Endovascular Treatment for Patients with Deep Vein Thrombosis (DVT)

1. Endovascular Treatment for Patients withDeep Vein Thrombosis (DVT) Dr. Matthew P. Namanny Saguaro Surgical Vascular and Endovascular Surgery

2. DVT - “A National Crisis…” - U.S. Surgeon General, 2008 • >600,000 Americans are diagnosed with DVT annually1 • 300,000 will develop Post Thrombotic Syndrome (PTS)2,4 • 120,000 will suffer recurrent VTE (DVT/PE)3 • VTE is the leading cause of preventable hospital death5 (DVT and PE) • DVT is the third most common CV Disease4 • U.S. spends $2.4B to Treat DVTannually2

3. Pathophysiology of DVT • Virchow Triad • Abnormalities of blood flow. • Abnormalities of blood. • Vascular injury.

4. Deep Vein Thrombosis

5. Complications of DVT • Pulmonary Embolism (PE). • Post Thrombotic Syndrome (PTS).

6. Venous Insufficiency

7. Risk Factors • Age • Travel • Immobilization • History of DVT • Malignancy • Surgery • Trauma

8. Risk Factors • Hypercoagulable States • Pregnancy • Oral Contraceptives • Central venous catheters • SLE

9. Deep Vein Thrombosis • If you had a DVT would you consider having it removed???

10. DVT: The Condition Disease Symptoms • Varying Pain levels • Swelling • Aching • Leg fatigue • Cramping, Itching, Burning • Asymptomatic Goldhaber, NATF, 3/08 • Observations • Dilation of superficial veins • Reticular or varicose veins • Edema • Skin changes • Asymptomatic • Treatment Goals • Prevention of: • Pulmonary Embolism (PE) • Thrombus propagation • DVT recurrence • Post Thrombotic Syndrome • Maintain valve competence

11. Treatment Options • Anticoagulation (Gold Standard). • Inferior vena cava filter • Interventional treatment.

12. The Evolution of DVT Treatment 30 Years 30 Years ~ Isolated Pharmaco- mechanical Thrombolysis Pharmaco- mechanical Thrombolysis Catheter Directed Thrombolysis Systemic Thrombolysis Anticoagulation Therapy

13. Anticoagulation Alone . . . …does prevent clot propagation1. …does reduce risk of pulmonary embolism. But, it typically… …does NOT resolve clot.16 …does NOT rapidly resolve symptoms.16 …does NOT prevent PTS (Post Thrombotic Syndrome).9 Sample

14. Anticoagulation alone… …is not enough.

15. Why remove the Clot? • Improve quality of life. • Preserve valve function and decrease post thrombotic syndrome (PTS)

16. Post Thrombotic Syndrome Sequelae PTS has a lower QOL score than conditions such as chronic lung disease and angina6

17. Clinical Studies • AbuRahma, Ali et al. (2001) Iliofemoral Deep Vein Thrombosis: Conventional Therapy Lysis and Percutaneous Transluninal Angioplasty and Stenting. • 51 consecutive iliofemoral DVT patients at West Virginia University • 33 treated with anticoagulation alone were 3% patent at one month and 30% symptom free at 1 year and 2 PEs occurred • 18 treated with CDT +/- PTV and stent were 89% patent at one month and 83% symptom free at one year with no PEs • No mortality difference

18. Clinical Studies • Elsharawy, M. and Elzayat, E. (2002) Early Results of Thrombolysis vs Anticoagulation in Iliofemoral Venous Thrombosis. • 35 patients were randomized into anticoagulation alone (17) or thrombolysis(18) groups • 12% of patients treated with anticoagulation alone were patent at six months and 41% had signs of venous reflux • 72% of patients treated with thrombolysis were patent and only 11% had signs of venous reflux

19. Outcome Measures after Iliofemoral DVT LysisClinical Study Results: Villalta Score Vs. Percent Lysis 42 patients underwent catheter directed thrombolysis and/or pharmacomechanical thrombolysis. The percent of lysis was evaluated and patients were divided into 2 groups. Mean follow-up interval was 14 months. Greater clot lysis = less PTS Grewal, P. et al. Quantity of clot lysed after catheter-directed thrombolysis for iliofemoral deep venous thrombosis correlates with postt-hrombotic morbidity. J Vasc Surg. 2010 May;51(5):1209-14

20. Interventional Options • Catheter directed lytics. • EKOS catheter. • Angiojet. • Trellis Pharmaco-mechanical thrombectomy.

