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The evolution of stent design related toThe evolution of stent design related to

carotid stenting strategycarotid stenting strategy

A. Cremonesi*, F. Castriota*A. Cremonesi*, F. Castriota*

(*) Interventional Cardio-Angiology Unit(*) Interventional Cardio-Angiology UnitVilla Maria Cecilia HospitalVilla Maria Cecilia Hospital

Cotignola (RA) - ItalyCotignola (RA) - Italy

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Back

ground

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Carotid protected procedureCarotid protected procedureDefinitionDefinition

CC engagementCC engagement

Stent selectionStent selection

& implantation& implantation

EPD selectionEPD selection

& management& management

Are anatomy and/orAre anatomy and/or

carotid plaque featurescarotid plaque featuresinfluencinginfluencing

indication and technicalindication and technical

aspect of CAS?aspect of CAS?

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Sub-occlusive soft lesionSub-occlusive soft lesion- Type III aortic arch -- Type III aortic arch -

Braided mesh structure

Proximal occlusion

Type of

carotid stent

Type of EPD

1. Management of massive distal

embolization

2. Prevention of plaque prolapse (lateevents)

Strategy endpoints

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Do we need evolution in stent design?Do we need evolution in stent design?

Self-expanding stent

technical features

Foreshortening

Conformability orflexibility

Vessel wall adaptability

Scaffolding & wall

coverage

Radial strength

Radial stiffness

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PerfectPerfect

BB

DD

CarotidCarotid StentingStenting StrategiesStrategies

A:A: Braided meshBraided mesh

B:B: Laser cut tube, closed cell designLaser cut tube, closed cell design

C:C: Segmented crown, open cell designSegmented crown, open cell design

D:D: Flat rolled sheet, closed cell designFlat rolled sheet, closed cell design

AA

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CC

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A. Cremonesi et al. EuroIntervention, December 2005

Analysis on 377 consecutive patients

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Late embolic events: dynamicsLate embolic events: dynamics

Our main future task must be to improve:Our main future task must be to improve:

Carotid plaque characterizationCarotid plaque characterization, to, to tailortailor both the indicationboth the indicationand the endovascular procedureand the endovascular procedure

Stent performancesStent performances, to promote a, to promote a realreal material bio-material bio-compatibility andcompatibility and specific intrinsic anti-embolic propertiesspecific intrinsic anti-embolic properties,,therefore protecting patients and not only procedurestherefore protecting patients and not only procedures

1.1. Late embolic events occur in the post-procedure period, betweenLate embolic events occur in the post-procedure period, between

stent implantation and its complete re-stent implantation and its complete re-endotelizationendotelization (3-4 weeks).(3-4 weeks).

2.2. Late symptomatic embolic events depend mostly on prolapsed softLate symptomatic embolic events depend mostly on prolapsed soft

tissue as well as platelet micro-aggregates / thrombi detached fromtissue as well as platelet micro-aggregates / thrombi detached from

the stent metallic framethe stent metallic frame

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Scaffolding andScaffolding and

wall coveragewall coverage

Scaffolding: amount of support a

stent gives to the vessel

wall at the lesion site

Wall coverage: ratio between quantity of

stent material in

comparison to amount of

vessel tissue

Less plaque prolapse

More scaffolding More wall coverage

Plaque coveringPlaque covering

Long acting plaqueLong acting plaque

prolapse preventionprolapse prevention

Closed cell geometry stentClosed cell geometry stent

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High grade soft ulcerated lesionHigh grade soft ulcerated lesion- Type I/II aortic arch, RCCA occluded -- Type I/II aortic arch, RCCA occluded -

Braided mesh

Filter wire + proximal

occlusion

Type of

carotid stent

Type of EPD

1. Prevention of massive distal

embolization

2. Prevention of plaque prolapse (lateevents)

Strategy endpoints

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High grade soft ulcerated lesionHigh grade soft ulcerated lesion- Type I/II aortic arch, RCCA occluded -- Type I/II aortic arch, RCCA occluded -

MO.MA:MO.MA:

ECA stop flow blockageECA stop flow blockageECA stop flow blockageECA stop flow blockage

EPI EZ filter-wire in ICAEPI EZ filter-wire in ICA

CCA+ECA stop flow blockageCCA+ECA stop flow blockage

EPI EZ filter-wire in ICAEPI EZ filter-wire in ICA

Carotid Wallstent 9/30 mmCarotid Wallstent 9/30 mm

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High grade soft ulcerated lesionHigh grade soft ulcerated lesion- Type I/II aortic arch, RCCA occluded -- Type I/II aortic arch, RCCA occluded -

