal: Popliteal: PTS is rarePTS is rareFemoral: Femoral: commoncommonIliac/caval: Iliac/caval: commoncommon

○ Only 20-30% of thrombosed iliac veins Only 20-30% of thrombosed iliac veins completely recanalize with anticoagulant completely recanalize with anticoagulant therapytherapy

44% claudication 5 years post iliac DVT44% claudication 5 years post iliac DVT15% ulcers 5 years post iliac DVT15% ulcers 5 years post iliac DVT

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VE CEuropean Venous Centre; Aachen-MaastrichtEuropean Venous Centre; Aachen-Maastricht

Diagnostics in DVTDiagnostics in DVT

Due to changed therapeutic Due to changed therapeutic options there is a need to options there is a need to change diagnostics in DVT change diagnostics in DVT 2 point compression ultrasound 2 point compression ultrasound

(not enough!!)(not enough!!)

Complete venous roadmap !!Complete venous roadmap !!Full duplex examinationFull duplex examinationMRVMRVCTVCTV

A Standardized A Standardized classif icationclassif ication

6European Venous Centre; Aachen-MaastrichtEuropean Venous Centre; Aachen-Maastricht

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LET LET (Lower extremity thrombosis) (Lower extremity thrombosis) classification:classification:

› Class I: calf vein thrombosis: calf vein thrombosis Limited to the calf veinsLimited to the calf veins

Good recanalisationGood recanalisation Good outflow / collateralsGood outflow / collaterals Low PTSLow PTS

› Class II: femoro-popliteal thrombosis: femoro-popliteal thrombosis Popliteal vein, Femoral vein, Deep femoral veinPopliteal vein, Femoral vein, Deep femoral vein

Good recanalisationGood recanalisation Good outflow / collateralsGood outflow / collaterals Medium PTSMedium PTS

› Class III: femoro-iliac thrombosis: femoro-iliac thrombosis Common femoral vein, iliac veinsCommon femoral vein, iliac veins

Bad recanalisationBad recanalisation Impaired outflow / bad collateralsImpaired outflow / bad collaterals High PTSHigh PTS

› Class IV: inferior vena cava thrombosis: inferior vena cava thrombosis Inferior vena cavaInferior vena cava

Bad recanalisationBad recanalisation Impaired outflow / bad collaterals / bilateralImpaired outflow / bad collaterals / bilateral High PTSHigh PTS

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VE CEuropean Venous Centre; Aachen-MaastrichtEuropean Venous Centre; Aachen-Maastricht

Scoring system in DVTScoring system in DVT

This system will help to document the This system will help to document the pathology in a standardized fashionpathology in a standardized fashion

Make individual clinical decisions Make individual clinical decisions possible depending on the classificationpossible depending on the classification

Makes future research comparable Makes future research comparable (Meta-analyses)(Meta-analyses)

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•Why intervention:Why intervention:•Reduction symptoms (acute stage)Reduction symptoms (acute stage)•Reduction recurrent DVTReduction recurrent DVT•Reduction PTS (by recanalisation and valve Reduction PTS (by recanalisation and valve preservation)preservation)

•In whom:In whom:•Iliofemoral (cava) thrombosisIliofemoral (cava) thrombosis

•Poor recanalisation causing:Poor recanalisation causing: Venous hypertension (95%)Venous hypertension (95%) DVI (90%)DVI (90%) Calve muscle pump dysfunction (50%)Calve muscle pump dysfunction (50%) Venous claudication (15%)Venous claudication (15%) Ulcers (15%)Ulcers (15%) >50 %PTS>50 %PTS

DVT: DVT: interventionintervention

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VE CEuropean Venous Centre; Aachen-MaastrichtEuropean Venous Centre; Aachen-Maastricht

Invasive treatment options: Invasive treatment options: DVTDVT

ConservativeConservative thrombolysisthrombolysis

Systemic Systemic (obsoleet)(obsoleet)

CDTCDT○ PTS 14,4% PTS 14,4% ARRARR

CavenT studyCavenT studyEKOSEKOSTrellisTrellisAngiojetAngiojet

All 80-95% All 80-95%

succesfull recanalisationsuccesfull recanalisation

Vasculaire SpecialisatieE CV

Maastricht-Aken

E CV

ANGIOJET

EVC results for iliofemoral thrombolysisEVC results for iliofemoral thrombolysisEVC results for iliofemoral thrombolysisEVC results for iliofemoral thrombolysis13

VE CEuropean Venous Centre; Aachen-MaastrichtEuropean Venous Centre; Aachen-Maastricht

