Aggressive endovascular management of ilio-femoral DVT. thrombotic syndrome. is the key in preventing post
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1 CACVS 2017 Aggressive endovascular management of ilio-femoral DVT is the key in preventing post thrombotic syndrome ALI AMIN MD, FACS,FACC, RVT CHIEF OF ENDOVASCULAR INTERVENTIONS READING HEALTH SYSTEM READING, PA USA /2013 Slide #1
2 Faculty Disclosure Consultant Medtronic, Boston Scientific, Cardinal Health,
3 Venous Thromboembolism (DVT & PE) >2 million Deep vein thrombosis >200,000 deaths from pulmonary embolism Even after 6 months of anticoagulation following first VTE event, risk of subsequent VTE is increased by 5-12% annually.
4 Pathophysiology Accessed February Originally published in US Pharmacist with permission of the artist Kevin A. Sommerville. May not be reproduced without permission of the artist /2013 Slide #6
5 Deep Vein Thrombosis Hematologist: view DVT as a disorder of hematology and biology. Vascular Surgeon and Interventional Radiologist: view DVT from an Anatomical and Functional perspective /2013 Slide #7
6 Ilio-Femoral DVT Endovascular Specialists: View ilio-femoral DVT as fundamentally different from physiologic considerations as well as more severe disease manifestation BUT it is rarely distinguished from other forms of DVT by other physicians /2013 Slide #8
7 Not All Clots Are Created Equal Venous Thrombosis Peripheral Arterial Thrombosis Coronary Artery Thrombosis 9
8 Post thrombotic syndrome Most physicians treat all cases of proximal DVT the same. MUST differentiate between iliofemoral DVT and infrainguinal DVT. Iliofemoral DVT Virulent post-thrombotic morbidity % of Pts with DVT 800,000/Yr cases of Post-Thrombotic Syndrome Incidence and cost burden of post-thrombotic syndrome. AU Ashrani AA, Heit JA J Thromb Thrombolysis Nov;28(4): /2013 Slide #11
9 Post Thrombotic Syndrome Chronic leg heaviness Leg aching Venous claudication Edema Venous varicosities Chronic skin changes Ulceration /2013 Slide #13
10 Iliofemoral DVT Natural History Associated with Severe Postthrombotic Morbidity! O'Donnell T Mavor GE Beyth RJ J Surg Res Br J Surg 1969 Arch Int Med /2013 Slide #14
11 Ilio-Femoral DVT Long Term Clinical Status and QOL Conclusions Venous claudication developed in almost 50% Limited ambulation in 15% Marked hemodynamic impairment Markedly reduced QOL /2013 Slide #17 Delis KT et al Ann Surg 2004;239(1):118
12 Ilio-Femoral DVT Treatment Objectives Minimize or eliminate the Embolic potential of the existing Thrombus Prevent further Thrombosis Restore Venous Patency (remove obstruction) Preserve Venous Valvular function /2013 Slide #18
13 Anticoagulation DOES Minimize or eliminate the Embolic potential of the existing Thrombus Prevent further Thrombosis DOES NOT Restore Venous Patency (remove obstruction) Preserve Venous Valvular function /2013 Slide #19
14 Post Thrombotic Syndrome (PTS) Venous Hypertension Venous Capacitance is reduced Calf pump ejection fraction is reduced /2013 Slide #20
15 Ambulatory Venous Hypertension Components Obstruction Valve incompetence /2013 Slide #22
16 Ambulatory Venous Hypertension Combination of Obstruction + Valvular Incompetence 1. Obstruction 2. Valvular Incompetence Highest Venous Pressure and most severe morbidity /2013 Slide #23
17 Indications for Endovascular Therapy Functional patient with ilio-femoral DVT No Major risk factors for the use of thrombolytic But can use Mechanical Thrombectomy Need to be anticoagulated with Heparin and Coumadin Phlegmasia Cerulea Dolens /2013 Slide #24
18 Ilio-Femoral DVT Improved Outcome with Early Resolution Randomized Trial: Iliofemoral DVT Venous Thrombectomy vs. Anticoagulation 6 mos, 5 yrs, 10 yrs) Patients randomized to thrombectomy showed: 1. Improved patency P< Lower venous pressures P< Less leg swelling P< Fewer post-thrombotic symptoms P< 0.05 Compared to anticoagulation /2013 Slide #25 Plate G, et al. JVS; 1984 Plate G, et al. Eur J Vasc Surg; 1990 Plate G, et al. Eur J Vas Endovasc Surg; 1997
19 Venous Thrombectomy Femoral Vein Exposure
20 Mangagment of Ilio-Femoral DVT Anticoagulation Surgical Thrombectomy Catheter Directed Thrombolysis PharmacoMechanical Thrombectomy
21 Combination of Mechanical Thrombectomy and Thrombolysis Combination therapy is even more Powerful Initially reduces more thrombus burden Exposes a greater area of the thrombus surface to lytic agent Decrease Dose and Infusion time for thrombolytic drugs One Retrospective study, PMT greatly reduced both time of lysis (40% reduction) and Lytic drug dose (60% reduction).
