Disclosure Seshadri Raju, M.D.

I disclose the following financial relationship(s):

•Ownership Interest: Veniti Stock and Device Company

Non-Thrombotic Iliac Vein Lesions: Permissive Role in CVD

Pathogenicity

Seshadri Raju MD.FACS.

The Rane Center

Flowood. MS>

First description of Iliac vein compression 1908

Popularized by May and Thurner in 1957 Left side dominance noted.

Known as Cockett syndrome in UK (1967) His patients mostly young women involving left leg

“Classic lesion” beneath right iliac artery crossing. Traumatic, not thrombotic; congenital in some.

Not merely compression, but intraluminal webs also (NIVL)

NIVL

Diagnostic sensitivity of venography:≈50%

In 30% of NIVL cases venograms appear “normal” and the lesion is well hidden

IVUS IN NIVL WITH WEB

IVUS can measure area unlike in venography. 64 sq. mm in this case.

In adults CIV should measure ≥ 175 sq mm

With IVUS, NIVL occurs on both sides, both sexes and in all age groups.

Proximal and distal NIVL

Sensitivity of Diagnostic Techniques for Obstruction (IVUS Positive)

• Ascending Venography 245/386 63% • Collaterals Present 165/382 43% • Femoral V Pr > 3mmHG 20/133 15% (over opposite limb) • Exercise Fem V Pr 92/175 53% • Arm/Foot resting Diff 37/228 15% • Foot Pr (Reactive Hyper) 125/224 56% • Doppler- No Phasicity 250/423 59% • Diagnostic IVUS is recommended even if above

tests are negative.

How common is obstruction in primary reflux?

• May-Thurner type iliac vein lesions are common in the normal population. Recent MR studies show such lesions in ≈60% of the asymptomatic general population in silent form.

• IVUS positive obstructive lesions of the iliac vein are frequently present (>90%) in CEAP class 3 and higher “primary” reflux cases!

• Why?

Iliac Vein obstruction is a permissive pathology

J Vasc Surg 44: 136-143; 2006

• Iliac vein obstructive lesions are “permissive” ie. they remain silent till an additional or secondary insult precipitates symptoms.

• Therefore, there is “High Prevalence” in symptomatic patients.

• Permissive pathologies are ubiquitous in human diseases. Many examples. Classic PFO

• Rx of permissive pathology usually results in clinical relief. Repair of secondary insult is required only infrequently.

Examples of other permissive pathologies

Obesity & Diabetes

Diabetes & Neuropathy

Carotid stenosis & TIA

Ureteric reflux & pyelonephritis

PFO & Stroke

Esophageal reflux & Asthma

Barrett’s esophagus and cancer

Helicobacter and gastric ulcer

Stenting NIVL is curative even when associated reflux is uncorrected suggesting that

reflux may be a secondary insult.

Ulcer

Secondary Insults that may precipitate symptoms in the presence of a silent

iliac vein lesion. • Trauma

• Infection

• Reflux (incidence↑ age)

• DVT

• joint surgery

• Seated orthostasis and

Poor calf pump (elderly)

• Obesity

• Edematogenic meds.

• Postmenopausal hormonal changes

• Lymphatic damage from vein disease itself or from, cancer, radiation, chemo, surgery.

Trauma Cellulitis Joint Replacement

Postthrombotic focal stenosis Not readily apparent on venogram

Trabeculum

Postthrombotic lesions are also permissive

Remote DVT decades ago remaining silent till secondary insult precipitates symptoms.

IVUS/ILIAC VEIN STENTING: INDICATIONS

• Based on clinical considerations, not radiologic findings howsoever bad

• Pain, Swelling, Dermatitis/ulcer ie. advanced manifestations of CVI; Recurrent cellulitis is another indication.

• Failed conservative therapy.

“Venous Hypertension” syndrome: Orthostatic pain only symptom. Limb with normal appearance.

Leg swelling in old ladies is often neglected. NIVL or PTS lesions are often present. Leg swelling retards mobility

and self care. Bilateral lesions occur in ≈20% .

