DR. MAHMOUD RAZAVI

1. Advantages and Shortcomings ofAdvantages and Shortcomings of
Current Mechanical ThrombectomyCurrent Mechanical Thrombectomy
Devices in DVTDevices in DVT
Mahmood K. Razavi, MDMahmood K. Razavi, MD
Director, Clinical Trials & ResearchDirector, Clinical Trials & Research
Vascular & Interventional SpecialistsVascular & Interventional Specialists
of Orange Countyof Orange County

2. DisclosuresDisclosures
Scientific Advisory Board
– 480 Biomedical, Abbott Vascular, Bard, Boston
Scientific, Covidien, EmboMedix, Javlin, Mercator,
Neuravi, Reflow Medical, Trivascular, Veneti, Walk
Vascular
Consultant
– Cordis
Grants
– NIH, WL Gore

3. Mechanical Thrombectomy DevicesMechanical Thrombectomy Devices
29 different devices have been used (& growing)
Eleven are FDA cleared for use in the U.S.
(general thrombectomy indication)
Only few actively marketed

4. Mechanisms of ActionMechanisms of Action
Pure mechanical mechanism
– Aspiration
– Disruption/maceration
– Re-circulation
– Energy assisted (RF, laser, US)
Lytic assisted
– Pharmaco-mechanical

5. Partial List of PMT DevicesPartial List of PMT Devices
Angiojet DVX/ AVX
Xpeedior
Hydrolyzer
Helix/X-Sizer/Brush
Oasis
Trerotola Device
Resolution 360 wire
Akonya Eliminator
Aspirex/Rotarex
Thrombex PMT
ProLumen
Rinspirator
Cleaner

6. Lytic Assisted DevicesLytic Assisted Devices
Trellis-8 and Trellis-6
– Pharmacomechanical lysis
Ekos Lysus system
– Ultrasound accelerated lysis
Angiojet + lytics
– Power pulse

7. AdvantagesAdvantages
Speed up lysis
Potential for single session treatment
Reduced dose of lytics
May be used in pts with contraindication to
thrombolytic drugs

8. 67 yo F with 5 day hx of LLE edema and pain who is 7
days s/p spinal fusion.
US revealed extensive ilio-femoral DVT. IVC filter was
requested.
Retrievable IVC filter placed
Symptoms worsened over the next 2 days

12. 3 months later pt returned3 months later pt returned
for IVC filter removal.for IVC filter removal.
Sx had improved substantiallySx had improved substantially
but some residual ankle edemabut some residual ankle edema
persistedpersisted..

13. LimitationsLimitations
Paucity of data
– Prove efficacy
– Comparative analysis
– Long term safety
Largely ineffective as stand alone techniques
– Best results when used in combination with
lytics
Device-dependent increased risk of PE

14. Courtesy:Nick Yee MDCourtesy:Nick Yee MD

15. Efficacy of CDT in Acute DVTEfficacy of CDT in Acute DVT
8%
42%
50%
8%
37%
55%
13%
53%
34%
0
10
20
30
40
50
60
tPA TNK UK
Failed
partial lysis
Complete lysis
80% of clot removed in 80% of patients

16. Stand Alone PMT in DVTStand Alone PMT in DVT
Results of stand alone therapy in proximal DVT
disappointing
– 4/17 pts had >90% & 6/17 had 50%-90% clot
removal (10/17 >50% clot clearance)*
– 9 pt received additional CDT
Most studies report results of combination tx
– Drug during PMT
– Debulk prior to CDT or clean up after
* Kasirajan K. et al. JVIR 2001;12

17. 54 yo female with breast cancer and swollen Rt. arm54 yo female with breast cancer and swollen Rt. arm