22 Endovascular Intervention 1. Access 2. Device/Techniques /2013 Slide #30
23 Access Popliteal Vein Small Saphenous vein Post Tibial Vein Contralateral Femoral vein IJ Vein /2013 Slide #31
24 Popliteal Vein /2013 Slide #32
25 Small Saphenous Vein /2013 Slide #33
26 PT Vein Access /2013 Slide #34
27 Device/ Techniques /2013 Slide #37
28 Treating DVT with AngioJet Photo courtesy of Bayer HealthCare /2013 Slide #38
29 AngioJet Power Pulse Delivery System Power Pulse Delivery Power-infuse lytic solution directly into the clot Combination of chemical and mechanical thrombolysis /2013 Slide #39
30 Solent Family AngioJet Catheters for Peripheral Vessels SOLENT Proxi - 90 cm length SOLENT Omni cm length Thrombectomy power similar to DVX Compatible with 6FR sheath and guidewire Guidewire swapability Contrast injection port Power Pulse Delivery enabled Photo courtesy of Bayer HealthCare /2013 Slide #40
31 Treating DVT: Meet the Players Trellis- PMT System Thrombus isolated between 2 occluding balloons, reducing embolization risk Local delivery of lytic allows minimal dose needed to achieve high concentration Sinusoidal wire disperses lytic, mechanically disrupts thrombus Aspiration following treatment Often requires only single treatment setting
32 Treating DVT: Meet the Players EKOS Lysis System
33 EKOS US-Assisted CDT >99 % of US energy passes through valves 3 drug delivery lumens US core wire central coolant lumen thermocouple
34 /2013 Slide #46
35 PEARL Registry Prospective, multi-center registry collecting patient history, procedural information, adjunctive treatments, outcomes and adverse events. All pts treated with AngioJet Thrombectomy catheters. Pts divided into arterial, venous & dialysis access PEARL I (January 2007 thru April 2010): Followed patients for 3 months with documentation of symptomatic improvement after rheolytic thrombectomy (with mid-length catheters). PEARL II (March 2010 thru June 2013): Followed patients outcomes through 12 months after thrombectomy using any AngioJet Catheter /14 Slide # 47
36 Registry Objectives Determine efficacy of thrombus removal from baseline to final venogram Evaluate clinical outcomes of treated patients at defined intervals of 3, 6 & 12 mos. Characterize clinical events Characterize treatment options used with the AngioJet System Estimate rate of AngioJet Thrombectomy related adverse events /14 Slide # 48
37 DVT Age From Signs/Symptoms Onset 24 Hours 18 (5%) Acute > 24 Hours and 7 Days 158 (43%) > 7 Days and 14 Days 80 (22%) 256/371 (69%) Sub Acute > 14 Days and 30 Days 68 (18%) > 30 days and 3 Months 33 (9%) Chronic > 3 Months and 6 Months 8 (2%) > 6 Months 6 (1%) 68/371 (18%) 47/371 (13%) 69% of patients report symptom onset of < 14 days /14 Slide # 51
38 PEARL Results Duration of treatment Time Period Frequency </= 6 Hrs 133 (38%) > 6 Hrs & </= 12 Hrs 37 (10%) > 12 Hrs & </= 24 Hrs 97 (27%) >24 Hrs 88 (25%) (355/371 had times recorded) 38% completed in < 6 hrs 75% completed in < 24 hrs /14 Slide # 52
39 PEARL Results # of sessions # of Sessions N(%) (34%) (53%) 3 40 (11%) >3 7 (2%) (359/371 had # sessions recorded) 87% had 2 or less sessions /14 Slide # 53
40 PEARL Results Lab Test Comparisons Analyte Pre-procedure Mean Post-procedure Mean Mean Difference* P Value Hemoglobin (N=266) < BUN (N=235) Creatinine (N=239) Wilcoxon Signed Rank Test *Paired analysis /14 Slide # 54