In the younger patient, swelling is a quality of life issue. Painful leg swelling is highly

symptomatic.

“Classic” clinical signs of lymphedema are unreliable; venous swelling can mimic them. Do IVUS!

30% of CVD cases will have secondary lymphedema due to use overload! Probably the commonest cause

of lymphedema in US

Why do iliac vein stents work? • Iliac veins are major outflow tracts and the

importance and incidence of obstruction has been underestimated due to diagnostic difficulties.

• Advanced CVI is multifocal pathology, comprising both obstruction and reflux in about 60%. (Pure obstruction in about 40%).

• CVI uniquely responds to partial correction ie. correction of either pathology often results in clinical relief.

Unexpected Major Role for Venous Stenting in Deep Reflux Disease:

Symptom Relief with Partial Correction of Pathology. Raju S, Darcey RL, Neglén P

J Vasc Surg 51: 401-408; 2010.

• We stented iliac vein obstruction in combined obstruction/reflux in 528 limbs with plans for reflux repair later.

• Clinical relief from initial stenting was unexpectedly good and correction of the remaining reflux was not necessary.

Stent Outcome is good even if reflux is present and uncorrected

n=528 Limbs Reflux Distribution

Deep Reflux only 32%

Deep and Suprfl 68%

Perforator 21%*

*(all with Deep or D/S Reflux)

_____________________

Axial Reflux 42%

Reflux Segmnt Score**

Mean 2.9 ± 1.5 **1 each for Fem, Prof, Pop, Prox

GSV, Distal GSV, SSV and Perf.

Maximum Possible 7

_________________Reflux segment Score of >3 in 58%

REFLUX PARAMETERS

Pre-Stent Post-Stent

Test median (r) N median (r) N P

% Drop 62 (0-100) 403 64 (19-100) 134 0.37 VFT 16 (1-123) 400 18 (2-160) 132 0.41 VFI90 2.8 (0-16.6) 473 2.2 (0-14.1) 209 0.02* *significant

Reflux was unchanged or improved but did not worsen

after stenting.

STENT PATENCY J Vasc Surg 46: 979-990, 2007

0 6 12 18 24 30 36 42 48 54 60 66 720

10

20

30

40

50

60

70

80

90

100

Primary

Assisted-primary

Secondary

603 383 290 243 195 165 139 114 88 69 53 34603 381 287 242 195 165 139 114 88 69 53 34603 373 267 218 176 143 113 90 68 52 39 24

Months

Pa

ten

cy

Ra

tes

(%

)

93%89%

67%

0 6 12 18 24 30 36 42 48 54 600

10

20

30

40

50

60

70

80

90

100

148 86 70 55 46 37 31 24 20 15

Months

Lim

bs

wit

h H

ea

led

Ulc

ers

(%

)Ulcer Healing

58%

0 6 12 18 24 30 36 42 48 54 600

20

40

60

80

100

Pain - Complete relief

Pain - Complete and partial relief (Reduction 3 on VAS)

Swelling - Complete relief

Swelling - Complete and partial relief (improvement 1 degree)

Months

Cu

mu

lati

ve

Sy

mp

tom

Re

lie

f (%

) Relief of Pain and Swelling; n=982 limbs

74%

62%

65%

32%

[SEM <10%]

QOL (CIVIQ) improved in every category

Pre-Stent Post-Stent P

n=395 n=179

Pain 3 (1-5) 3 (1-5) <.0001*

Work 4 (1-5) 3 (1-5) <.0001*

Sleep 3 (1-5) 2 (1-5) <.0003*

Social 3.25 (1-5) 2.625 (1-5) <.0001*

Morale 2.778 (1-5) 2.556 (.9-5) <.0029*

Total 66 (20-100) 53 (20-100) <.0001*

*significant

UMC VALVULOPLASTY PROGRAM ’80s

0

50

100

150

200

250

1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007

Year

Nu

mb

er

of

inte

rve

nti

on

s

Valve repair Venous Stentings

END