Treatment options: Treatment options: iliofemoral DVTiliofemoral DVT

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Treatment options: Treatment options: DVTDVT

If it has been shown that a successful thrombus If it has been shown that a successful thrombus removal significantly improves outcome (removal significantly improves outcome (PTS, PTS, recurrent DVT and QoL)recurrent DVT and QoL) CavenTCavenT

AttractAttract

CAVACAVA

We need better dedicated devicesWe need better dedicated devices○ Ideally as a 1 hour out patient procedureIdeally as a 1 hour out patient procedure○ Without thrombolyticsWithout thrombolytics

ComplicationsComplications Medium care admission Medium care admission Costs Costs Malignancies can be treated !Malignancies can be treated ! Postoperative patients can be treated !Postoperative patients can be treated !

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VE CEuropean Venous Centre; Aachen-MaastrichtEuropean Venous Centre; Aachen-Maastricht

Treatment options: Treatment options: DVTDVT

New dedicated venous thrombus removal New dedicated venous thrombus removal devices will be developed:devices will be developed: Removal of thrombi with local lytic therapyRemoval of thrombi with local lytic therapy

○ Covidien (Trellis II)Covidien (Trellis II) Remove thrombi without lytic agentsRemove thrombi without lytic agents

○ Lazarus Lazarus

Thrombectomy device (4F)Thrombectomy device (4F)

○ AngiodynamicsAngiodynamics Thrombectomy device (14F)Thrombectomy device (14F) Angiovac (22F)Angiovac (22F)

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Treatment options: Treatment options: DVTDVT

New dedicated venous thrombus removal New dedicated venous thrombus removal devices will be developed:devices will be developed: Removal of thrombi with Removal of thrombi with locallocal lytic therapy lytic therapy

○ Covidien (Trellis II)Covidien (Trellis II) Remove thrombi without lytic agentsRemove thrombi without lytic agents

○ Lazarus Lazarus

Thrombectomy device (4F)Thrombectomy device (4F)

○ AngiodynamicsAngiodynamics Thrombectomy device (14F)Thrombectomy device (14F) Angiovac (22F)Angiovac (22F)

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Treatment options: Treatment options: DVTDVT

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Treatment options: Treatment options: DVTDVT

New dedicated venous thrombus removal New dedicated venous thrombus removal devices will be developed:devices will be developed: Removal of thrombi with local lytic therapyRemoval of thrombi with local lytic therapy

○ Covidien (Trellis II)Covidien (Trellis II) Remove thrombi without lytic agentsRemove thrombi without lytic agents

○ LazarusLazarus

Thrombectomy device (4F)Thrombectomy device (4F)

○ AngiodynamicsAngiodynamics Thrombectomy device (14F)Thrombectomy device (14F) Angiovac (22F)Angiovac (22F)

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50% 50% is stented and dedicated is stented and dedicated stent are coming to the market.stent are coming to the market.CookCookVenitiVenitiOptiMedOptiMed

Treatment options: Treatment options: DVTDVT

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VE CEuropean Venous Centre; Aachen-MaastrichtEuropean Venous Centre; Aachen-Maastricht

Conclusion:Conclusion:

What is new in DVT treatment:What is new in DVT treatment:Etiology PTSEtiology PTS Obstruction!!!Obstruction!!!DiagnosticsDiagnostics full venous roadmap!full venous roadmap!Scoring systemsScoring systems LET scoreLET scoreTreatment OptionsTreatment Options

○ DVT DVT (iliofemoral-caval)(iliofemoral-caval)○ New dedicated equipmentNew dedicated equipment

○ Thrombectomy devicesThrombectomy devices○ StentsStents○ NOAC’sNOAC’s

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VE CEuropean Venous Centre; Aachen-MaastrichtEuropean Venous Centre; Aachen-Maastricht

Conclusion:Conclusion:

What is new DVT treatment:What is new DVT treatment:

Potential impact on practice to treat Potential impact on practice to treat

DVT and prevent PTS:DVT and prevent PTS:

○ DVT 1/1000/yearDVT 1/1000/year

25 % ilio-femoral25 % ilio-femoral 25/100.000/year 25/100.000/year

Turkey: >>20.000 / yearTurkey: >>20.000 / year

Major impact if this treatment become routineMajor impact if this treatment become routine

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Venous hypertension:Venous hypertension:Deep venous insufficiency Deep venous insufficiency ( < 90 mmHg)( < 90 mmHg)

Deep venous Deep venous obstruction !! obstruction !! (> 200 mmHg)(> 200 mmHg)

