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Contemporary management of iliofemoral venous thrombosis
1. Contemporary Management ofContemporary Management of
Iliofemoral Venous ThrombosisIliofemoral Venous Thrombosis
Anthony J. Comerota, MD, FACS, FACC
Director,
Jobst Vascular Institute
Adjunct Professor of Surgery,
University of Michigan
2. • 22yo. woman, referred from outside hospital
• 3X Ohio State Champion
400 meter dash
800 meter run
• Track scholarship to the Ohio State University
• Iliofemoral DVT after BCP in 2007
• Treated with anticoagulation
• Venous claudication/painful left leg
…lost scholarship
…no longer in college
Iliofemoral DVT
Case from TuesdayCase from Tuesday
3. Mainstream Rx
Clot removal was
not a part of
recommendation
for care
2004
Acute Venous Thromboembolism
These guidelines were
in place until July, 2008
4. Which acute DVT patients benefit from a
strategy of thrombus removal?
Initial Question…
ANSWER: Probably all, but iliofemoral DVT
for sure!
Why iliofemoral DVT patients?
5. • Single venous outflow channel occluded
• Most severe postthrombotic morbidity
when treated with anticoagulation alone
• Significant increased risk of recurrence
Why Iliofemoral DVT Patients?
7. Venous Thrombectomy
Iliofemoral DVT
If this is not removed…If this is not removed…
and permitted to organize…and permitted to organize…
It will result in…It will result in…
11. Clinical OutcomeClinical Outcome
C-6C-6
• UlcerationUlceration
• On DisabilityOn Disability
• Poor QOLPoor QOL
……or…or…
- Actual Photo -- Actual Photo -
Iliofemoral DVT
Anticoagulation AloneAnticoagulation Alone
12. 3 Years Post Thrombus Removal
• Hairdresser
• No edema
• Asymptomatic Normal
valve function
Actual outcomeActual outcome
Post-ThrombectomyPost-Thrombectomy
- Actual Photo -- Actual Photo -
Iliofemoral DVT
13. Intramuscular Pressures (mmHg)
Iliofemoral DVT
Days
Intramuscular
Pressure
(mmHg)
Anterior & Deep Posterior Compartments (Mean)
Qvarfordt P et al
Ann Surg 1983;197:450
• 12 Patients with iliofemoral DVT
• Venous thrombectomy
• Intramuscular pressures (wick)
(Surrogate for venous pressure)
Pre-Op
(Mean)
Post-Op
(Mean)
Reduction of pressure to normalReduction of pressure to normal
after thrombus removalafter thrombus removal
14. PathophysiologyPathophysiology
Strategy of Thrombus Removal
Ambulatory venous hypertension is
THE underlying pathophysiology of
chronic venous disease/PTS
How can we expect post-thrombotic
venous pressures to be normal if
obstructing thrombus is not removed?
15. 0
20
40
60
80
100
120
20 40 60
LegworkLegwork
16˚ steps per minute
Seconds
mmHg
Severe
Postphlebitic Syndrome
Mild to Moderate
Normal Controls
Ambulatory Venous HypertensionAmbulatory Venous Hypertension
Components:
Valvular Incompetence
Obstruction
Pathophysiology
Chronic Venous Insufficiency
IncompetenceIncompetence
Plus ObstructionPlus Obstruction
16. FindingsFindings
• 1 month observation was best predictor of1 month observation was best predictor of
long-term outcome (p<0.001)long-term outcome (p<0.001)
• IFDVT patients had the most severeIFDVT patients had the most severe
post-thrombotic morbidity (OR 2.23; p<0.001)post-thrombotic morbidity (OR 2.23; p<0.001)
Acute DVT
Outcomes After Anticoagulation AloneOutcomes After Anticoagulation Alone
Ann Int Med 2008; 149:698Ann Int Med 2008; 149:698
26. Acute DVT
What’s New in Venous Disease?
