Transcript Slide - Society Of Interventional Radiology

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
• 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
• 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)
• A combination of
– Physical maceration of the clot
– Drug dispersal through clot
– Aspiration of that clot out of the body
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
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
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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 - 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 – Venous Only
Number of Patients
771
Number of Limbs
827
Age
Gender
Female
Male
Not Reported
54 +/-30
391 (51%)
351 (45%)
29 ( 4%)
Clinical Presentation of Clot
Acute
248 (30%)
360 (44%)
74% of cases Acute on Chronic
SubAcute
87 (10%)
presented
SubAcute on Chronic
89 (11%)
acutely based
on patient
symptoms
Chronic
43 ( 5%)
However,
44% of cases
demonstrated
venographic
evidence of a
previous DVT
Clinical Presentation (continued)
Thrombus Location
N=827 limbs
Lower Extremity
703 (85.0%)
IVC Only
Iliac Involvement
554 (78.8%)
Femoro-Popliteal
145 (20.6%)
4 ( 0.5%)
Upper Extremity
111(13.4%)
Subclavian Only
100 (90.1%)
Subclavian Involvement
11( 9.9%)
Other (azygous, portal)
13 (1.6%)
Final Patency by Age of Clot
Acute
Acute on
Chronic
Grade I
8 (3.2%)
Grade II
Grade III
Comb II/III
SubAcute
SubAcute on
Chronic
Chronic
23 (6.4%)
4 (4.6%)
10 (11.2%)
4 (9.3%)
107 (43.1%)
218 (60.6%)
59 (67.8%)
48 (53.9%)
29 (67.4%)
133 (53.6%)
119 (33.1%)
24 (27.6%)
31 (34.8%)
10 (23.3%)
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 = >95% thrombus removal
Grade II = > 50% - 94% thrombus removal
Grade I = < 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.
Adjunctive Therapies – All Clots
N=771
Adjunctive Measure*
None
PTA Alone
Stent Alone
PTA and Stent
CDT
PMT
Other (Embolectomy)
91 (12%)
351 (46%)
33 ( 4%)
211 (27%)
104 (13%)
40 (5%)
80 (10%)
77% occurred
during primary
procedure
•Note: More than one adjunctive maneuver may have been performed during the procedure
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
Single vs. Non-single Setting
Single
Setting
Non-single
Setting
Acute
201 (83.8%)
Acute on Chronic
260 (77.2%)
SubAcute
64 (77.1%)
SubAcute on
Chronic
65 (82.3%)
39 (16.3%)
77 (22.8%)
19 (22.9%)
14 (17.7%)
Chronic
37 (94.9%)
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 Doses
t-PA
714
Retavase
21
UK
12
TNK
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
Number of Patients*
* 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
• 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 2
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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
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
• 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!!