DVO

Internal causes

External causes

DVT

May-Thurner

Ext. compression

Cancer

Lymphocele

Fibrosis

Aneurysm

ICV atresia

Immobility

Thrombofilia

Pregnancy

Treatment of DVOTreatment of DVO

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VE CEuropean Venous Centre; Aachen-MaastrichtEuropean Venous Centre; Aachen-Maastricht

EtiologyEtiology 29-82% of pt’s develop PTS after DVT29-82% of pt’s develop PTS after DVT PTS due to deep venous PTS due to deep venous obstructionobstruction::

Calf: Calf: PTS is rarePTS is rarePopliteal: Popliteal: PTS is rarePTS is rareFemoral: Femoral: commoncommonIliac/caval: Iliac/caval: commoncommon

○ 20-30% of thrombosed iliac veins completely 20-30% of thrombosed iliac veins completely recanalize with anticoagulant therapyrecanalize with anticoagulant therapy

44% claudication 5 years post iliac DVT44% claudication 5 years post iliac DVT15% ulcers 5 years post iliac DVT15% ulcers 5 years post iliac DVT

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VE CEuropean Venous Centre; Aachen-MaastrichtEuropean Venous Centre; Aachen-Maastricht

DiagnosticsDiagnostics

Clinical examination has to be performed Clinical examination has to be performed groin and abdominal wall: especially in groin and abdominal wall: especially in patients with:patients with: Venous ulcersVenous ulcers also in:also in:

C 4,5C 4,5 Venous claudicationVenous claudication Fast recurrent VaricositiesFast recurrent Varicosities

10-15 % will show signs10-15 % will show signs

of central venous obstruction!!of central venous obstruction!!

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DiagnosticsDiagnostics

Due to changed therapeutic Due to changed therapeutic options there is a need to options there is a need to change diagnostics in venous change diagnostics in venous ulcer diseaseulcer disease

Complete venous roadmap !!Complete venous roadmap !!Full duplex examinationFull duplex examinationMRVMRVCTVCTV

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VE CEuropean Venous Centre; Aachen-MaastrichtEuropean Venous Centre; Aachen-Maastricht

DiagnosticsDiagnostics

Literature search showed no Literature search showed no comparable results because comparable results because there are there are no reporting standards no reporting standards for deep venous pathology for deep venous pathology registrationregistration

LOVE scoreLOVE score

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Scoring systemsScoring systems LOLOwer extremity wer extremity VEVEnous pathology nous pathology

scoring systemscoring system Each segment:Each segment:

Post thrombotic leasionsPost thrombotic leasions Residual lumenResidual lumen

0 % (occlusion)0 % (occlusion) 10-50 %10-50 % 50-90 %50-90 % 90-100%90-100%

CollateralsCollaterals External compressionExternal compression

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VE CEuropean Venous Centre; Aachen-MaastrichtEuropean Venous Centre; Aachen-Maastricht

Treatment optionsTreatment options

Conservative:Conservative: CompressionCompression AnticoagulationAnticoagulation

Invasive:Invasive: PTA alone (obsoleet)PTA alone (obsoleet) PTA + stentingPTA + stenting BypassBypass + or -+ or -

○ EndophlebectomyEndophlebectomy

○ AV fistulaeAV fistulae

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Indications for treatment:Indications for treatment:

Improve QoL!!Improve QoL!!Skin problemsSkin problemsVenous claudication !Venous claudication !Swollen legsSwollen legsPainPain

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Inferior vena cava: Inferior vena cava: High radial force, minimal flexibility, large diameterHigh radial force, minimal flexibility, large diameter..

Common iliac vein: Common iliac vein: High radial force, high flexibility, large length of stent.High radial force, high flexibility, large length of stent.

External iliac vein: External iliac vein: High radial force, high flexibility, large length of stent.High radial force, high flexibility, large length of stent.

Common femoral vein: Common femoral vein: fracture resistant?!fracture resistant?!

Requirements for stents per segment Requirements for stents per segment

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European Venous Centre; Aachen-MaastrichtEuropean Venous Centre; Aachen-Maastricht

Compression of stent Compression of stent (radial force to low)(radial force to low)

Kinking of stent (high Kinking of stent (high rigidity) rigidity)

Tapering of stent Tapering of stent (especially Wallstent)(especially Wallstent)

Stent rigidityStent rigidityfracturefractureBamboo stick effect Bamboo stick effect

Shortcomings of stents todayShortcomings of stents today

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European Venous Centre; Aachen-MaastrichtEuropean Venous Centre; Aachen-Maastricht

Compression of stent Compression of stent (radial force to low)(radial force to low)

Kinking of stent (high Kinking of stent (high rigidity) rigidity)

