VASCULAR STENTS

Gemma C. Ryder
g.c.ryder@qmul.ac.uk
What is a Stent?
 A small tubular mesh usually made of either
stainless steel or Nitinol.
 Inserted into stenotic arteries to keep the lumen
patent often used after PTCA.
 Used at various sites including the coronary,
renal, carotid and femoral arteries.
 Non-arterial uses e.g. in bronchus, trachea,
ureter, bile duct.
Current stent designs

Palmaz, the market leader

 Palmaz “Corinthian” Iliac
artery stent

Gianturco-Roubin II Stent
History
 The concept of vascular stents is accredited to
Charles Dotter in 1969, who implanted stainless
steel coils in canine peripheral arteries.
 Not followed up in humans because of
haemodynamically significant narrowing.
 Not in clinical practice until 1980s.
 Market leader is the Palmaz stent designed by
Julio Palmaz in 1985.
 Initially, 18 grafts placed in canine vessels, with
patency rates approaching 80% at 35 weeks.
Plaque Formation and
Morphology
 Smoking, high BP, toxins etc cause damage to the
vascular endothelium.
 LDL and fibrin pass through and collect in the sub-
endothelium.
 Monocytes adhere to the damaged endothelium, migrate
to the sub-endothelial space and engulf LDL – FOAM
CELLS.
 SMC migration and CT formation.
 Two main types of plaque:
 Atheromatous (athere: gruel, oma: tumour)
 Fibrous (like atheroma but with connective tissue cap)
CVD statistics
 Heart and circulatory disease is the UK's biggest
killer. 
 In 2001, cardiovascular disease caused 40% of
deaths in the UK, and killed over 245,000 people.
 Coronary heart disease causes over 120,000
deaths a year in the UK: approximately one in
four deaths in men and one in six deaths in
women.
Revascularisation techniques
 Coronary Artery Bypass Graft (CABG)
 Percutaneous Transluminal Coronary
Angioplasty (PTCA)
 Stents
CABG
 Major surgery
 Complications
 Stroke
 Mediastinitis (1-4%)
 Renal dysfunction (8%)
PTCA
 Minimally invasive procedure
 Percutaneous access either in the brachial or
femoral arteries.
 A guide wire is advanced to the stenotic region.

 A balloon is advanced along the wire and

inflated/deflated several times to fracture the
plaque and open the lumen.
Complications of PTCA
 Plaque rupture, may lead to:
 Thrombus formation
 Intimal flap
 Arterial rupture
 Acute closure
 Sub-optimal result
 Restenosis
 Requires further intervention to make vessel patent
Stenting vs. PTCA
 Prevents acute closure
 Tacks back intimal flaps
 Less restenosis:
 30–50 % restenosis with PTCA (coronary arteries).
 Coronary stents are associated with fewer repeat
revascularisation procedures
 Rates of death and MI are low and are not
significantly different between stents and PTA.
Stent Failure

Restenosis
20-30 %
Mechanism of Restenosis
 shear stress
 Intimal Hyperplasia

  lumen

  shear stress

 If baseline shear stress not restored –

continuing intimal hyperplasia and
RESTENOSIS
Factors Which Contribute to In-
stent Restenosis
 Thrombus/platelet/fibrin adherence to stent
struts.
 Metabolic disorder/smoking/atherogenic
diet.
 Small lumen diameter.
 Stress concentration at end of stent.
 Flow disturbance within stented region.
Thrombus in Human Coronary Artery
P re v io u s flo w s tu d ie s
o f P a lm a z s te n ts E n d s y s to le

P e a c o c k e t a l. (1 9 9 5 ) u s e d h o t
film p r o b e d is ta l to s te n t;
fo u n d f lo w d is tu r b a n c e u n d e r
m ild e x e r c is e c o n d itio n s .

F lo w

B e r r y e t a l. (1 9 9 7 ) p e r fo r m e d D ia s to le
d y e in je c tio n f lo w v is u a liz a tio n
a n d f o u n d s ig n if ic a n t flo w
d is tu r b a n c e w ith in a n d d is ta l to
s te n t; s ta g n a tio n n e a r s tr u ts .
 Effects of com pliance m ism atch

A brupt C om pliance
m ism atch creates:

Compliance
P ressure W ave R eflections

F low instability

W all Stress concentration

A xial Position
Improving Vascular Stents (1)
 Thrombus
 Anticoagulants
 Heparin – systemically or coated on stent.
 Inhibition of the GP IIb-IIIa receptor:

– Prevents platelet aggregation.

– Available as Abciximab.
– Associated with incidence of MI.
 PTFE coated stents.
 Intimal hyperplasia in
stented Canine iliac artery.

After insertion of stent

plus PTFE graft
material.
Improving Vascular Stents (2)

 Small diameter artery

 Combination of local and systemic medication and
covered stents.
 Intimal hyperplasia
 Brachytherapy:
 Use of ionising radiation to stop cellular proliferation.
 Delivery: Radioactive stents, catheter radiation.
 10% restenosis but may cause necrosis.
 Anti-proliferative agents e.g. rapamycin (Sirolimus)
Improving Vascular Stents (3)
 Mechanical and flow disturbances:
 Compliance Matching Stent (CMS)
 This stent is rigid in the middle and becomes more
compliant near its ends.
 This compliance is achieved by parabolic and

cantilevered struts.
 The middle struts are straighter, providing some

resistance to recoil and support for the

atherosclerotic plaque.
Compliance Matching Stent
Parabolic and canti-
levered struts cause
ends to be most
compliant.

Straighter struts in
middle provide stiff
support for plaque.

Transition in between.
Compliance Matching Stent
 The gradual change from rigid to compliant
with the CMS reduces stress concentration
at the stent edges.
 The geometry of this stent also fosters
more laminar flow through the stent.
 Less flow disturbance means less intimal
hyperplasia.
Compliance Testing
 String apparatus
 Finite Element Analysis
 C o m p lia n c e T e s t (s tr in g a p p a r a tu s )
6

5
Sl ope = 1. 87

4
Deflection

Sl ope = 0. 77
3
eformation (mm)

2
D

1 Sl ope = - 0. 01

Sl ope = - 0. 02
0
0 1 2 3 4 5

-1
Load ( N)
In Vitro Diameter Compliance Measurements

CMS
Palmaz
1
Normalized Compliance

0.5

0
0 6 12 18 24 30 36 42
Axial Position (mm)
E n d s y s to le

F lo w

D ia s t o le
 1.44-01

1.35-01

1.16-01

1.25-01

1.06-01

9.70-02

8.76-02

7.82-02

6.89-02

5.93-02

4.99-02

4.05-02

3.11-02

2.17-02

1.23-02

2.91-03

1.2
6 week post implantation

Palmaz CMS
Normal Stent vs. CMS
 Normal Stent  CMS
 Flow disruption  More laminar flow
 Disturbed shear stress  Less disturbed shear
 Intimal hyperplasia stress
 No return to baseline  Less intimal
shear hyperplasia
 RESTENOSIS  Return to baseline
shear
 PATENT LUMEN
My PhD Project
 Involves in vivo testing of the CES.
 Comparison with SMART stent:
 Amount of intimal hyperplasia.
 Effects on flow and pressure waves.

 Quantifying effect of “overstretch”.

 In vivo sites – carotid and iliac arteries.

Stents used in study
Pig femoral artery, overstretched by 25% and stented
– 1 month after procedure.