RecommendationsRecommendations
“In […patients] with extensive
DVT…operative venous
thrombectomy may be used to
reduce acute symptoms and post-
thrombotic morbidity…”
…GRADE 2B…
2008
28. Baekgaard N et al
Eur J Vas Endovas Surg 2009
Long-Term Follow-Up (N=103)
Catheter-Directed Thrombolysis for IFDVT
ResultsResults
–– Patency Without Reflux –Patency Without Reflux –
82% at 6 years
Following successful lysisFollowing successful lysis
recurrent DVT in 6% at 6 yearsrecurrent DVT in 6% at 6 years
Following successful lysisFollowing successful lysis
recurrent DVT in 6% at 6 yearsrecurrent DVT in 6% at 6 years
29. Strategy of Thrombus Removal: QOL
QOL Measure CDT No CDT p-value
Health Util Index .83 .74 0.032
Role Physical 75.6 56.5 0.013
Health Distress 82.4 64.1 0.007
Stigma 85.9 71.3 0.033
Overall Symptom 78.5 55.5 <0.001
CDT vs AnticoagulationCDT vs Anticoagulation
Comerota AJ et al
JVS 2000;32:130-7.
–– Cohort Controlled Study –Cohort Controlled Study –
• Significantly better QOL with
CDT plus anticoagulation
• Lytic failures had same QOL
as anticoagulation alone
• Significantly better QOL with
CDT plus anticoagulation
• Lytic failures had same QOL
as anticoagulation alone
30. Catheter-Directed Thrombolysis for IFDVT
Randomized TrialsRandomized Trials
–– Patency –Patency –
(6 Months)(6 Months)
Lysis Anticoag p-value
Elsharawy et al
Eur J Vasc Endovasc Surg 2002; 24:209
(N=35)
72% 12% <0.001
Enden et al
J Thromb Haemost 2009; 7:1268
(N=103)
64% 36% 0.004
31. Catheter-Directed Thrombolysis for IFDVT
Randomized TrialsRandomized Trials
–– Normal Valve Function –Normal Valve Function –
(6 Months)(6 Months)
Lysis Anticoag p-value
Elsharawy et al
Eur J Vasc Endovasc Surg 2002; 24:209
(N=35)
89% 59%* 0.041
Enden et al
J Thromb Haemost 2009; 7:1268
(N=103)
40% 34%* 0.53
*Reflux cannot occur in occluded veins*Reflux cannot occur in occluded veins
32. •65 yo Caucasian male
•Chronic low back pain
…worse x one month
•Phlegmasia cerulea dolens
•Venous duplex:
Clot post tib → Ext. iliac
vein
Phlegmasia Cerulea Dolens
44. S/P Pharmacomechanical Thrombolysis
Phlegmasia Cerulea Dolens: Severe
–– 12 Month Follow-Up –12 Month Follow-Up –
• Patent veins
• Normal valve function
• No edema
• Full activity
• Asymptomatic
45. Strategy of Thrombus Removal: QOL
QOL Measure CDT No CDT p-value
Health Util Index .83 .74 0.032
Role Physical 75.6 56.5 0.013
Health Distress 82.4 64.1 0.007
Stigma 85.9 71.3 0.033
Overall Symptom 78.5 55.5 <0.001
CDT vs AnticoagulationCDT vs Anticoagulation
Comerota AJ et al
JVS 2000;32:130-7.