Tapering of stent Tapering of stent (especially Wallstent)(especially Wallstent)

Stent rigidityStent rigidityfracturefractureBamboo stick effect Bamboo stick effect

Shortcomings of stents todayShortcomings of stents today

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E CV

European Venous Centre; Aachen-MaastrichtEuropean Venous Centre; Aachen-Maastricht

Compression of stent Compression of stent (radial force to low)(radial force to low)

Kinking of stent (high Kinking of stent (high rigidity) rigidity)

Tapering of stent Tapering of stent (especially Wallstent)(especially Wallstent)

Stent rigidityStent rigidityfracturefractureBamboo stick effect Bamboo stick effect

Shortcomings of stents todayShortcomings of stents today

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E CV

European Venous Centre; Aachen-MaastrichtEuropean Venous Centre; Aachen-Maastricht

Compression of stent Compression of stent (radial force to low)(radial force to low)

Kinking of stent (high Kinking of stent (high rigidity) rigidity)

Tapering of stent Tapering of stent (especially Wallstent)(especially Wallstent)

Stent rigidityStent rigidityfracturefractureBamboo stick effect Bamboo stick effect

Shortcomings of stents todayShortcomings of stents today

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E CV

European Venous Centre; Aachen-MaastrichtEuropean Venous Centre; Aachen-Maastricht

Compression of stent Compression of stent (radial force to low)(radial force to low)

Kinking of stent (high Kinking of stent (high rigidity) rigidity)

Tapering of stent Tapering of stent (especially Wallstent)(especially Wallstent)

Stent rigidityStent rigidityfracturefractureBamboo stick effect Bamboo stick effect

Shortcomings of stents todayShortcomings of stents today

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VE CEuropean Venous Centre; Aachen-MaastrichtEuropean Venous Centre; Aachen-Maastricht

CookCook VenitiVeniti OptiMedOptiMed

New Venous stentsNew Venous stents

New Sinus-Venous stentNew Sinus-Venous stent

Max. Flexibility and radial forceMax. Flexibility and radial force

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New Sinus-Venous stentNew Sinus-Venous stent

40 23

New Sinus-Venous stentNew Sinus-Venous stent

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New Sinus-Venous stentNew Sinus-Venous stent“Old” 2013 “New 2013”

Stents used Sinus XL, Wall, Silver Vena and Andra stents

Sinus Venous

No 63 35

Average follow-up time (y)

8.8 (±8.0, 1 – 31) 3.0 (±2.6, 1 - 10.2)

Patent at last follow up 87.3% 97.1%

Primary patent 74.3% 88.6% (P<0,05)

Patent after “primary assisted” intervention

81.4% -

Patent after “secondary” intervention

96.1% 97.1%

Number of reinterventions

23 in 13 (20.6%) patients

4 in 3 (8.6%) patients

(P<0,05)

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New dedicated venous stent available!New dedicated venous stent available!Silver Vena ?Silver Vena ?Veniti ?Veniti ?Sinus-Venous (OptiMed): Sinus-Venous (OptiMed):

better primary and secondary patencybetter primary and secondary patencyEasy deployment and positioningEasy deployment and positioningHigh flexibility with good alignmentHigh flexibility with good alignmentHigh radial forceHigh radial force

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ConclusionConclusion

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Improved inflow measures Improved inflow measures ○ Endophlebectomy (CFV involvement)Endophlebectomy (CFV involvement)○ AV fistulaAV fistula

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Indications for EndophlebectomyIndications for Endophlebectomy

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VE CEuropean Venous Centre; Aachen-MaastrichtEuropean Venous Centre; Aachen-Maastricht

ExperienceExperience

35 Patients35 Patients

Patients withPatients with

○CEAP C4-6CEAP C4-6

○Severe venous claudicationSevere venous claudication

Diagnosis of occlusion/obstructionDiagnosis of occlusion/obstruction

○Duplex ultrasoundDuplex ultrasound

○Magnetic resonance venographyMagnetic resonance venography

○Per-procedural venographyPer-procedural venography

Patency controlPatency control

○Duplex ultrasoundDuplex ultrasound

V

Improved inflow measures Improved inflow measures when CFV involvement on MRV when CFV involvement on MRV

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Desobstructie VFC with iliac stent

VEuropean Venous Centre; Aachen-MaastrichtEuropean Venous Centre; Aachen-Maastricht

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VE CEuropean Venous Centre; Aachen-MaastrichtEuropean Venous Centre; Aachen-Maastricht