21. Isolation + Pharmacomechanical Thrombolysis (Isolated PMT) • Isolated Pharmacomechanical Thrombolysis Treatments (Isolated PMT) • Thrombus isolated between occluding balloons • Lytic isolated between occluding balloons • Reduction in thrombolytic dosing • Aspiration of thrombus and lytic • Single setting thrombus removal • No reported major bleeding • Reduces/eliminates ICU time Pharmacomechanical Thrombolysis Treatments (PMT) • Thrombolytic infusion with mechanical energy • Dissolves and macerates thrombus • Reduces the thrombolytic dose & time

22. Details of Procedure • Done in a endovascular suite. • Prone position (popliteal vein approach). • Percutaneous via 8 French Sheath. • General vs. local with sedation (patient preference).

23. Prone Positioning

24. US of popliteal Vein

26. Trellis Device

27. Isolated Pharmacomechanical Thrombolysis Catheter delivered over guidewire Thrombus isolated & targeted delivery of thrombolytic drug Single-setting treatment in 83% of cases* Isolated Pharmacomechanical Thrombolysis using the Trellis Peripheral Infusion System As presented at VEITH 11/2008 ~ 1,304 Venous Patients Commercial Registry

28. Post Op • Can be done as an outpatient. • Bedrest for 2-4 hours. • Thigh high ACE wrap for 3 days, then compression stocking. • Still need anticoagulation!!

29. Who is a Candidate?? • Anatomic • Clinical

30. Who is a candidate? • Anatomic Criteria- Proximal Thombus • Caval • Iliac vein • Femoral vein

31. Venous Anatomy

32. Clinical Criteria • Active/functional patients. • Patients with massive swelling and phlegmasia cerulea dolans approaching venous gangrene. • Tolerate anticoagulation. • Optimal outcome with acute DVT (2 weeks).

33. Post-Thrombotic Syndrome (PTS) 1. Nicolaides, et al. Int Angiol 1997; 16 (1) 3-38 2. Kahn SR, Shrler I, Julian JA, Ducruet T, Arsenault, L, Determinants and Time Course of the Postthrombotic Syndrome after Acute Deep Vein Thrombosis, Ann Intern Med. 2008; 149:698-707.

34. Post Thrombotic Syndrome (PTS) Impairs Quality of Life (QOL)

35. Time Affects Outcomes Isolated Pharmacomechanical Thrombolysis using the Trellis Peripheral Infusion System As presented at VEITH 11/2008 ~ 1,304 Venous Patients Commercial Registry

36. Isolated PMT Clinical Data1,300+ Venous Registry Isolated Pharmacomechanical Thrombolysis using the Trellis Peripheral Infusion System As presented at VEITH 11/2008 ~ 1,304 Venous Patients Commercial Registry

37. Program Development • Education, Education, Education!!!

38. Key Components • Interventionalist interested in DVT treatment. • Patient Awareness. • Primary care awareness. • ER doc awareness. • Hospital Support. • Anticoagulation Clinic.

39. Case Study • 72 year old male with recent resection of glioblastoma multiforme (GBM) presents with massive right leg swelling that had been present for 24 hours. Denied chest pain or SOB. • Venous US-extensive acute occlusive venous thrombus from ankle up to common femoral vein.

40. Treatment Plan • Initiated on Lovenox in ER. • Venogram and Trellis Mechanical Thrombectomy Planned.

41. Pre Op

42. Pre Trellis Venogram

43. Post Trellis Venogram

44. Post Op

45. Pre Op Venogram

46. Post Trellis Venogram

47. Thrombus

48. Case Study #1 • 59 year old male with history of small cell lung CA currently on chemo with 1 week history of massive leg swelling with evidence of tissue loss (venous gangrene, phlegmasia). • Currently on lovenox with leg elevated.