18. Complete occlusion of rightComplete occlusion of right
axillary and subclavian veinaxillary and subclavian vein

19. Following 24 hours Urokinase treatmentFollowing 24 hours Urokinase treatment

20. 15 minutes angiojet thrombolysis15 minutes angiojet thrombolysis

21. PMT in DVTPMT in DVT
Aspiration thrombectomy in acute IF DVT
N= 27
Success= restoration of flow without residual
obstruction
Aspiration only 24
– UK infusion 3
Successful recanalization 24/27
– Adjunctive stents 22
Kwon SH, et al Clin Radiol 2009Kwon SH, et al Clin Radiol 2009

22. 40 year old male, 10 days post heart-lung transplant40 year old male, 10 days post heart-lung transplant
SwollenSwollen
face,face,
distendeddistended
neckneck
veinsveins

23. Complete occlusion of Superior Vena CavaComplete occlusion of Superior Vena Cava

24. 800 cc angiojet exchange and Palmaz 308 stent800 cc angiojet exchange and Palmaz 308 stent

25. Relief of venous distensionRelief of venous distension

26. PMT + CDT versus CDTPMT + CDT versus CDT
Retrospective analysis of 40 consecutive limbs (36
pts) with UE or LE DVT
CDT+ rheolytic PMT CDT alone P-value
Limbs (patients) 27 (21) 40 (36)
Tx duration (hrs) 26.3 ± 16.6 48 ± 27 0.0004
Mean UK dose (U) 2.7 ± 1.8 M 5.6 ± 5.3 M 0.008
Complete lysis 73% 82%
Kim HS et al Cardiovasc Interv Radiol 2006;29:1003-7Kim HS et al Cardiovasc Interv Radiol 2006;29:1003-7

27. Pharmacomechanical vs. CDTPharmacomechanical vs. CDT
Retrospective review of pts with LE DVT over 8
yrs
Lin PH et al Am J Surg 2006;192:782-788Lin PH et al Am J Surg 2006;192:782-788
Rheolytic + lytics CDT P-value
Limbs (patients) 52 (49) 46 (44)
Complete success 75% 70% ns
Sx improved 24 hr 81% 72% ns
Adjuvant stents 82% 78% ns
Mean ICU stay 0.6 ± 0.3 d 2.4 ± 1.2 d < 0.04
Bleed 4% 6% ns
Transfusion 0.2 ± 0.3 1.2 ± 0.7 < 0.05
Total costs $47,742 ± $19,247 $85,301 ± 24,832 < 0.01

28. D V T R e s u lt s a t F in a l A n g io g r a m
7 0 %
3 1 %
2 1 %
5 2 %
9 %
1 7 %
0 %
1 0 %
2 0 %
3 0 %
4 0 %
5 0 %
6 0 %
7 0 %
8 0 %
E K O S ( n = 5 3 )
M e a n F in a l A n g io
2 4 . 9 h o u r s
N V R ( n = 2 8 7 )
M e a n F in a l A n g io
5 3 . 4 h o u r s
C o m p le t e L y s is
P a r t ia l L y s is
N o L y s is
EKOS Study Results: EfficacyEKOS Study Results: Efficacy
Parikh S. et al JVIR 2008; 19

29. Registry DemographicsRegistry Demographics
Number of Patients 147
Age 51 ± 18 years
Gender
– Men 68 (46%)
– Women 70 (48%)
– Not Reported 9 (6%)
Clinical Presentation Average Days
Onset of DVT
– Acute (<14 days) 33 (22%) 8
– Acute on Chronic (<14 days; prior Hx DVT) 63 (43%) 19*
– SubAcute (14 to 28 days) 19 (13%) 21
– SubAcute on Chronic (14 – 28 days; prior Hx DVT) 14 (10%) 19
– Chronic (> 28 days) 18 (12%) 67
* Average > 14 days due to occasional reporting of days since onset of original DVT
episode that resulted in chronic part of acute-on-chronic

30. Reported Degree of Clot Clearance with Trellis
Hilleman DE JVIR 2008; 19

31. ConclusionConclusion
Role of mechanical thrombectomy devices as the
“stand alone” mode of therapy in treatment of DVT
is limited at this time
Combination of thrombolysis and mechanical
thrombectomy can reduce the treatment time &
possibly the bleeding complications of thrombolysis