Chronic Ilio-caval Obstruction – Stenting the Venous Outflow Peter Neglén, MD, PhD Vascular Surgeon Cyprus
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Chronic Ilio-caval Obstruction –Stenting the Venous Outflow
Peter Neglén, MD, PhDVascular Surgeon
Cyprus
Stockholder of Veniti, Inc.
Member of SAB, AngioDynamics
Wallstents and nitenol stents are used “off-label,” e.g.,
the use for iliac venous stenting is not described on the
product’s label.
Faculty DisclosurePeter Neglén, M.D., Ph.D
Chronic venous disease - Obstruction or reflux?
CVI (C3-C6) – think obstruction
The femoro-ilio-caval vein is the final pathway for
the lower extremity venous outflow
• Venous outflow obstruction plays an important role in clinical expression of CVD, particularly pain.
• Ulcerated limbs have a high rate of obstruction (~40%).
• In limbs with obstruction, ulcers occur rarely with isolated obstruction (4%), more often in association with reflux (30%).
• Treatment results in impressive clinical relief of pain, swelling, VCSS, VDS and QoL, even when associated reflux is left untreated.
• Treatment results in healing of ulcers, despite untreated reflux, in 58-65% of the patients.
Why think ilio-femoral obstruction?
[Neglén et al, J Vasc Surg 2003;38:879-85]
[Hartung et al, J Vasc Surg 2005;42:1138-44]
[Neglén et al, J Vasc Surg 2007;46:979-90]
[Delis KT et al. Ann Surg 2007, 245:130-9]
[Marston et al, J Vasc Surg 2011; in press]
[Ascher et al, pers com, 2011]
Postthrombotic iliac veins
Non-thrombotic Iliac Vein Lesion (NIVL)
• May-Thurner or Cockett’s Syndrome –• Iliac vein compression
• Intraluminal lesions, e.g., webs, spurs, chords
• Non-thrombotic iliac vein lesions
• Left/right = 3/1
• Female/male = 4/1
• Median age 54 years (range: 18-90)
• Proximal and distal lesion
• Clinical impact without previous DVT.Raju & Neglén J Vasc Surg 2006;44:136-44
Non-thrombotic Iliac Vein Lesion
The impact of iliac vein compression on
acute DVT and postthrombotic obstruction
• Often underlying compression-type lesions found (left 84%, right 66%)
• Poor recanalization with external compression of the iliac vein (70-80% remains obstructed)
• Stenting of the stenosis after clot removal improves patency from 27-44% to 86-93%
Juhan CM et al. J Vasc Surg 1997;25:417-22.
Mickley V et al. J Vasc Surg 1998;28:492-7
Wohlgemuth WA et al. Cardiovasc Intervent Radiol 2000;23:9-16
Fraser et al. J Vasc Surg 2004;40:612-19
Chung JW et al. J Vasc Interv Radiol 2004;15:249-56
Deleterious effects by residual postthrombotic
ilio-femoral (IF) vein obstruction
• Recurrence rate of IF DVT x 2.4 higher than limited to FV
• 100% contralateral DVT with conservative tx of unilateral ilio-caval thrombus (if removed 7%)
• Proximal obstruction may lead to distal valve incompetence
• More severe symptoms than femoro-popliteal disease after conservative treatment, poor collateralization
– 90% venous hypertension, ulcer in 15% within 5 years, decreased quality of life
– Venous claudication in 15-44%, with IF stenting symptoms were eliminated
Akesson et al. Eur J Vasc Surg 1990, 4;43-8
Delis KT et al. Ann Surg 2004, 239:118-26
Delis KT et al. Ann Surg 2007, 245:130-9
Comerota AJ et al. J Vasc Surg 2000, 332:130-7
Neglén et al. Eur J Vasc Surg 1991, 6:78-82
Douketis JD et al.Am J Med 2001, 110:589-90
Caps et al. J Vasc Surg 1995, 22:524-31
• Ilio-femoral venous outflow obstruction plays an important role in clinical expression of CVD, particularly pain.
