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Rocky Mountain ACP Internal Medicine Conference November 22, 2012 Brian Wirzba, MD, FRCPC, FACP.

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Presentation on theme: "Rocky Mountain ACP Internal Medicine Conference November 22, 2012 Brian Wirzba, MD, FRCPC, FACP."— Presentation transcript:

1 Rocky Mountain ACP Internal Medicine Conference November 22, 2012 Brian Wirzba, MD, FRCPC, FACP

2 No financial disclosures or conflicts of interest for this presentation I have received honoraria for presentations and advisory panel work in the area of osteoporosis from Amgen, Eli Lilly and Norvartis in the last 2 years.

3  By the end of this short snapper the audience will have:  Have a better understanding of the current pharmomechanical therapies (PMT) available for treatment of large proximal DVTs.  Be aware of the published data to support PMT for large proximal DVTs (and the limitations of this data).

4  68 y.o. presented to the GNH ER with a 10d Hx of L leg swelling and 2d of pain in the upper thigh.  She had traveled to Portugal 1 month ago (12hr flight) followed by transient bilateral leg swelling for 2d (resolved)  No history of malignancy or symptoms of occult malignancy  No family Hx of VTE, no other immobility or risks  HRT age  PHx – generally healthy, remote hysterectomy, normal yearly labs  Venous Doppler – extensive DVT in L Leg from calf to pelvis in the L iliac vein  Patient started on LMWH and given 5mg Warfarin

5  Given clot into the pelvis a CT Abdomen/Pelvis was ordered  “Extensive thrombosis involving the entire L common and external and internal iliac veins, associated edema and enlargment of the L iliopsoas and piriformis muscles related to the obstruction. The thrombus superiorly extends to the level of the aortic bifurcation and May-Thurner syndrome is suspected. No neoplasm evident.”

6  Proximal DVT’s have generally been treated with anticoagulation alone:  Unfractionated or Low Molecular Weight Heparin (UFH/LMWH)  Warfarin with a target INR 2-3 for 3-12 months  Early trials with systemic thrombolysis (primarily Streptokinase) showed reduced thrombus but had a 3x increase in bleed risk Am J Med 1984;76:  Trials have generally focused on Mortality, Hospitalization and Bleeding, but what about Post-Phlebitic Syndrome?

7  PTS is the end stage sequelae of DVT resulting from inadequate treatment of the acute DVT or from chronic subclinical DVT.  When acute clot does not resolve, the clot hardens leading to chronic obstruction.  There is also venous valve damage, calf muscle dysfunction and inflammation  Venous Hypertension  Venous Valvular Reflux Br J Haematol. 2009;145:

8  PTS is thought to occur to some degree in 20-50% of patients within 2 years of a DVT Chest 2012;141: J Thromb Haemost. 2005;3: Ann Intern Med. 2008;149:  In general after any lower extremity DVT:   30-60% of patients have no residual symptoms   30-50% will have some degree of PTS   5-10% will have severe PTS  PTS usually develops within 6 months but can up to 2 years after the acute DVT.  15% of patients with upper extremity DVT develop PTS Thrombosis Research 2006; 117:

9  387 patients (347 seen at 4mo) with acute symptomatic DVT in 8 Canadian hospitals treated with routine care Ann Intern Med 2008;149: % 56.8% 85.9% 14.1% 4.3% 4.9% QOL Scores for patients with severe PTS are similar to patients with Chronic Angina, Cancer and Severe CHF

10  Previous DVT (especially if ipsilateral 5-10x)  Signs of Post-Thrombotic Syndrome at 1 month (4x)  Extensive or More Proximal DVT (2x)  Obese (2x)  “may” be increased if inadequate initial anticoagulation  Older Age – not consistent  Female – not consistent  NOT influenced by cause of DVT, intensity or duration of anticoagulation

11  “Iliofemoral DVT patients have the largest thrombus burden and up to 75% have chronic painful edema with 40% having venous claudication when treated with anticoagulation therapy alone.” Eur J Vasc Surg 1990;4:43-48 Ann Surg 204;239: J Surg Res 1977;22: JAMA 1983;250:1289

12  Systemic Thrombolysis  Flow Directed Thrombolysis (Pedal IV infusion)  Surgical Interventions:  Vein Dilatation and Stenting, Venous Bypass Grafting, Endophlebectomy with reconstruction, Valve reconstruction & transplant, interruption of perforating veins.  CDT – Catheter-directed Intrathrombus Thrombolysis  PMT – Percutaneous Mechanical Thrombectomy  PCDT – Pharmomechanical Catheter Directed Thrombolysis

13  Anticoag alone is inadequate  Big clots lead to worse Sx  Early clot dissolution is good  CDT can remove clot  CDT provides fast relief of Sx  CDT uses less thrombolytic  CDT has fewer bleeding SE  Society of Interventional Radiology Position Statement:  “The published literature suggests that adjunctive CDT plus anticoagulant therapy is an acceptable initial treatment strategy for many patients with acute iliofemoral DVT” J Vasc Interv Radiol 2006;17:

