Isolated Thrombolysis for DVT

1. Isolated Thrombolysis for DVT DVT Treatment with the Trellis® Peripheral Infusion System Manufacturer’s Registry Report Gerard J. O’Sullivan MD Mahmood Razavi MD

2. 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)

3. 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

4. Pharmaco-mechanical thrombectomy (PMT) • A combination of • Physical maceration of the clot • Drug dispersal through clot • Aspiration of that clot out of the body

5. 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

6. 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

7. Thrombolytic Therapy for DVTPatient 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

8. Vessel Types Treated - Overview

9. Clinical Presentation – Venous Only However,44% of cases demonstrated venographic evidence of a previous DVT 74% of cases presented acutely based on patient symptoms

10. Clinical Presentation (continued)

11. Final Patency by Age of Clot 97% Grade II and III lysis with restoration of patency in patients with acute clot Lysis Grading Scale1 Grade III = >95% thrombus removal Grade II = > 50% - 94% thrombus removal Grade I = < 50% thrombus removal 1Vedantham S et al. “Reporting Standards for Endovascular Treatment of Lower Extremity Deep Vein Thrombosis.” J Vasc. Interv Radiol 2006 17; 417-434.

12. Adjunctive Therapies – All ClotsN=771 77% occurred during primary procedure • Note: More than one adjunctive maneuver may have been performed during the procedure

13. Reason for Adjunctive Maneuvers 76% of maneuvers were due to underlying chronic obstruction or culprit lesion- if this lesion was not treated, high likelihood of recurrence of DVT

14. Single vs. Non-single Setting • Vast majority of cases (> 80%) completed in single setting in less than 2 hours and achieved Grade II or III lysis • Average Trellis-use time was 22 minutes

15. Summary of Lytic Doses * N=771, 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

16. 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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19. 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

20. One of the worst cases of DVT I have seen- straight to IR lab

21. 24 hours later……… Back to work in one week

22. 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

23. 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!!