1 Lower Extremity DVT: Is an aggressive endovascular approach the way to go? Frank R. Arko, MD Associate Professor of Surgery Chief, Endovascular Surgery

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Lower Extremity DVT: Is an Lower Extremity DVT: Is an aggressive endovascular aggressive endovascular approach the way to go?approach the way to go?

Frank R. Arko, MDFrank R. Arko, MDAssociate Professor of SurgeryAssociate Professor of Surgery

Chief, Endovascular SurgeryChief, Endovascular SurgeryUniversity of Texas SouthwesternUniversity of Texas Southwestern

Dallas, TXDallas, TX

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Invasive Approaches to Treatment Invasive Approaches to Treatment of DVTof DVT

BackgroundBackground– Incidence is highIncidence is high

250,000 cases in US 250,000 cases in US alonealone

100,000 die annually from 100,000 die annually from PEPE

– Late MorbidityLate MorbidityRecurrent thrombosisRecurrent thrombosis

Postthrombotic syndromePostthrombotic syndrome

Patients with proximal Patients with proximal (ileofemoral) DVT most (ileofemoral) DVT most likely to have this likely to have this morbiditymorbidity

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Natural History and AnticoagulationNatural History and Anticoagulation

Untreated DVT will result in PE in Untreated DVT will result in PE in approximately 50% of patientsapproximately 50% of patients– Death in 20%Death in 20%

Anticoagulation reduces the risk of PE to Anticoagulation reduces the risk of PE to 1-2% in adequately dosed patients1-2% in adequately dosed patientsOnly 5% of patients rendered entirely Only 5% of patients rendered entirely asymptomatic asymptomatic At 2-years up to 70% of patients report At 2-years up to 70% of patients report symptomssymptoms

Saarinen et al, J CV Surg 2000O’Donnell et al, J Surg Research 1977

Kakkar et al. Am J Surg 1985Comerata et al, Phlebology 2000

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DVT Goals of TherapyDVT Goals of Therapy

Symptomatic Symptomatic improvementimprovement– Acute phase: outflow Acute phase: outflow

obstruction causes leg obstruction causes leg edema, pain, difficulty edema, pain, difficulty ambulatingambulating

– Relief of obstruction Relief of obstruction important to relieving important to relieving symptomssymptoms

Only 50% patients have Only 50% patients have regression of thrombus regression of thrombus with anticoagulation alonewith anticoagulation aloneMinority have venous Minority have venous recanalization with recanalization with anticoagulation aloneanticoagulation alone

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Specific Treatments for DVTSpecific Treatments for DVT

AnticoagulationAnticoagulation– Prevent PE, thrombus propagation, recurrent DVTPrevent PE, thrombus propagation, recurrent DVT– No chemical fibrinolytic activityNo chemical fibrinolytic activity

Intrinsic fibrinolysis occurs slowlyIntrinsic fibrinolysis occurs slowly

Clot lysis in only 10-50% of anticoagulated patientsClot lysis in only 10-50% of anticoagulated patients

– No preservation of venous valvesNo preservation of venous valves– Recurrent DVTRecurrent DVT

20% of patients within 5 years20% of patients within 5 years

2% risk of fatal PE2% risk of fatal PE

Inadequate intrinisic fibrinolysis may be biggest risk factorInadequate intrinisic fibrinolysis may be biggest risk factor

Marder et al, NEJM 1988Rogers et al, Am J Med 1990

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Treatment of DVTTreatment of DVT

Anticoagulation as “treatment” for acute DVT has little effect on the clot, and the

cycle of persistent symptoms, valve destruction , and ambulatory venous hypertension remains untreated

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Primary TreatmentPrimary Treatment

Removes or reduces the thrombusRemoves or reduces the thrombus– Surgical ThrombectomySurgical Thrombectomy– Catheter-Directed ThrombolysisCatheter-Directed Thrombolysis– Percutaneous Mechanical ThrombectomyPercutaneous Mechanical Thrombectomy

