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

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

• Frank R. Arko, MD
• Associate Professor of Surgery
• Chief, Endovascular Surgery
• University of Texas Southwestern
• Dallas, TX

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Invasive Approaches to Treatment of DVT

• Background
• Incidence is high
• 250,000 cases in US alone
• 100,000 die annually from PE
• Late Morbidity
• Recurrent thrombosis
• Postthrombotic syndrome
• Patients with proximal (ileofemoral) DVT most
  likely to have this morbidity

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Natural History and Anticoagulation

• Untreated DVT will result in PE in approximately
  50 of patients
• Death in 20
• Anticoagulation reduces the risk of PE to 1-2 in
  adequately dosed patients
• Only 5 of patients rendered entirely
  asymptomatic
• At 2-years up to 70 of patients report symptoms

Saarinen et al, J CV Surg 2000 ODonnell et al, J
Surg Research 1977 Kakkar et al. Am J Surg
1985 Comerata et al, Phlebology 2000
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DVT Goals of Therapy

• Symptomatic improvement
• Acute phase outflow obstruction causes leg
  edema, pain, difficulty ambulating
• Relief of obstruction important to relieving
  symptoms
• Only 50 patients have regression of thrombus
  with anticoagulation alone
• Minority have venous recanalization with
  anticoagulation alone

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Specific Treatments for DVT

• Anticoagulation
• Prevent PE, thrombus propagation, recurrent DVT
• No chemical fibrinolytic activity
• Intrinsic fibrinolysis occurs slowly
• Clot lysis in only 10-50 of anticoagulated
  patients
• No preservation of venous valves
• Recurrent DVT
• 20 of patients within 5 years
• 2 risk of fatal PE
• Inadequate intrinisic fibrinolysis may be biggest
  risk factor

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

• Removes or reduces the thrombus
• Surgical Thrombectomy
• Catheter-Directed Thrombolysis
• Percutaneous Mechanical Thrombectomy

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Specific Treatments for DVT

• Open Surgical Thrombectomy (Small Series)
• Juhan et al (1997) 84 long term patency (mean
  8.5 years) in 77 patients
• Valvular insufficiency in 20 at 5 years, 90 no
  symptoms of venous insufficiency
• Plate et al (1984) surgical thrombectomy v.
  anticoagulation
• Leg edema, varicose veins, venous claudication 7
  v. 42
• Leg ulcerations 8 v. 18

Not Widely Accepted
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Specific Treatments for DVT

• Pharmacological Thrombolysis
• Systemic thrombolysis poor results
• Only 10 thrombotic occlusions opened
• Significant Bleeding Complications
• Catheter directed thrombolysis
• National Venous Registry 1999
• Immediate complete or partial lysis in 84
• Complete lysis in 31
• 1-year primary patency of 60
• Ileofemoral 64
• Femoralpopliteal 47

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CDT

• AbuRahma et al, Ann Surg 2001
• Complete resolution of symptoms in 83 vs 3 for
  anticoagulation
• Comerota et al, JVS 2000
• Significant improvements in physical functioning,
  quality of life and PTS after successful lysis
  compared to anticoagulation

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National Venous Registry

• Complications
• Minor bleeding complication 16
• Transfusion requirement 11
• Pulmonary embolus 1
• Intracranial bleeding 0.2

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Case of Symptomatic DVT

• 16 yo female with acute onset of right thigh pain
  and shortness of breath
• Ultrasound shows CFV, SFV thrombosed

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Case of Symptomatic DVT

• Procedure
• Optional IVC filter placed
• Patient then placed prone for popliteal vein
  access
• Ultrasound guided access
• 8 Fr sheath
• Venogram performed

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Case of Symptomatic DVT

• IVC filter placed

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Case of Symptomatic DVT

• Venogram

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Case of Symptomatic DVT

• SFV after mechanical thrombectomy

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Competent Valve Post Treatment
Valve
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Case of Symptomatic DVT