14  Hydrodynamic or Rheolytic thrombectomy catheter  Based on industrial technology  Multiple generations since 1992 introduction

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19  Adjunctive CDT has been shown effective in:  90% thrombolysis rate in patients with iliofemoral DVT Vasc Interv Radiol 2006;17: Radiology 1999;211:39-49  Reducing anaesthesia, incision issues, and prolonged recovery (compared to surgical thrombectomy) Eur J Vasc Surg 1990;4: Semin Vasc Surg 1996;9:34-45  In the National Venous Registry:  Patients treated with short term thrombosis (<10 days) had better outcomes than those with older clot  Correction of underlying venous lesions after successful thrombolysis (usually with intravascular stenting) appeared to be beneficial Radiology 1999;211:39

20  Open label, RCT from Norway with 209 patients looking at CDT vs. Anticoagulation alone over 2 years  Mean duration of CDT was 2.4 days (max 6d) with 43/90 having complete lysis, 37 having partial, and 10 unsuccessful lysis including 2 technical failures.  23 had angioplasty, 15 had venous stents, 1 had thrombus aspiration and IVC filter (Angiojet)

21  20 had bleeding complications in CDT but only 3 major and 5 clinically relevant. 4 had non-bleeding SE.  There was no difference in recurrent DVT, PE, Death NNT 7

22 No direct comparisons b/w old and new technologies but the rates of bleeding have dropped by ½ (to about 4.8%) perhaps due to better patient selection.  Only 22% of patients with PCDT need only 1 treatment  Most need 2 or more treatments and infusion time  There is a reduced treatment time and tPA dose  No decrease in LOS or ICU LOS J Vasc Surg 2008;48:1532

23  Systemic Thrombolysis  Flow Directed Thrombolysis (Pedal IV infusion)  Surgical Interventions:  Vein Dilatation and Stenting, Venous Bypass Grafting, Endophlebectomy with reconstruction, Valve reconstruction & transplant, interruption of perforating veins.  CDT – Catheter-directed Intrathrombus Thrombolysis  PMT – Percutaneous Mechanical Thrombectomy  PCDT – Pharmomechanical Catheter Directed Thrombolysis NOT recommended over routine Anticoagulation in most patients ACCP 2012 Guidelines Compression Stockings ARE recommended for all Acute Symptomatic Leg DVT’s (Grade 2B)

24  ACCP 2012 Guidelines Section 2.9  2.9 – In patients with Acute Proximal DVT of the leg, we suggest anticoagulation therapy alone over catheter directed thrombolysis (CDT) [Grade 2c]  Remarks – Patients who are most likely to benefit from CDT, who attach a high value to prevention of postthrombotic syndrome (PTS), and a lower value to the initial complexity, cost, and risk of bleeding with CDT, are likely to choose CDT over anticoagulation alone. Chest. 2012, 141(2), Supp p21

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26 Improved Patency Improved QOL Decreased PTS 2-4d ICU stay 10-20% bleed risk Cost Multiple programs involved Moving an outpatient condition into the inpatient world (again)

27  Phlegmasia cerulea dolens  Acute IVC thrombosis  Acute Iliofemoral DVT  Low bleeding risk  > 1 year life expectancy  <70 year old age  Good Functional Status & Ambulatory  Does not have PTS already  Can tolerate procedure  Not pregnant  No Contraindication to tPA

28  Given clot into the pelvis a CT Abdomen/Pelvis was ordered  “Extensive thrombosis involving the entire L common and external and internal iliac veins, associated edema and enlargment of the L iliopsoas and piriformis muscles related to the obstruction. The thrombus superiorly extends to the level of the aortic bifurcation and May-Thurner syndrome is suspected. No neoplasm evident.”

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30  NIH funded, multicenter, randomized, open-label, assessor-blinded controlled clinical trial  692 patients in 28 centers  Patients followed for 2 years 1.Does PCDT prevent PTS? 2.Does PCDT improve QOL? 3.Is PCDT safe enough? 4.Is PCDT cost effective? 5.What is the mechanism by which PCDT prevents PTS?

31  What about femoropopliteal DVT?  Smaller margin for potential benefit  What about subacute/chronic DVT  Doesn’t work as well  Valvular damage already done  Need for IVC Filter?  No good data. Manufacturers have recommended it.  Balloon Angioplasty/Stents  Iliocaval venous stenosis – eg. May-Thurner Syndrome  ASA long term, Clopidegril for 8 weeks  True Cost

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34  359 consecutive DVTs in 7 Canadian hospitals  Over 4 months there was generally an improvement in QOL scores however:  1/3 patients had worsening QOL during followup  This worsening correlated with worsening PTS scoring Arch Intern Med 2005;165:  Venous Ulcers lead to >2 million work days lost and $300M in the US annually J Vasc Surg 2001;33: J Am Acad Dermatol 1994;31:49-53

35 Thrombosis Interest Group of Canada PTS Guideline, 2009 Br J Haematol. 2009;145:

36  After looking up May-Thurner Syndrome – called vascular surgery for opinion – in OR  Finally at 5pm on a Friday what else is there to do but to call the next vascular surgeon on call.  Suggested calling Hematology at UAH “as there is a study going on using thrombolytics”  Called the Hematologist (not on call) – “This is the standard of care!! No need to do it at the UAH. Call the radiologist on call for interventional at the UAH.  “Absolutely this is the standard of care!! We will do it this weekend at the GNH. Have you ever done them?”  “By the way you need to arrange an ICU bed.”