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Open Surgical Thrombectomy (Small Series)Open Surgical Thrombectomy (Small Series)– Juhan et al (1997): 84% long term patency (mean 8.5 Juhan et al (1997): 84% long term patency (mean 8.5

years) in 77 patientsyears) in 77 patientsValvular insufficiency in 20% at 5 years, 90 % no symptoms Valvular insufficiency in 20% at 5 years, 90 % no symptoms of venous insufficiencyof venous insufficiency

– Plate et al (1984) surgical thrombectomy v. Plate et al (1984) surgical thrombectomy v. anticoagulationanticoagulation

Leg edema, varicose veins, venous claudication 7% v. 42%Leg edema, varicose veins, venous claudication 7% v. 42%

Leg ulcerations 8% v. 18%Leg ulcerations 8% v. 18%

Not Widely Accepted

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Pharmacological ThrombolysisPharmacological Thrombolysis– Systemic thrombolysis poor resultsSystemic thrombolysis poor results

Only 10% thrombotic occlusions openedOnly 10% thrombotic occlusions openedSignificant Bleeding ComplicationsSignificant Bleeding Complications

– Catheter directed thrombolysisCatheter directed thrombolysisNational Venous Registry 1999National Venous Registry 1999Immediate complete or partial lysis in 84%Immediate complete or partial lysis in 84%Complete lysis in 31%Complete lysis in 31%1-year primary patency of 60%1-year primary patency of 60%

– Ileofemoral 64%Ileofemoral 64%– Femoralpopliteal 47%Femoralpopliteal 47%

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CDTCDT

AbuRahma et al, Ann Surg 2001AbuRahma et al, Ann Surg 2001– Complete resolution of symptoms in 83% vs Complete resolution of symptoms in 83% vs

3% for anticoagulation3% for anticoagulation

Comerota et al, JVS 2000Comerota et al, JVS 2000– Significant improvements in physical Significant improvements in physical

functioning, quality of life and PTS after functioning, quality of life and PTS after successful lysis compared to anticoagulationsuccessful lysis compared to anticoagulation

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National Venous RegistryNational Venous Registry

ComplicationsComplications– Minor bleeding complication 16%Minor bleeding complication 16%– Transfusion requirement 11%Transfusion requirement 11%– Pulmonary embolus 1%Pulmonary embolus 1%– Intracranial bleeding 0.2%Intracranial bleeding 0.2%

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Case of Symptomatic DVTCase of Symptomatic DVT

16 yo female with 16 yo female with acute onset of right acute onset of right thigh pain and thigh pain and shortness of breathshortness of breath– Ultrasound shows Ultrasound shows

CFV, SFV thrombosedCFV, SFV thrombosed

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ProcedureProcedure– Optional IVC filter placedOptional IVC filter placed– Patient then placed prone for popliteal vein Patient then placed prone for popliteal vein

accessaccessUltrasound guided accessUltrasound guided access

8 Fr sheath8 Fr sheath

Venogram performedVenogram performed

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IVC filter placedIVC filter placed

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VenogramVenogram

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SFV after mechanical SFV after mechanical thrombectomythrombectomy

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Competent Valve Post Competent Valve Post TreatmentTreatment

Valve

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Follow up UltrasoundFollow up Ultrasound– No evidence of No evidence of

thrombusthrombus

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Happy PatientsHappy Patients

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Percutaneous Percutaneous OptionsOptions

TRELLIS POSSIS

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TOP:TOP: Xpedior thrombectomy catheter. High velocity saline jets Xpedior thrombectomy catheter. High velocity saline jets create a localized low pressure zone at the catheter tip (Bernoulli create a localized low pressure zone at the catheter tip (Bernoulli

principle) for thrombus aspiration, break-up, and removal.principle) for thrombus aspiration, break-up, and removal.

BOTTOM:BOTTOM: Power Pulse-Spray lytic infusion in a thrombosed blood Power Pulse-Spray lytic infusion in a thrombosed blood vessel. The laterally-directed infusion is shown penetrating the vessel. The laterally-directed infusion is shown penetrating the

thrombus. thrombus.