Total occlusion timeTotal occlusion time

72 seconds72 seconds

Plaqu

ecoveri

ng

Plaqu

ecoveri

ng

Long

actin

gplaque

Long

actin

gplaque

prolap

sepre

vention

prolap

sepre

vention

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From a flat Nitinol sheet

2005: Evolution in Carotid Artery Stenting2005: Evolution in Carotid Artery Stenting

NexStentNexStent

to a rolled stent without sealing joints

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Dynamic Tapering ConceptDynamic Tapering Concept

CylindricalCylindrical

StentStent

NexstentNexstent

TaperedTapered

StentStent

Tapered byTapered bydesigndesign

SelfSelfTaperedTapered

Static TaperingStatic Tapering

Dynamic TaperingDynamic Tapering

Size dynamicSize dynamic

4-9 mm4-9 mm

MorphoMorpho

dynamicdynamic

AnatomicAnatomic

conformabilityconformability

RadialRadial

strengthstrength

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CABERNET Trial

Clinical efficacy

450 patients enrolled

30-day composite end-point (death, stroke, MI): 3.8%

The Next Era in Carotid Artery StentingThe Next Era in Carotid Artery Stenting

NexStent

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NexStentNexStent drawbaksdrawbaks

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Need of stent evolution in theNeed of stent evolution in the

clinical practiceclinical practice

Incidence of risky carotid plaques in the

endovascular daily work:

Echolucent plaques

Plaque erosion / ulceration

Vulnerable plaque

Establish the need ofEstablish the need of

new generation stents withnew generation stents with

intrinsic anti-embolic propertiesintrinsic anti-embolic properties

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Carotid angioplasty and stenting:

lesion related treatment strategiesA.Cremonesi, F.Castriota, C. Setacci et al .EuroIntervention Dec. 2005

11,4143Contralateral carotid occlusion

31,30118Bilateral carotid disease >70%

S.D. 918Lesion length mmS.D. 681Diameter stenosis %

46,68176Left carotid artery

53,32201Right carotid artery

%No.Angiographic evaluation:

0,271Carotid post-PTA/stenting restenosis

8,4932Carotid post-endarterectomy restenosis91,51345Carotid de-novo lesion

S.D. 8,471Age

29,97113Female

70,03264Male

100,00377Population study

%No.Clinical data and angiographic evaluation

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Neurological historyNeurological history

Plaque characteristicsPlaque characteristics

35,28133Asymptomatic Patients

64,72244Symptomatic Patients

%No.Neurological history

35,54134Erosion / Ulcer

13,7952Severe calcifications

%No.Echo plaque complexity

30,77116Uniformly echogenic

25,7397Predominantly echogenic

22,8186Predominantly echolucent

20,6978Uniformly echolucent

%No.Echo plaque characteristics

Plaqu

ecove

ringandlo

ngac

ting

Plaqu

ecove

ringandlo

ngac

ting

plaqu

eprol

apseprev

ention

plaqu

eprol

apseprev

ention

need

edint

hema

jority

needed

inthe

majority

ofunse

lected

cases

ofunse

lected

cases

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Self-expandable stent inventorySelf-expandable stent inventory

0,261Smart Precise - Cordis

0,261Conformex - Bard

2,349Proteg - ev3

4,4217Exponent - Medtronic

7,0127Xact - Abbott

34,55133Acculink - Guidant

51,17197Carotid Wallstent - Boston Scientific

%No.Self expandable stents: 385

Plaqu

ecove

ringand

longa

cting

Plaqu

ecove

ringand

longa

cting

plaqu

eprol

apsep

reventio

n

plaqu

eprol

apsep

reventio

nsten

tsste

nts

usedin

58,08

%

usedin

58,08

%

ofunsel

ected

cases

ofunsel

ected

cases

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Do we need carotid stent evolution?Do we need carotid stent evolution?ConclusionConclusion

The ideal stent design doesnt exist at

the moment.

The carotid lesion characteristicsshould be always the reference point

for a rational decision making.

Late embolic events are still now an

unsolved problem: stent scaffoldingmight be the right solution.

Material and devices evolutionMaterial and devices evolution

should be driven always byshould be driven always by

treatment strategy needstreatment strategy needs