37  Saturday am – radiologist from UAH on call for IR performed  LIMITED US WITH INTERVENTIONAL  IVC FILTER INSERTION, INCLUDES VENACAVAGRAM  THROMBECTOMY USING A MECHANICAL DEVICE THROMBOLYSIS BASE + 30 MIN INFUSION (aka Trellis)  Saturday pm – repeat venogram – residual thrombus so given tPA overnight at and infusion of 0.5mg/hr

38  Sunday am – tPA discontinued due to low fibrinogen level  Radiologist from UAH on call for IR performed:  ANGIOPLASTY PERIPHERAL – of common iliac stenosis  PERIPHERAL VASCULAR STENT PLACEMENT – into common iliac  SELECTIVE ABDOMINAL/PELVIC VENOGRAM – failed attempt to remove IVC filter  PHARMACEUTICAL INFUSION CATHETER  Tuesday am – failed attempt at IVC filter removal from the R side

39  Wednesday – patient had IVC filter removed with a bilateral catheter (double IR) approach through the R IJ and the R CFV  Rx with IV UFH  LMWH  Transitioned to Warfarin x 6mo  Indefinite ASA  OT saw patient for compression  (-) Hypercoaguable workup  Patient stable at 1 and 4mo f/u

40  Short term treatment with SC LMWH, IV UFH, monitored SC UFH, Fixed dose SC UFH, SC Fondaparinux [all Grade 1a]  Treat with short term agent for at least 5 days and until INR >2.0 for 24hrs [Grade 1c]  Initiate Warfarin on the first day of treatment [Grade 1a]  Standard anticoagulation prevents thrombus extension and embolization to the pulmonary arteries but does not directly lyse the acute thrombus Thrombosis Interest Group of Canada PTS Guideline, 2009

41  66% RRR in recanalization of thrombosed veins Am J Med 2011;124:  81% RRR in venous ulceration at 3 mo (0.5 vs. 4.1%) Am J Med 2009;122:  Prolonged LMWH (3mo.) has been shown to reduce PTS vs. Warfarin Chest. 2008;133:454S-545S

42  ACCP 2008 Guidelines Section 3.1  – For a patient who has had a symptomatic proximal DVT, we recommend the use of an elastic compression stocking with an ankle pressure gradient of 30-40mmHg if feasible. Compression therapy, which may include use of bandages acutely, should be started as soon as feasible after starting anticoagulation therapy and should be continued for a minimum of 2 years, and longer if patients have symptoms of PTS. [Grade 1c] Ann Intern Med. 2004;141: Chest. 2008;133:454S-545S  54% RRR with the use of ECS for 2 years Cochrane Database of Systematic Reviews 2004;1:2004

43  ACCP 2008 Guidelines Section 3.2  – For a patients with severe edema of the leg due to PTS, we suggest a course of intermittent pneumatic compression. [Grade 2b]  – For a patients with mild edema of the leg due to PTS, we suggest the use of elastic compression stockings. [Grade 2c]  – In patients with venous ulcers resistant to healing with wound care and compression we suggest the addition of intermittent pneumatic compression. [Grade 2b] Chest. 2008;133:454S-545S

44 Thrombosis Interest Group of Canada PTS Guideline, 2009  No strong evidence to support surgical interventions (valvuloplasty)  EVLT (Endovenous Laser Treatment) can be used for superficial varicosities – primarily cosmetic, not useful in the most severe cases NO CURE

45  Femoropopliteal veins with DVT:  Are recanalized in 50% of patients at 3mo  Are recanalized in 90% of patients at 12mo  Have valvular reflux evident on Doppler at 1mo in 40% of patients J Vasc Surg 1992;15: J Vasc Surg 1993;18:  Iliofemoral veins with DVT:  Are recanalized in only 5% of patients with anticoagulation alone Ann Surg 2004;239: Ann Intern Med 2008;149:

46  Cochrane Review (2004 & 2007):  12 studies reviewed  Significant reduction of clot lysis (RR 24% early, 37% late)  Similar effects seen in the degree of improvement of patency  Reduced Post Thrombotic Syndrome (RR 66%)  Reduced leg ulceration (RR 53%) – hindered by low numbers  No mortality benefit  No clear effect on PE or recurrent DVT  Increased bleeding (RR 173%)  Increased Stroke Risk (RR 170%)  This did seem to improve with more recent trials

47 19 studies – heterogeneous designs Significant lysis observed in 79% of the 945 limbs treated Of 98 patients with iliofemoral DVT treated with CDT (n 68) vs. anticoagulation alone (n=30) the QOL was better and correlated with the degree of lysis


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