Isolated Thrombolysis for DVTIsolated Thrombolysis for DVT

DVT Treatment with the Trellis® Peripheral Infusion System

Manufacturer’s Registry Report

Gerard J. O’Sullivan MDMahmood Razavi MD

Deep Vein ThrombosisDeep 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 ThrombolysisCatheter 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 SystemTrellis 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 SetData 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 DVTThrombolytic Therapy for DVT Patient BenefitsPatient 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

Vessel Types Treated - OverviewVessel 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%)

Clinical Presentation Clinical Presentation – Venous Only– 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%)

74% of cases presented acutely based on patient symptoms

However,

44% of cases demonstrated venographic evidence of a previous DVT

Clinical Presentation Clinical Presentation (continued)(continued)

Thrombus Location

Lower Extremity

N=827 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%)

Final Patency by Age of ClotFinal Patency by Age of Clot

AcuteAcute 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%)

Lysis Grading Scale1

Grade III = >95% thrombus removalGrade II = > 50% - 94% thrombus removalGrade I = < 50% thrombus removal

97% Grade II and III lysis with restoration of patencyin patients with acute clot

1 Vedantham S et al. “Reporting Standards for Endovascular Treatment of Lower Extremity Deep Vein Thrombosis.” J Vasc. Interv Radiol 2006 17; 417-434.

Adjunctive Therapies Adjunctive Therapies – All Clots– All ClotsN=771N=771

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

77% occurred during primaryprocedure

Reason for Adjunctive ManeuversReason 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

Single vs. Non-single SettingSingle vs. Non-single Setting

Acute Acute on Chronic SubAcuteSubAcute 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 (> 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 DosesSummary of Lytic Doses

t-PA Retavase UK TNKNumber 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

• 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

* N=771, 1 case used heparinized saline as the infusate

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

LEFT RIGHT

LEFT RIGHT

Case 2Case 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

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

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

SummarySummary

• 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 pointsTake 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!!