1 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, MD Frank R. Arko, MD Associate Professor of Surgery Associate Professor of Surgery Chief, Endovascular Surgery Chief, Endovascular Surgery University of Texas Southwestern University of Texas Southwestern Dallas, TX Dallas, TX
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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
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
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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Specific Treatments for DVTSpecific Treatments for DVT
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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Specific Treatments for DVTSpecific Treatments for DVT
– 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%
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
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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Case of Symptomatic DVTCase of Symptomatic DVT
ProcedureProcedure– Optional IVC filter placedOptional IVC filter placed– Patient then placed prone for popliteal vein Patient then placed prone for popliteal vein
SFV after mechanical SFV after mechanical thrombectomythrombectomy
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Competent Valve Post Competent Valve Post TreatmentTreatment
Valve
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Case of Symptomatic DVTCase of Symptomatic DVT
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
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
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
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10
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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
– 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
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