# Presentation: 075713

## AGGRESSIVE THERAPIES

**Thomas W. Wakefield MD**
**S. Martin Lindenauer Professor**
**Section of Vascular Surgery**
**University of Michigan**

## Aggressive Therapies

**Goals of Therapy for Venous Thromboembolism (VTE)**** **
**	****	****1.****	****Prevent Extension or Recurrence of Deep Venous ****	****	****Thrombosis (DVT) **
**	****	****2.****	****Prevent Pulmonary Embolism (PE)**
**	****	****3. ****	****Minimize Early and Late Squeal of the Thrombosis**
**Anticoagulants Accomplish #1, #2**
**Anticoagulants in General do not Accomplish #3**

## Aggressive Therapies

**Thrombi are Dynamic**** **
**Organize, Fibrose, Recanalize, Embolize; Stimulate **
**Inflammatory Response in the Vein Wall and Valve**
**Approximately Half will Completely Recanalize within 6 to 9 months**
**Symptomatic Recurrent Thromboembolic Events in 5% to 15%**
**Occult Events even more Prominent (up to 50%)**
**Thrombus Propagation in 26% to 38% by Serial Ultrasound scans**

**Krupski et al, J Vasc Surg 125:467-475, 1990; Caps et al, Vasc Med 4:9-14, 1999; **
**Meissner et al, J Vasc Surg 22:558-567, 1995**

## Post-Thrombotic Syndrome (CVI)
Varicose Veins to Severe Pain, Swelling, and Ulceration

23% after 2 years
28% after 5 years
29% after 8 years

Especially with Ipsilateral Recurrent DVT

Prandoni et al, Ann Intern Med; 125:1-7, 1996

**Varicose Veins to Severe Pain, Swelling, and Ulceration**
**23% after 2 years**
**28% after 5 years**
**29% after 8 years**
**Especially with Ipsilateral Recurrent DVT**
**Prandoni et al, Ann Intern Med; 125:1-7, 1996**

## Aggressive Therapies

**Thrombus Removal by:**
**Thrombolytic Medication**
**Mechanical Devices**
**Pharmacomechanical Approaches**
**Operative Thrombectomy**

## “Thrombolytic therapy remains controversial 

**particularly due to the risk of bleeding **
**and is not indicated for the routine**
**treatment of VTE”**
**Russell Hull, PVS-V, adpated from Hirsh J, et al., **
**Seventh ACCP Conference on Antithrombotic Therapy **
**and Thrombolytic Therapy.  Chest 126: 172S, 2004**

## Thrombectomy (n31) vs Anticoagulation (n32)
Clinical Success - 6 months
40% vs 7% Asymptomatic
76% vs 35% Iliofemoral Patency
52% vs 26% Femoropopliteal Patency

Thrombectomy (n13) vs Anticoagulation (n17)
Follow-up - 10 years
83% vs 41% Patency
78% vs 43% No Popliteal Reflux

Plate et al, Eur J Vasc Endovasc Surg 14:367-374, 1997
Eklof & Kistner, Sem in Vasc Surg 9:34-45, 1996

**Clinical Success - 6 months**
**40%**** vs 7% Asymptomatic**
**76%**** vs 35% Iliofemoral Patency**
**52%**** vs 26% Femoropopliteal Patency**
**Thrombectomy (n13) vs Anticoagulation (n17)**
**Follow-up - 10 years**
**83%**** vs 41% Patency**
**78%**** vs 43% No Popliteal Reflux**
**Plate et al, Eur J Vasc Endovasc Surg 14:367-374, 1997**
**Eklof & Kistner, Sem in Vasc Surg 9:34-45, 1996**

## Comerota AJ, PVS-V, 2005

**Comerota AJ, PVS-V, 2005**

## Quality of Life Measures

**Mean scale scores comparing patients who had either partial or complete lysis with lytic therapy vs. patients who had heparin treatment**** **