–– Cohort Controlled Study –Cohort Controlled Study –
• Significantly better QOL with
CDT plus anticoagulation
• Lytic failures had same QOL
as anticoagulation alone
• Significantly better QOL with
CDT plus anticoagulation
• Lytic failures had same QOL
as anticoagulation alone
46. Strategy of Thrombus Removal: QOL
SF-36 Measure
Group I
(>50%)
Group II
(<50%) p-value
Physical Fct 48.1 37.3 0.035
Role Physical 48.5 35.8 0.013
General Health 49.0 39.0 0.014
Vitality 51.7 36.2 <0.001
Social Fct 49.0 38.4 0.038
Percent Lysis vs QOLPercent Lysis vs QOL
Grewal P et al
J Vasc Surg 2010 (in press)
47. Results: Villalta Score vs Percent Lysis
Outcome Measures after IFDVT Lysis
1.00.90.80.70.60.50.40.30.2
14
12
10
8
6
4
2
0
Percent Lysis
VillalteScore
0.5
<=50%
> 50%
Group
Villalta Score Distribution
Mean Villalta score difference (7.13 versus 2.21) with p-value 0.025
p=0.025 Group
≤50%
>50%
VillaltaScore
Percent Lysis
Grewal P et al
Am Ven Forum 2010
Essentially NO PTS withEssentially NO PTS with
≥90% clot lysis!≥90% clot lysis!
Essentially NO PTS withEssentially NO PTS with
≥90% clot lysis!≥90% clot lysis!
48. Acute DVT
What’s New in Venous Disease?
RecommendationsRecommendations
“In […patients] with extensive
proximal DVT…and low risk for
bleeding…we suggest that CDT
may be used to reduce acute
symptoms and post-thrombotic
morbidity…”
…GRADE 2B…
2008
49. Acute DVT
What’s New in Venous Disease?
RecommendationsRecommendations
“We suggest
pharmacomechanical
thrombolysis, in preference to
CDT alone, to shorten treatment
time…”
…GRADE 2C…
2008
50. Can success be improved withCan success be improved with
pharmacomechanical techniques?pharmacomechanical techniques?
Catheter-Directed Thrombolysis for IFDVT
56. Can success be improved withCan success be improved with
pharmacomechanical techniques?pharmacomechanical techniques?
Catheter-Directed Thrombolysis for IFDVT
YES!YES!
- Shorter treatment times- Shorter treatment times
- Lower dose of plasminogen activator- Lower dose of plasminogen activator
- More effective thrombus removal- More effective thrombus removal
57. Does PharmacomechanicalDoes Pharmacomechanical
thrombolysis adversely affectthrombolysis adversely affect
venous valve function vs. CDTvenous valve function vs. CDT
drip technique alone?drip technique alone?
Question?Question?
CDT Vs. PMT
–– Valve Function –Valve Function –
62. ConclusionsConclusions
1. No adverse effect of PMT on venous
valve function
2. Unexpectedly high frequency of venous
reflux following successful lysis
3. Unexpectedly high rates of reflux in
contralateral (uninvolved) limbs
CDT Vs. PMT
Vogel D et al
Am Venous Forum 2011
63. ObservationObservation
Few patients develop recurrent DVT…
…many fewer than reported in the literature
Catheter based Strategy of Thrombus Removal
Question?Question?
Does successful CDT/PMT
reduce recurrent DVT?
64. 75 Patients
35 month follow-up
(Range 1 – 144 Months)
Recurrence = 7 (9%)
Outcome Measures after IFDVT Lysis
Initial Lysis
(1-100)
Clinical Class
of CEAP
(0-6)
Villalta Score
(0-33)
79%
(mean)
1.4
(mean)
3.81
(mean)
Overall ResultsOverall ResultsOverall ResultsOverall Results
Aziz F et al
Am Venous Forum 2011
65. > 50% Residual
Thrombus
≤ 50% Residual
Thrombus
75 Patients
(Follow-up 35 months – mean)
Results by GroupResults by GroupResults by GroupResults by Group
RecurrenceRecurrence
5% (3/67)5% (3/67)
RecurrenceRecurrence
5% (3/67)5% (3/67)
RecurrenceRecurrence
38% (3/8)38% (3/8)
RecurrenceRecurrence
38% (3/8)38% (3/8)
Results
p=0.0014
Aziz F et al
Am Venous Forum 2011
66. ConclusionsConclusions
Catheter based Strategy of Thrombus Removal
• Effective (preferred) for IFDVT
• Reduces PTS
• Improves QOL
• PMT more rapid/efficient
• PMT does not affect valve function
• Successful lysis reduces recurrence
Editor's Notes
First Slide after Title Slide only (or first slide with title)! Use only once.