– Pain – complete relief 65% (improved 74%) @ 5 y
– Swelling – complete relief 32% (improved 62%) @ 5 y
– The impressive clinical relief of pain and swelling even when associated reflux is left untreated.
• Stent placement results in sustained healing of ulcers despite untreated reflux (~60% @ 5y)
The clinical response to stenting of the
IF obstruction
[Neglén, Thrasher, Raju, J Vasc Surg 2003;38:879-85]
[Neglén et al, J Vasc Surg 2007;46:979-90]
QoL-Scores(CIVIQ)
Total score (mean±SD)
Pre Post
Leg pain 3.5±1.1 2.6±1.2***
Work 3.5±1.1 2.7±1.3***
Sleep 3.2±1.3 2.5±1.3***
Social
activity25.1±8.4 21.4±9.0***
Morale 26.0±9.8 22.1±9.7***
VCSS 8.5 (range: 4-18)
2 (range: 2-3)
VDS 2 (range:0-9)
0 (range:0-2)
Hartung O, et al. J Vasc Surg 2005;42:1138-44
Neglén et al. J Vasc Surg 2007;46:979
The response to stenting of the IF
obstruction alone in combined
obstructive and reflux disease
Non-thrombotic iliac vein lesion (NIVL)
and primary reflux
Cumulative outcome at 2.5
years after stenting
NIVL with
reflux(n=151)
NIVL without
reflux(n=181)
No pain 82% 77%
No swelling 47% 53%
Ulcer healed 67% 76%
Good/excellent outcome 75% 79%
Raju & Neglén J Vasc Surg 2006;44:136-44
Clinical Outcome after Ilio-femoral Stenting
Alone in Combined Chronic Venous Disease(NIVL 37%, PTS 63%)
Number of limbs 528
C4-6 275 (52%)
Deep reflux 172 (33%)
+ superficial 343 (65%)
+ perforator 100 (24%)
Axial deep reflux 224 (42%)
Segmental reflux score ≥3/7 59%
Cumulative rate @ 5 y
Healed ulcer of C6 54%
Recurrent of C5 12%
Healed dermatitis 81%
Complete relief of
Pain 71%
Swelling 36%
QoL (CIVIQ 68-53) 20%
24 limbs (5%) had valve repair
Raju & Neglén, J Vasc Surg 2010;51:401-9
Ilio-femoral Venous StentingThrombotic Events(982 stented limbs)
Postop (<30days) 1.5%
Late (median 13m, range 2-77) 3%
Ipsilateral stented iliac vein (n=31) 3%
Contralat iliac thrombotic event (n=11) 1%
Neglén et al. J Vasc Surg 2007;46:979
Etiology
Patency rateDuration
of f/uPrimary
Assist –
PrimSecondary
All 67-83% 89% 93% 6-8y
Primary (NIVL) 79% 100% 100% 6y
Postthrombotic
-non-occlusive38-57% 63-80% 74-86% 4-6y
Postthrombotic
- occlusion30-70% 56-73% 66-87% 4-6y
Stent patency rates and etiology
0 12 24 36 48 60 720
10
20
30
All Limbs
Thrombotic
Non-thrombotic
224 72 65 45 26 17494 216 141 93 56 33270 119 76 48 30 16
Months
Ra
te o
f In
-ste
nt
Re
ste
no
sis
(%
)
5%
1%
10%
Rate of In-stent Restenosis (>50%)
[SEM <10%]
Neglén et al. J Vasc Surg 2007;46:979
Stenting of the iliac venous outflow
– Is a safe procedure with low morbidity
and no mortality
– Is durable long-term
– Substantially relieves symptoms
Practical Implications for Management of
Chronic venous Disease
• CVD – think obstruction!
• Non-thrombotic iliac vein lesion (NIVL) is a frequent finding.
• Complement ultrasound scanning of the lower extremity with transfemoral venography, MRV, CT-V or IVUS
• Venous stenting - primary choice in the treatment of ilio-caval obstruction
• Venous stenting is the initial procedure when an iliofemoral venous obstruction is present whether or not it is associated with reflux
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