• Follow up Ultrasound
• No evidence of thrombus

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Happy Patients
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Percutaneous Options
TRELLIS
POSSIS
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TOP Xpedior thrombectomy catheter. High velocity
saline jets create a localized low pressure zone
at the catheter tip (Bernoulli principle) for
thrombus aspiration, break-up, and
removal.BOTTOM Power Pulse-Spray lytic
infusion in a thrombosed blood vessel. The
laterally-directed infusion is shown penetrating
the thrombus.
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Power Pulse-Spray Concept Left- Outer catheter
tubing is cut away to show internal stainless
steel hypotube and distal loop with exiting
saline jets. The outflow lumen is occluded using
stopcock thus lytic solution exits from distal
windows. Right- Xpeedior catheter over .035
wire. Note mist of fluid exiting at distal tip.
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AngioJet/TNK Power Pulse Spray

• Combined pharmacological thrombolysis
  mechanical thrombectomy
• Advantages
• Enhance of the delivery of thrombolytic agent
• Reduce duration of thrombolytic agent
• Reduced ICU stay

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Possis Angiojet
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TRELLIS-8 Isolated Thrombolysis Catheter

• Designed for Single Setting DVT Thrombolysis
• Pharmaco-mechanical drug infusion catheter
• Treatment area contained within occluding
  balloons (15, 30 cm zones)
• Mechanical dispersion of infused thrombolytic
  agents
• Large 5-16 mm occluding balloons
• Aspiration following treatment
• 8F, 035 system

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Oscillating Dispersion Wire

• Pre-shaped Sinusoidal Wave with BiPlex
  construction
• Attached to the ODU
• Assists in dispersion of thrombolytic agent

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Trellis
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Personal Experience

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

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Technique
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Technique
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Technique
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Results

• Mean age was 50.9/-18 yrs (range15-78)
• In 24/30(80) treatment was performed at a single
  setting with a procedural time of 145/-35
  minutes (55-210)
• Recanalization of the venous segment was achieved
  in all patients

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Results
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Adjunctive Procedures
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Primary Endpoints6 months
90
88
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Pre-Treatment Venogram
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Post Treatment Femoral Vein
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(No Transcript)
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Subclavian Vein Thrombosis
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• J Vasc Surgery 2004
• Retrospective review of 20 patients with
  symptomatic DVT
• Angiojet lytics
• Average time from diagnosis to treatment was 14
  days
• IVC filter used 7 out of 20 patients

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• Results
• 61 had anatomic lesions uncovered after lysis
• These were treated with PTA and stenting
• 65 complete thrombus removal
• 35 had partial improvement that was then
  augmented with catheter directed thrombolysis (
  avg 5.7 hours). Dramatic improvement 2/8
• 2 patients with thrombus in filter at end of case
• Clinical symptomatic improvement in 74 cases

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CDT vs PMT93 Patients

• 46 CDT
• Complete lysis 70
• Partial lysis 30
• Venograms 2.5
• Symptomatic Improvement 72
• LOS 8.4 days
• Patency 1year 64

• 52 PMT
• Complete lysis 75
• Partial lysis 25
• Venograms 0.4
• Symptomatic Improvement 81
• LOS 4.6 days
• Patency 1year 68

Lin et al, American J Surg, 2006
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OmniWave Endovascular System

• OmniSonics Medical Technologies, Inc.
• 66 Concord Street
• Wilmington, MA 01887
• 978-657-9980
• www.omnisonics.com

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Catheter and Generator

• Specifications
• 7F sheath compatible
• Distal OD 1.9mm (6F)
• Rapid Exchange
• 0.018 Compatible Guidewire
• 100 cm usable length
• Treatment Zone 10cm
• Runtime 10 minutes
• Able to treat 5-12 mm vessels
• Irrigation fluid flowrate 10 ml/min

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Theory of Operation

• The OmniWave Endovascular System uses high
  frequency mechanical vibrations (ultrasound)
  delivered via a thin waveguide to ablate thrombus
  and enhance infusion
• It is a revolutionary approach to clot
  management, with unique capabilities and
  characteristics
• The system has two critical components
• Generator
• Catheter System

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Mechanism of Action

• Cavitation is the working bubble that breaks up
  thrombus
• Microstreaming continually brings thrombus into
  contact with the waveguide
• Macromotion brings the active energy to all parts
  of the vessel lumen.

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Omniwave (Chronic DVT)
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Omniwave
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Omniwave
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Summary

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