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First Slide after Title Slide only (or first slide with title)! Use only once.
In group 1 which had a mean lysis of 42% the mean clinical classification score of CEAP was 3.38 compared to group 2 which had a mean lysis of 85% and a mean score of 0.89 with a p-value of 0.011. That’s a difference between having lower extremity edema versus merely telangiectasias. Similarly in group 1 the mean Villalta score is 7.13 compared to 2.21 in group 2 with a p-value of 0.025. That’s is the difference between having post-thrombotic syndrome as is defined by a Villalta score of &gt;5 and NOT having PTS!
In group 1 which had a mean lysis of 42% the mean clinical classification score of CEAP was 3.38 compared to group 2 which had a mean lysis of 85% and a mean score of 0.89 with a p-value of 0.011. That’s a difference between having lower extremity edema versus merely telangiectasias. Similarly in group 1 the mean Villalta score is 7.13 compared to 2.21 in group 2 with a p-value of 0.025. That’s is the difference between having post-thrombotic syndrome as is defined by a Villalta score of &gt;5 and NOT having PTS!
In group 1 which had a mean lysis of 42% the mean clinical classification score of CEAP was 3.38 compared to group 2 which had a mean lysis of 85% and a mean score of 0.89 with a p-value of 0.011. That’s a difference between having lower extremity edema versus merely telangiectasias. Similarly in group 1 the mean Villalta score is 7.13 compared to 2.21 in group 2 with a p-value of 0.025. That’s is the difference between having post-thrombotic syndrome as is defined by a Villalta score of &gt;5 and NOT having PTS!
We then plotted each patient in our study with their percent lysis and villalta score. You can appreciate the direct linear correlation between the percentage lysis and the Villalta score. The as the degree of lysis increases the villalta score decreases. And this is with statistical significance.
First Slide after Title Slide only (or first slide with title)! Use only once.
First Slide after Title Slide only (or first slide with title)! Use only once.
Thus we asked the question Does PMT adversely affect venous valve function v CDT alone
We found that 68% of all of our patients had reflux which is higher than other reports stating a good as 11% reflux rates at 6 months and 33% reflux rates at 2 years.
In fact there was no difference between reflux in the treated limb vs the contralateral limb.
Patients with bilateral DVT had a higher incidence of reflux at 73%
There was also no significant difference between CDT and PMT on the effect of valve function in our patient population
In conclusion, in patients undergoing catheter based thrombolysis the mode of lysis employed does not adversely affect valve function nor does the amount of residual obstruction in the iliofemoral segment. A larger than expected number of patients had bilateral venous reflux. In fact valve function actually best correlated with the valve function in the unaffected limb in patients with unilateral acute DVT.
Thus it begs the question does venous reflux really play a major role in PTS or is the primary offender luminal obstruction?
In conclusion, in patients undergoing catheter based thrombolysis the mode of lysis employed does not adversely affect valve function nor does the amount of residual obstruction in the iliofemoral segment. A larger than expected number of patients had bilateral venous reflux. In fact valve function actually best correlated with the valve function in the unaffected limb in patients with unilateral acute DVT.
Thus it begs the question does venous reflux really play a major role in PTS or is the primary offender luminal obstruction?
We were pleased to find that we achieved an average 79% clot remova initallyl and that average clinical class of CEAp was 1.4, and average vilalta score was 3.81, which is well below the threshold for definition of PTS. (5-8 is minor)
- In general, this represents a favorable long-term outcome
In conclusion, in patients undergoing catheter based thrombolysis the mode of lysis employed does not adversely affect valve function nor does the amount of residual obstruction in the iliofemoral segment. A larger than expected number of patients had bilateral venous reflux. In fact valve function actually best correlated with the valve function in the unaffected limb in patients with unilateral acute DVT.
Thus it begs the question does venous reflux really play a major role in PTS or is the primary offender luminal obstruction?