|    Scale item* | Complete + partial 
(mean ± SE) | Heparin 
(mean ± SE) | P value |
| --- | --- | --- | --- |
| Initial contact mean, 16 months | N = 43 | N = 30 |  |
| Health Utilities Index | 0.83 ± 0.03 | 0.74 ± 0.03 | .032 |
| Health interference | 75.01 ± 3.98 | 67.29 ± 4.78 | .24 |
| Role functioning physical | 75.68 ± 4.57 | 56.59 ± 5.56 | .013 |
| Treatment satisfaction | 86.59 ± 4.25 | 81.72 ± 5.18 | .49 |
| Stigma | 85.98 ± 4.11 | 71.32 ± 5.00 | .033 |
| Health distress | 82.48 ± 4.04 | 64.11 ± 4.91 | .007 |
| Overall symptoms | 78.55 ± 3.44 | 55.56 ± 4.19 | .001 |
| Follow-up 22 months | N = 32 | N = 13 |  |
| Health Utilities Index | 0.71 ± 0.04 | 0.73 ± 0.07 | .77 |
| Health interference | 68.25 ± 5.38 | 66.11 ± 8.63 | .84 |
| Role functioning physical | 68.52 ± 5.14 | 56.07 ± 8.09 | .23 |
| Stigma | 90.48 ± 4.11 | 69.50 ± 6.71 | .014 |
| Health distress | 80.25 ± 4.19 | 56.32 ± 6.85 | .006 |
| Overall symptoms | 74.11 ± 3.87 | 50.56 ± 6.66 | .006 |
|                        Comerota et al, J Vasc Surg 32: 130-137, 2000

Adjusted for propensity scores (education, marital status, age) and number of days since hospitalization.*Higher scores represent higher functioning/less interference/fewer symptoms/less distress. |  |  |  |

## Need Level 1 Evidence Comparing Standard 

**Anticoagulation to Thrombus Dissolution **
**using Thrombolysis and/or **
**Venous Thrombectomy**
**We know all DVTs are Not Alike!!!**

## Mechanical Devices

**Catheters (Venturi Effect)**
**Mechanical Catheters with Balloons**
** **
**Ultrasound**** **

## Early Removal of Thrombus Conveys Significant Benefits

**The Earlier the Removal, the Better the Outcome**
**However, the Therapy is Complicated with Bleeding risk**
**and the Value of such Therapy is Not Defined**
**National Organizations have Identified the **
**Need for Studies**
**Society for Interventional Radiology **
**American Venous Forum**

## Pulmonary Embolism

**Thrombolytic Therapy/Embolectomy for Cardiogenic Shock**
**? Right Ventricular Dysfunction without Hemodynamic Instability**
**Thrombolytics + Anticoagulants vs. Anticoagulants for Submassive PE **
**Thrombolytics Reduced Need to Escalate Therapy**

**Goldhaber SZ,  Lancet 363: 1295-1305, 2004**
**Konstantinides S et al, N Eng J Med 347:1143-1150, 2002**

## Pulmonary Embolectomy

**Useful in Situations of Massive PE with**
**Thrombolysis Failure (approx 8%)**
**Lowers Mortality Rate (p = 0.07)**
**Lowers Recurrent PE rate (p<.05)**
**Lowers Fatal Bleeding Episodes**

**Meneveau N et al,  Chest 129:1043-1050, 2006**
**Davidson B & Karny-Jones R, Chest 129:839-840, 2006**

## IVC Filters

**Indications**
**Complication of Anticoagulation**
**Contraindication to Anticoagulation**
**Failure of Anticoagulation**
**VTE Prophylaxis**
**Protection from PE >95% when using wire-based filters over 20 yrs**
**Filters Placed Infrarenal, Suprarenal, even in SVC**
**Retrievable Filters (3 Types) Now Becoming Predominant**
**If Left to become Permanent, Long-term Fate Unknown**
**Percutaneous Technique**
**Fluoroscopy, Ultrasound (External, IVUS) **

**Greenfield & Proctor,  Cardiovasc Surg 3:199-205, 1995**
**Passman MA, PVS-V, 2005**

## Ambulation/Stockings

**Rate and Severity of Postthrombotic Syndrome after Proximal DVT can be decreased by 50% by the use of Compression Stockings**
**Brandjes DP et al, Lancet 349:759-762, 1997**
**Prandoni P et al, Pathophysiol Haemost Thromb 32:72, 2002**
**Walking with Good Compression does ****not**** Increase the Risk of PE, while significantly Decreasing the Incidence and Severity of the Postthrombotic Syndrome**
**Schellong SM et al, Thromb Haemost 82(Suppl 1):127-129, 1999**
**Aschwanden M et al, Thromb Haemost 85:42-46, 2001**
**Partsch H et al, Sem Vasc Surg 18:148-152, 2005**

**So, Once Patient Anticoagulated, Recommend Ambulation **
**with Support, either Stockings or Wrappings**

## Thank You

**Thank You**