DemographicsDemographics

Number of patientsNumber of patients 3535

Number of legsNumber of legs 3737

SexSex 20 female / 15 male20 female / 15 male

Average ageAverage age 40 (18 – 63)40 (18 – 63)

DVT episodeDVT episode First 24 / recurrent 11First 24 / recurrent 11

DVT sideDVT side L 23 / R 7 / Bilat 5L 23 / R 7 / Bilat 5

Time betw. DVT and Time betw. DVT and treatmenttreatment

7.6 (1 – 40)7.6 (1 – 40)

May-Thurner syndromeMay-Thurner syndrome 13 (37%)13 (37%)

Confirmed trombophiliaConfirmed trombophilia 6 (55%) 6 (55%) (of 11 tested)(of 11 tested)

Primary operationPrimary operation Stent 29 / bypass 6Stent 29 / bypass 6

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VE CEuropean Venous Centre; Aachen-MaastrichtEuropean Venous Centre; Aachen-Maastricht

Primary Primary operationoperation

PTA & stentingPTA & stenting 2929 83%83%

Venous bypassVenous bypass 66 17%17%

Side of bypassSide of bypass

CFV L CFV L CIV R CIV R 55 14%14%

CFV R CFV R CIV L CIV L 11 3%3%

Side of PTA & Side of PTA & stentingstenting

Left tractLeft tract 1212 34%34%

Right tractRight tract 77 20%20%

Left and centralLeft and central 44 11%11%

Bilateral and Bilateral and centralcentral

66 17%17%

Concurrent AV-Concurrent AV-fistulafistula

2929 83%83%

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Results - interventionResults - intervention

ReocclusionReocclusion 1111 31%31%

Wound infectionWound infection 33 9%9%

Lymph leakageLymph leakage 33 9%9%

SeromaSeroma 22 6%6%

Bleeding majorBleeding major 11 3%3%

Bleeding minorBleeding minor 11 3%3%

Pulmonary embolismPulmonary embolism 00 0%0%

MortalityMortality 00 0%0%

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Results – follow-upResults – follow-upAverage follow-upAverage follow-up 7,8 mo7,8 mo (1 – 23 mo)(1 – 23 mo)

Patent at last follow-upPatent at last follow-up 2828 81%81%

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Treatment options: Treatment options: miscellaneousmiscellaneous

Improved inflow measures / timingImproved inflow measures / timing○ AV fistulaeAV fistulae

SurgicalSurgicalPercutaneous (future)Percutaneous (future)

○ Postoperative pneumatic compression !!Postoperative pneumatic compression !!

Improved anticoagulationImproved anticoagulation○ Oral “Heparines”Oral “Heparines”

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Conclusion on Conclusion on endophlebectomyendophlebectomy

Endophlebectomy is relatively safeEndophlebectomy is relatively safe

○ Associated with low complications rates Associated with low complications rates

○ Except reocclusionExcept reocclusion However good secondary patency rateHowever good secondary patency rate

○ Indications AV fistulae ?Indications AV fistulae ?

Future:Future:

○Stenting into CFV or endophlebectomy tract?Stenting into CFV or endophlebectomy tract?

○Better AV fistulae?Better AV fistulae?

○Need for patches?Need for patches?

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VE CEuropean Venous Centre; Aachen-MaastrichtEuropean Venous Centre; Aachen-Maastricht

Conclusion in DVO:Conclusion in DVO:

What is new DVO treatment:What is new DVO treatment:

Potential impact on practice to treat Potential impact on practice to treat

DVO and PTS:DVO and PTS:

○ In Turkey In Turkey > 500.000 people> 500.000 people

have a significant deep venous outflow have a significant deep venous outflow

obstrucion:obstrucion:

Major impact if this treatment become routineMajor impact if this treatment become routine

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VE CEuropean Venous Centre; Aachen-MaastrichtEuropean Venous Centre; Aachen-Maastricht

Overall ConclusionOverall Conclusion

New DVT treatment optionsNew DVT treatment optionsIn patients with a LET III or IV DVTIn patients with a LET III or IV DVT

Better thrombectomie devicesBetter thrombectomie devices

Better stentsBetter stents

Improve QoLImprove QoL

Acute symptome relieveAcute symptome relieve

Reduce PTSReduce PTS

Reduce recurrent DVTReduce recurrent DVT

New DVO treatment optionsNew DVO treatment optionsIn patients with iliofemoral/caval occlusive diseaseIn patients with iliofemoral/caval occlusive disease

Better stentsBetter stents

EndophlebectomyEndophlebectomy

AV fistulaeAV fistulae

NOAC’sNOAC’s

Improve QoL !! Improve QoL !! Thank youThank you