Isolated Thrombolysis for DVT

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Isolated Thrombolysis for DVT

• DVT Treatment with the Trellis Peripheral
  Infusion System
• Manufacturers Registry Report
• Gerard J. OSullivan MD
• Mahmood Razavi MD

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Deep Vein Thrombosis

• 900,000 patients diagnosed annually USA
• Probably the same number again undiagnosed
• Treatment has barely altered in 40 years
• Bed Rest
• Anticoagulation
• Anticoagulation does NOT attack the clot, it
  merely decreases the risk of spread of that clot
• Interventional Radiology has been at the
  forefront of more aggressive therapies
• Catheter Directed Thrombolysis- CDT- (1994)

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Catheter Directed Thrombolysis

• Basically anti clot drugs dripped in through a
  small garden hose type system over an average of
  2-3 days
• Needs ICU bed/ frequent lab checks/ trips to IR
• Small risk of bleeding
• Good results

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Pharmaco-mechanical thrombectomy (PMT)

• A combination of
• Physical maceration of the clot
• Drug dispersal through clot
• Aspiration of that clot out of the body

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Trellis Peripheral Infusion System

• Designed for single-setting DVT thrombolysis
• Treatment area isolated within occluding balloons
• Targeted delivery of thrombolytic agents
• Mechanical dispersion of infused thrombolytic
  agents
• Aspiration following treatment

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Data Set

• 827 venous limbs in 771 patients
• Cases performed between February 2005 and
  February 2008
• 362 US and OUS sites
• All used Trellis Peripheral Infusion System
• - 8 Fr OD, .035 guidewire - 15 30 cm
  treatment lengths - 80 120 cm catheter lengths

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Thrombolytic Therapy for DVT Patient Benefits

• Immediate restoration of vein patency
• Immediate resolution of patient symptoms
• Preservation of valve function
• Valves prevent blood from falling back downwards
  in the leg when the patient is in the erect
  position
• Lower risk of Venous Hypertension
• Reduction in recurrent DVT
• Lower likelihood of Post Thrombotic Syndrome

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Vessel Types Treated - Overview
Venous 771 (94.7)
Arterial 27 ( 3.3)
Bypass Graft 4 ( 0.5)
Dialysis Access 11 ( 1.4)
Not Reported 1 ( 0.1)
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Clinical Presentation Venous Only
Number of Patients 771
Number of Limbs 827

Age 54 /-30
Gender
Female 391 (51)
Male 351 (45)
Not Reported 29 ( 4)

Clinical Presentation of Clot
Acute 248 (30)
Acute on Chronic 360 (44)
SubAcute 87 (10)
SubAcute on Chronic Chronic 89 (11) 43 ( 5)
However,44 of cases demonstrated venographic
evidence of a previous DVT
74 of cases presented acutely based on patient
symptoms
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Clinical Presentation (continued)
Thrombus Location Lower Extremity N827 limbs 703 (85.0)
IVC Only Iliac Involvement 4 ( 0.5) 554 (78.8)
Femoro-Popliteal 145 (20.6)

Upper Extremity 111(13.4)
Subclavian Only Subclavian Involvement 100 (90.1) 11( 9.9)

Other (azygous, portal) 13 (1.6)
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Final Patency by Age of Clot
Acute Acute on Chronic SubAcute SubAcute on Chronic Chronic
Grade I 8 (3.2) 23 (6.4) 4 (4.6) 10 (11.2) 4 (9.3)
Grade II 107 (43.1) 218 (60.6) 59 (67.8) 48 (53.9) 29 (67.4)
Grade III 133 (53.6) 119 (33.1) 24 (27.6) 31 (34.8) 10 (23.3)
Comb II/III 183 (96.7) 252 (93.7) 72 (95.4) 60 (88.7) 32 (90.7)
97 Grade II and III lysis with restoration of
patency in patients with acute clot
Lysis Grading Scale1 Grade III gt95 thrombus
removal Grade II gt 50 - 94 thrombus
removal Grade I lt 50 thrombus removal
1 Vedantham S et al. Reporting Standards for
Endovascular Treatment of Lower Extremity Deep
Vein Thrombosis. J Vasc. Interv Radiol 2006 17
417-434.
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Adjunctive Therapies All ClotsN771
Adjunctive Measure
None 91 (12)
PTA Alone 351 (46)
Stent Alone 33 ( 4)
PTA and Stent 211 (27)
CDT 104 (13)
PMT 40 (5)
Other (Embolectomy) 80 (10)
77 occurred during primary procedure

• Note More than one adjunctive maneuver may have
  been performed during the procedure

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Reason for Adjunctive Maneuvers
Reason
Additional vessel treated 39 ( 5.9)
Chronic substrate 226 (34.1)
Obstruction/lesion 279 (42.1)
Partial Clot Removal 118 (17.8)
76 of maneuvers were due to underlying chronic
obstruction or culprit lesion- if this lesion
was not treated, high likelihood of recurrence
of DVT
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Single vs. Non-single Setting
Acute Acute on Chronic SubAcute SubAcute on Chronic Chronic
Single Setting 201 (83.8) 260 (77.2) 64 (77.1) 65 (82.3) 37 (94.9)
Non-single Setting 39 (16.3) 77 (22.8) 19 (22.9) 14 (17.7) 2 (5.1)

• Vast majority of cases (gt 80) completed in
  single setting in less than 2 hours and achieved
  Grade II or III lysis
• Average Trellis-use time was 22 minutes

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Summary of Lytic Doses
t-PA Retavase UK TNK
Number of Patients 714 21 12 23
Average Lytic Dose Per Run 6.0 /-2.2 mg 5.2 /-2.7 U 307k /-87 U 4.8 /-2.2 mg
Total Lytic Dose Per Patient 13.4 /-6.7 mg 12.1 /-7.4 U 690k /-327 U 11.2 /-7.3 mg
N771, 1 case used heparinized saline as the
infusate

• 93 of cases used t-PA
• Compared to CDT, doses are appreciably reduced
  delivered in a single setting
• No reported bleeding complications in acute
  follow up

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Case 1

• 60 year old lady
• Failed traditional therapy for DVT
• Left leg massively swollen after 6 weeks of this
  treatment
• Referred to Interventional Radiology for Trellis
  treatment

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LEFT
RIGHT
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LEFT
RIGHT
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Case 2

• 57 year old construction worker
• Never sick in his life
• Right leg felt heavy
• Went to doctor, sent for Ultrasound scan
• Negative for DVT
• 2 days later right leg felt worse
• Came to ER
• Referred directly to Interventional Radiology

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One of the worst cases of DVT I have seen-
straight to IR lab
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24 hours later Back to work in one week
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Summary

• Largest prospective database of DVT intervention
• Isolated pharmaco-mechanical thrombolysis removes
  thrombus to restore vessel patency
• 97 Grade II III Lysis achieved
• Clot removal tallies with clinical improvement
• Isolated pharmaco-mechanical thrombolysis
  substantially reduces lytic dose and time to
  restore venous patency compared to CDT
• Completed in a single setting in the majority of
  cases in less than 2 hours
• No reported bleeding complications in acute
  follow up

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Take home points

• Interventional Radiologists are experts in
  management of Deep Vein Thrombosis
• IR doctors can help primary physicians determine
  the best course of action for particular
  patients
• If leg is tense or blue IMMEDIATE referral is
  mandatory
• Treatment using the Trellis isolated thrombolysis
  catheter is QUICK, SAFE and EFFECTIVE
• DVT patients across America deserve better!!