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Isolated Thrombolysis for DVT. DVT Treatment with the Trellis ® Peripheral Infusion System Manufacturer’s Registry Report Gerard J. O’Sullivan MD Mahmood Razavi MD. Deep Vein Thrombosis. 900,000 patients diagnosed annually USA Probably the same number again undiagnosed

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isolated thrombolysis for dvt

Isolated Thrombolysis for DVT

DVT Treatment with the Trellis® Peripheral Infusion System

Manufacturer’s Registry Report

Gerard J. O’Sullivan MD

Mahmood Razavi MD

deep vein thrombosis
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)
catheter directed thrombolysis
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
pharmaco mechanical thrombectomy pmt
Pharmaco-mechanical thrombectomy (PMT)
  • A combination of
    • Physical maceration of the clot
    • Drug dispersal through clot
    • Aspiration of that clot out of the body
trellis peripheral infusion system
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

data set
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

thrombolytic therapy for dvt patient benefits
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

clinical presentation venous only
Clinical Presentation – Venous Only

However,44% of cases demonstrated venographic evidence of a previous DVT

74% of cases presented acutely based on patient symptoms

final patency by age of clot
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.

adjunctive therapies all clots n 771
Adjunctive Therapies – All ClotsN=771

77% occurred during primary

procedure

  • Note: More than one adjunctive maneuver may have been performed during the procedure
reason for adjunctive maneuvers
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

single vs non single setting
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
summary of lytic doses
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

case 1
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
slide17

LEFT RIGHT

case 2
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
slide21

24 hours later………

Back to work in one week

summary
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

take home points
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!!