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Power Pulse-Spray Concept:Power Pulse-Spray Concept: Left- Outer catheter tubing is Left- Outer catheter tubing is cut away to show internal stainless steel hypotube and distal cut away to show internal stainless steel hypotube and distal loop with exiting saline jets. The outflow lumen is occluded loop with exiting saline jets. The outflow lumen is occluded

using stopcock; thus lytic solution exits from distal windows. using stopcock; thus lytic solution exits from distal windows.

Right- Xpeedior catheter over .035” wire. Note mist of fluid Right- Xpeedior catheter over .035” wire. Note mist of fluid exiting at distal tip.exiting at distal tip.

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AngioJet/TNK Power Pulse AngioJet/TNK Power Pulse SpraySpray

Combined pharmacological thrombolysis & Combined pharmacological thrombolysis & mechanical thrombectomy mechanical thrombectomy

AdvantagesAdvantages– Enhance of the delivery of thrombolytic agentEnhance of the delivery of thrombolytic agent– Reduce duration of thrombolytic agentReduce duration of thrombolytic agent– Reduced ICU stayReduced ICU stay

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Possis AngiojetPossis Angiojet

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TRELLISTRELLIS®®-8 -8 Isolated Thrombolysis Isolated Thrombolysis

CatheterCatheterDesigned for Single Setting DVT Thrombolysis Designed for Single Setting DVT Thrombolysis

Pharmaco-mechanical drug infusion catheterPharmaco-mechanical drug infusion catheter

Treatment area contained within occluding Treatment area contained within occluding balloons (15, 30 cm zones)balloons (15, 30 cm zones)

Mechanical dispersion of infused thrombolytic Mechanical dispersion of infused thrombolytic agentsagents

Large 5-16 mm occluding balloonsLarge 5-16 mm occluding balloons

Aspiration following treatmentAspiration following treatment

8F, 035” system8F, 035” system

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Oscillating Dispersion WireOscillating Dispersion Wire

Pre-shaped Sinusoidal Wave with Pre-shaped Sinusoidal Wave with BiPlex constructionBiPlex construction

Attached to the ODUAttached to the ODU

Assists in dispersion of Assists in dispersion of thrombolytic agentthrombolytic agent

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TrellisTrellis

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Personal ExperiencePersonal Experience

Between October Between October 2002 and December 2002 and December 2006, 40 patients with 2006, 40 patients with DVT were captured DVT were captured prospectively in a prospectively in a vascular registry and vascular registry and retrospectively retrospectively reviewed. reviewed. 0

5

10

15

20

25

IF IFP FP SCV

Location

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TechniqueTechnique

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TechniqueTechnique

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TechniqueTechnique

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ResultsResults

Mean age was 50.9+/-18 yrs (range15-78) Mean age was 50.9+/-18 yrs (range15-78)

In 24/30(80%) treatment was performed at In 24/30(80%) treatment was performed at a single setting with a procedural time of a single setting with a procedural time of 145+/-35 minutes (55-210)145+/-35 minutes (55-210)

Recanalization of the venous segment Recanalization of the venous segment was achieved in all patients was achieved in all patients

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ResultsResults

TNK DoseTNK Dose CDTCDT CTA CTA AsymptomaticAsymptomatic

PEPE

TrellisTrellis

N=23N=23

6.2 mg6.2 mg 44 22

PossisPossis

N=17N=17

10 mg 10 mg 44 33

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Adjunctive ProceduresAdjunctive Procedures

0

5

10

15

20

25

Stent PTA IVCF IVCFR

Number

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Primary EndpointsPrimary Endpoints6 months6 months

0

5

10

15

20

25

30

35

40

Patency Valve Fxn

At Risk

Patent

90%88%

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Pre-Treatment VenogramPre-Treatment Venogram

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Post TreatmentPost Treatment Femoral Vein Femoral Vein

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Subclavian Vein Subclavian Vein ThrombosisThrombosis

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J Vasc Surgery 2004J Vasc Surgery 2004

Retrospective review of 20 patients with Retrospective review of 20 patients with symptomatic DVTsymptomatic DVT

Angiojet + lyticsAngiojet + lytics

Average time from diagnosis to treatment Average time from diagnosis to treatment was 14 dayswas 14 days

