Advances in Percutaneous Intervention William C. Dixon IV, MD, FACC, FSCAI

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1 Acute and Chronic Venous Disease Advances in Percutaneous Intervention William C. Dixon IV, MD, FACC, FSCAI

2 Outline Chronic venous insufficiency Acute DVT Intervention Chronic DVT Intervention

3 Chronic Venous Insufficiency (CVI) Pathophysiology Clinical evaluation Role of ultrasound Endovascular therapy

4

5 Pathophysiology of CVI Primary Secondary Vein Degeneration Valve Damage/Obstruction Ambulatory Venous Hypertension Microcirculatory Changes Skin Changes & Ulceration

6 Primary Reflux Degenerative NOT descending hemodynamic process A multicentric (systemic) disease Wall degeneration precedes varicose changes Smooth muscle fragmentation Increased collagen Vein Wall Degeneration Venous Dilation Coaptation Failure Reflux Decrease elastin Loss of vascular reactivity

7 Secondary Reflux Markel A, J Vasc Surg limbs (103 patients) with 1 st episode of DVT Serial U/S follow-up Days after DVT * Saphenous reflux also present in 25% or limbs

8 The Pathophysiology of CVD Reflux & Obstruction Leukocyte Activation, Adhesion, Migration Endothelial Activation Increased Permeability Decreased Resistance

9 Leukocyte Activation The Origin of Advanced CVI Activated leukocytes migrate extravascularly Release of toxic oxygen metabolites, cytokines, & proteases TGFß Primary mediator of dermal fibrosis Macrophage / fibroblast recruitment Fibroblast production of extracellular matrix Altered tissue remodeling Imbalanced MMP-2 / TIMP Altered Tissue Remodeling MMPs TIMP TGFß

10 Summary Etiology of CVD 1º disease - A degenerative disease of the vein wall 2º disease - A combination of reflux and obstruction Anatomy is important Combined patterns of reflux Superficial veins Distal deep veins Iliac venous obstruction Manifestations of venous htn mediated by the microcirculation Endothelial activation Leukocyte activation

11 Clinical Evaluation-symptoms

12 Clinical Evaluationsigns Clinical severity Etiology Anatomy Pathophysiology

13 C1 C2 C3 C4 C5 C6

14 Role of venous ultrasound Confirm patency of the deep system Evaluate superficial anatomy -Size -Tributaries Quantify reflux Post-ablation evaluation

15 Reflux on ultrasound Forward flow Backward flow

16 Treatment Compression Vein stripping Venous ligation Endovascular therapy (EVTA) Radiofrequency ablation (RFA) Laser ablation

17

18 Laser vs RFA

19 RFA

20 RFA

21 RFA

22 RFA

23 Baseline 6 months post-rfa

24 Deep Vein Thrombosis

25 Deep Vein Thrombosis In the U.S. alone, 600,000 new DVT cases are diagnosed each year Aside from the acute changes from the thrombotic event, patients are at high risk of developing postthrombotic syndrome (PTS) and pulmomary embolism (PE)

26 Deep Vein Thrombosis by the numbers 1/3 proportion of patients with lower limb DVT who will likely develop an embolus, causing life-threatening PE 10-30% - patients will die within one month of diagnosis of DVT/PE 1/3 proportion of DVT/PE patients who will experience recurrence within 10 years 25%-70% - percentage of acute DVT patients who develop long-term complications, such as PTS 1 in 100 incidence of people over 80 years old affected by DVT/PE 5-8% - proportion of the U.S. population with one of several genetic risk factors for thrombosis

27 Long-term Health Complications of DVT: Post-Thrombotic Syndrome Post-thrombotic syndrome (PTS) may result in: Chronic pain 1 Swelling 1 Skin ulceration secondary to post-phlebitis syndrome 1 Chronic condition in 30% to 75% of DVT patients within 2 years 2 Irreversible damage to veins & valves Significant and lasting impact on quality of life Nearly 90% of patients are unable to work due to leg symptoms 10 years after iliofemoral DVT 3 1. Geerts et al. Chest. 2004;126(suppl):338S-400S 2. Parikh et al JVIR ; Kahn SR, Ginsberg JS. Relationship Between Deep Venous Thrombosis and the Post thrombotic Syndrome. Arch Intern Med 2004; 164:17 26.

