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

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

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 O’Donnell et al, J Surg Research 1977 Kakkar et al. Am J Surg 1985 Comerata et al, Phlebology 2000

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

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

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

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

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

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%

CDT AbuRahma et al, Ann Surg 2001 Comerota et al, JVS 2000 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

National Venous Registry Complications Minor bleeding complication 16% Transfusion requirement 11% Pulmonary embolus 1% Intracranial bleeding 0.2%

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

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

Case of Symptomatic DVT IVC filter placed

Case of Symptomatic DVT Venogram

Case of Symptomatic DVT SFV after mechanical thrombectomy

Competent Valve Post Treatment

Case of Symptomatic DVT Follow up Ultrasound No evidence of thrombus

Happy Patients

Percutaneous Options TRELLIS POSSIS

TOP: Xpedior thrombectomy catheter 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. 21

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. 22

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 23

Possis Angiojet

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

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

Trellis

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

Technique

Technique

Technique

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

Results TNK Dose CDT CTA AsymptomaticPE Trellis N=23 6.2 mg 4 2 Possis

Adjunctive Procedures

Primary Endpoints 6 months 90% 88%

Pre-Treatment Venogram

Post Treatment Femoral Vein

Subclavian Vein Thrombosis

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

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

Lin et al, American J Surg, 2006 CDT vs PMT 93 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

OmniWave™ Endovascular System OmniSonics Medical Technologies, Inc. 66 Concord Street Wilmington, MA 01887 978-657-9980 www.omnisonics.com

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

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

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. Cavitation, or bubble formation and collapse, is caused by the ultrasonic motion of the wire in a fluid medium resulting in a surface ablation of the tissues. When the “bubbles” collapse they cause a focused shock wave, acoustic energy , ablating tissue in a very controlled manner. In addition, the waveguide motion causes “microstreaming”, which causes thrombus to be continually drawn into contact with the wire. Finally, the waveguide moves within the vessel (“macromotion”) which brings the active energy to all parts of the vessel lumen.

Omniwave (Chronic DVT)

Omniwave

Omniwave

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