1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

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

8. 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

9. 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%

10. 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

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

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

13. 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

14. Case of Symptomatic DVT
IVC filter placed

15. Case of Symptomatic DVT
Venogram

16. Case of Symptomatic DVT
SFV after mechanical thrombectomy

17. Competent Valve Post Treatment

18. Case of Symptomatic DVT
Follow up Ultrasound
No evidence of thrombus

19. Happy Patients

20. Percutaneous Options
TRELLIS
POSSIS

21. 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

22. 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

23. 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

24. Possis Angiojet

25. 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

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

27. Trellis

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

29. Technique

30. Technique

31. Technique

32. 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

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

34. Adjunctive Procedures

35. Primary Endpoints 6 months
90%
88%

36. Pre-Treatment Venogram

37. Post Treatment Femoral Vein

39. Subclavian Vein Thrombosis

40. 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

41. 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

42. 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

43. OmniWave™ Endovascular System
OmniSonics Medical Technologies, Inc.
66 Concord Street
Wilmington, MA 01887

44. 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

45. 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

46. 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.

47. Omniwave (Chronic DVT)

48. Omniwave

49. Omniwave

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