41 % of Treated Vessels PEARL Results Venographic Results N = 1295 vessels treated (p<0.0001) <1 Improved Unchanged Worsened /14 Slide # 55
42 % of Treated Vessels Venographic Results clot age by Sx Onset (p<0.0001) Improved Unchanged Worsened <=24 Hrs N= < Days N= Days N=306 ACUTE DVT /14 Slide # 57
43 % of Treated Vessels Venographic Results clot age by Sx Onset (p<0.0001) Days N=226 SUBACUTE Days N= CHRONIC >3 Mons N=40 Improved Unchanged Worsened /14 Slide # 58
44 % Pts Free from Rethrombosis Freedom from Rethrombosis* % 88% 84% 90 Days 180 Days 365 Days Days Post Procedure * Estimated by Kaplan Meier /14 Slide # 59
45 % Pts Maintaining Clinical Benefit Maintained Clinical Benefit* % 82% 78% 90 Days 180 Days 365 Days Days Post Procedure * Estimated by Kaplan Meier /14 Slide # 60
46 QOL Mean Scores SF 12 QOL (PII Only) Baseline N=186 3 Mon N=173 48,5 48,1 48, ,5 42,8 6 Mon N= Mon N=151 Physical Mental There are statistically significant improvements measured by the physical (p<0.0001) and mental (p<0.0001) components. The pretreatment physical scores differ significantly from the 3, 6 & 12 month follow ups /14 Slide # 61
47 PEARL Comparison Treatment of LE DVT PEARL Venous Registry* CDT CaVenT** # of Patients # of Sites Prior DVT 40% 31% 10% 9% Primary Treatment STD AngioJet Thrombectomy With or Without PPS/RL CDT CDT LMWH Stent Placement 35% 33% 17% NA Primary access Popliteal Popliteal Popliteal NA Gender Male=57%; Female=43% Male= 48%; Female=52% Male=64%; Female=36% Male=62%; Female=38% Age (mean) 52.2 yrs 47.5 yrs 53.3 yrs 50.0 yrs Treatment Location Iliofemoral femoral pop Iliofemoral femoral pop CFV or iliofemoral Limbs Involved * Mewissen MW, Seabrook GR. Radiology 1999:211:39-49 **Enden, Haig Y.. Lancet 2012:379:31-38 Left=62%; Right=38% Left=61%; Right=39% Left=60%; Right=40% Left=62%; Right=38% /14 Slide # 63
48 PEARL Comparison Treatment of LE DVT Onset of DVT Sympto ms PEARL Venous Registry* CDT CaVenT** Acute 67% ( 14 days) 66% ( 10 Days ) 100% 21 days Chronic 33% (>14 days) 16% (>10 Days ) NA Acute & Chronic NA 19% NA STD Primary Lytic TPA Urokinase TPA NA CDT Drip Times (mean) 17 hrs 48 hrs 57.6 hrs (2.4 days) NA Procedure Times CDT (N=29) CDT+PPS/RL (N=172) PPS/RL (N=115) Bleeding Complications * Mewissen MW, Seabrook GR. Radiology 1999:211:39-49 **Enden, Haig Y.. Lancet 2012:379: hrs NA NA NA 22.0 hrs NA NA NA 2.0 hrs NA NA NA 5% (major & minor combined) 11% (major); 16% (minor) 22% (major & minor combined) 0% /14 Slide # 64
49 PEARL Comparison Treatment of LE DVT Overall % Thrombus Removal By Lytic Groups: % thrombus Removal CDT (N=28) CDT+PPS/R L (N=167) PPS/RL (N=113) Acute: % Thrombus Removal Chronic: % Thrombus Removal Acute & Chronic: % Thrombus Removal Primary Patency Freedom from Rethrombosis PEARL Venous Registry* CDT CaVenT** STD 96% 83% 89% NA 93% NA NA 97% NA NA 95% NA NA 97% 86% 89% 95% 68% NA NA 76% NA NA 6 Mon= 87%; 12 Mon=83% 6 Mon=65%; 12 Mon=60% 6 Mon = 65.9% 6 Mon = 47.4% NA NA NA * Mewissen MW, Seabrook GR. Radiology 1999:211:39-49 **Enden, Haig Y.. Lancet 2012:379: /14 Slide # 65
50 Summary: Acute Ilio-Femoral DVT Medical management is associated with higher PTS compare to endovascular management There is increasing evidence that early thrombus resolution with endovascular intervention is associated with improved outcome Pharmacomechanical decreases procedure time, decrease amount of thrombolytic used
51 Pull out, Betty! Pull out!...you ve hit an artery!
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