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