IVC filter used 7 out of 20 patientsIVC filter used 7 out of 20 patients

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ResultsResults– 61% had anatomic lesions uncovered after lysis61% had anatomic lesions uncovered after lysis

These were treated with PTA and stentingThese were treated with PTA and stenting

– 65% complete thrombus removal65% complete thrombus removal– 35% had partial improvement that was then 35% had partial improvement that was then

augmented with catheter – directed thrombolysis augmented with catheter – directed thrombolysis ( avg 5.7 hours). Dramatic improvement 2/8( avg 5.7 hours). Dramatic improvement 2/8

– 2 patients with thrombus in filter at end of case2 patients with thrombus in filter at end of case– Clinical symptomatic improvement in 74% casesClinical symptomatic improvement in 74% cases

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CDT vs PMTCDT vs PMT93 Patients93 Patients

46 CDT46 CDTComplete lysis 70%Complete lysis 70%Partial lysis 30%Partial lysis 30%Venograms 2.5Venograms 2.5Symptomatic Symptomatic Improvement 72%Improvement 72%LOS 8.4 daysLOS 8.4 daysPatency 1year 64%Patency 1year 64%

52 PMT52 PMTComplete lysis 75%Complete lysis 75%Partial lysis 25%Partial lysis 25%Venograms 0.4**Venograms 0.4**Symptomatic Symptomatic Improvement 81%Improvement 81%LOS 4.6 days**LOS 4.6 days**Patency 1year 68%Patency 1year 68%

Lin et al, American J Surg, 2006

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OmniWave™ Endovascular OmniWave™ Endovascular SystemSystem

OmniSonics Medical Technologies, Inc.OmniSonics Medical Technologies, Inc.66 Concord Street66 Concord Street

Wilmington, MA 01887Wilmington, MA 01887978-657-9980978-657-9980

www.omnisonics.comwww.omnisonics.com

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Catheter and GeneratorCatheter and Generator

SpecificationsSpecifications

≥≥ 7F sheath compatible7F sheath compatible

Distal OD: 1.9mm (6F)Distal OD: 1.9mm (6F)

Rapid ExchangeRapid Exchange

0.018” Compatible Guidewire0.018” Compatible Guidewire

100 cm usable length100 cm usable length

Treatment Zone ~10cmTreatment Zone ~10cm

Runtime = 10 minutesRuntime = 10 minutes

Able to treat 5-12 mm vesselsAble to treat 5-12 mm vessels

Irrigation fluid flowrate – 10 ml/minIrrigation fluid flowrate – 10 ml/min

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Theory of OperationTheory of Operation

The OmniWave Endovascular System uses high frequency mechanical The OmniWave Endovascular System uses high frequency mechanical vibrations (ultrasound) delivered via a thin waveguide to ablate thrombus vibrations (ultrasound) delivered via a thin waveguide to ablate thrombus and enhance infusionand enhance infusion

It is a revolutionary approach to clot management, with unique capabilities It is a revolutionary approach to clot management, with unique capabilities and characteristicsand characteristics

The system has two critical components:The system has two critical components:

– GeneratorGenerator

– Catheter SystemCatheter System

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Mechanism of ActionMechanism of Action

Cavitation is the working bubble that breaks up thrombusCavitation is the working bubble that breaks up thrombus

Microstreaming continually brings thrombus into contact with the Microstreaming continually brings thrombus into contact with the waveguidewaveguide

Macromotion brings the active energy to all parts of the vessel Macromotion brings the active energy to all parts of the vessel lumen.lumen.

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Omniwave (Chronic DVT)Omniwave (Chronic DVT)

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OmniwaveOmniwave

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OmniwaveOmniwave

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SummarySummary

CDT and the use of CDT and the use of PMT devices are PMT devices are emerging as emerging as significant significant breakthroughs in the breakthroughs in the treatment of DVTtreatment of DVT

Documents

1 Lower Extremity DVT: Is an aggressive endovascular approach the way to go? Frank R. Arko, MD Associate Professor of Surgery Chief, Endovascular Surgery