28 How Post Thrombotic Syndrome Develops Post DVT residual thrombus leads to valvular damage Residual thrombus propagates until symptomatic again Venous insufficiency, hypertension, and reflux contribute to stasis and re-thrombosis Post Thrombotic Syndrome develops Impairs a patient s activities of daily living, work performance and treatment satisfaction (QOL)

29

30 Long-term Health Complications of DVT: Pulmonary Embolism PE: most preventable cause of in-hospital death 1 70%-80% of fatal PEs occur in nonsurgical patients 2 Improved treatment might have a minimal impact on the number of deaths, more effective prevention of recurrent PE would represent the greatest opportunity to prevent fatal recurrent PE 1 The first manifestation of DVT/PE may be fatal PE 3 1. Clinical Syndromes and Clinical Outcome in Patients With Pulmonary Embolism: Findings From the RIETE Registry - CHEST 2006 Lobo et al 2. Geerts WH, et al. Chest. 2008;133:381S-453S. 3. Geerts et al. Chest. 2004;126(suppl):338S-400S

31 Conventional modes of therapy are inadequate Historical study on anticoagulated DVT patients reported poor outcomes, including 95% valvular dysfunction, 90% ambulatory venous hypertension, 70% obstructive iliac vein lesion, 50% calf muscle pump dysfunction at 5 year follow up if thrombus resolution is not achieved within days, the ability to restore venous patency and preserve valve function is compromised, leading to a significantly increased rate of rethrombosis

32 Anticoagulation Alone... does prevent clot propagation. does reduce risk of pulmonary embolism. But, it typically does NOT resolve clot. does NOT rapidly resolve symptoms. does NOT prevent PTS (Post Thrombotic Syndrome).

33 Evolution of DVT Treatment Options Anticoagulation Therapy Systemic Thrombolysis Catheter Directed Thrombolysis Pharmacomechanical Thrombolysis Isolated Pharmacomechanical Thrombolysis

34 Despite treatment progress the majority of DVT patients are still being treated with anticoagulation therapy alone

35

36 Catheter-Directed Thrombolysis for Iliofemoral DVT Patency Randomized Studies Elsharawy et al Eur J Vasc Endovasc Surg 2002; 24:209 (N=35) (6 month) Lysis Anticoag P-Value 72% 12% <0.001 Enden et al J Thromb Haemost 2009; 7:1268 (N=103) (6 month) Plate et al Eur J Vasc Endovasc Surg 1997; 14:367 (N=30) (10 Years) 64% 36% % 41% <0.05

37 Catheter-Directed Thrombolysis for Iliofemoral DVT Normal Valve Function (6 month) Randomized Studies Elsharawy et al Eur J Vasc Endovasc Surg 2002; 24:209 (N=35) Enden et al J Thromb Haemost 2009; 7:1268 (N=103) Lysis Anticoag P-Value 89% 59% % 34% 0.53 *Reflux not present in occluded veins

38

39 Ultrasound Accelerated Thrombolysis provides greater clot clearance than CDT Parikh et al. J Vasc Interv Radiol Apr;19(4): % 70% 70% Complete clot lysis Partial clot lysis No clot lysis 60% 50% 40% 30% 20% 10% 31% 52% 38% 45% 17% 18% 21% 9% 0% National Venous Registry1 N=287 NVR registry of DVT patients treated with CDT Cleveland Clinic Foundation Retrospective Data N=80 1. Mewissen, et al. Radiology Apr;211(1): Parikh et al. J Vasc Interv Radiol Apr;19(4): EKOS N=53 2

40 2004 ACCP DVT Intervention Guidelines 2004 ACCP guidelines recommended AGAINST thrombolytics for DVT, except for in the use of limb salvage. ACCP recommend in patients with DVT against the regular use of catheter-directed thrombolysis. In addition, the ACCP suggested that this treatment should only be considered in patients that are requiring limb salvage.

41 2008 ACCP DVT Intervention Guidelines Significant Changes in 2008 for DVT intervention. Thrombolytics are NOW SUGGESTED for acute, proximal DVT. In the patient population with extensive acute proximal DVT* (eg, iliofemoral DVT, symptoms for < 14 days, good functional status, life expectancy of 1 year) who have a low bleeding risk, catheter-directed thrombolysis (CDT) is suggested by the ACCP to reduce acute symptoms and post-thrombotic morbidity* in settings where the right expertise and resources are available. It is also suggested by the ACCP that Pharmacomechanical thrombolysis should be considered over CDT alone in order to shorten treatment time* in settings where the right expertise and resources are available. When successful CDT has been completed in patients with acute DVT, the recommendation is to utilize the same intensity and duration of anticoagulation therapy as similar to those who do not receive thrombolysis.

42 2011 American Heart Association Guidelines Summary of Recommendations for Endovascular Thrombolysis and Surgical Venous Thrombectomy For I liofemoral DV T patients with a low risk of bleeding, C atheter Directed T hrombolysis (C DT ), or Pharmacomechanical C atheter Directed T hrombolysis (PC DT ), is a reasonable first-line of treatment to achieve more rapid relief of current symptoms and to prevent Post-T hrombotic Syndrome (PT S) despite anticoagulation. B ecause PC DT generally reduces the amount of patient exposure to the thrombolytic drug, selecting PC DT over C DT may be reasonable in the majority of patients receiving endovascular thrombolysis. H igh risk patients of bleeding and with C hronic DV T (>21 days) should not be given PCDT or CDT.

43 Algorithm for treatment of acute iliofemoral DVT

44

45 LLE DVT

46 LUE DVT

47 Chronic DVT

48 Questions?

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