Micromesh and dual layer carotid stent technology

What does it add to procedural safety of CAS?

Koen Deloose, MD

Head of Vascular Surgery, AZ Sint Blasius

Dendermonde, Belgium

2ID3 Medical – 2017 |

Disclosure slide

I have the following potential conflicts of interest to report:

Consulting: Medtronic, Spectranetics, Biotronik, Abbott, Bard

iVascular, Bentley, Cook, GE Healthcare

Employment in industry

Stockholder of a healthcare company

Owner of a healthcare company

Other(s)

I do not have any potential conflict of interest

Speaker name: Koen Deloose, MD

Long term CREST results…

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6.2%@ 4yrs

11%@ 4yrs

3.9%

@ 30days

9.6%

@

30days

8.5%

@ 2yrs

9.2%

@ 2yrs

6.3%

@ 30days

6.8%

@ 30days

CEA CAS CEA CAS

EVA-3S SPACE

Same “long term” findings in EVA-3S and SPACE

THE DIFFERENCE IS HERE!!

Room for periproceduralimprovement D0 -> D31

Free

do

mo

f M

AN

E

t

OK !

Timeline (days)

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Post procedural

• Scaffolding Stent

Per-procedural• Technique improvement

• Operator experience

• Patient selection

• Lesion selection

• EPD improvements

• Scaffolding Stent

Room for periproceduralimprovement D0 -> D31

We need better protection againstSMALL & LATE embolisation

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We need better protectionagainst SMALL emboliMultiple small hits are nowadays more determining

the final result than the earlier one big hit.

We need better protectionagainst SMALL emboli

CREST data

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We need better protectionagainst SMALL emboli

10

SDR 3,6%

BIC study : Belgian Italian Carotid study

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We need better protectionagainst SMALL emboli

open cell / large free

cell area

Closed cell

Jansen O et al. Stroke 2009; 40:e-pub Jan 15

SPACE does confirm these findings!!!

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We need better protectionagainst SMALL emboli

Schnaudigel et al. Stroke 2008 ; 39 : 1911-1919 Park et al. J Neurosurg 2013;119

Prospective RCT : MRI hitsClosed vs Open Cell Stents

Leal et al. EJVES 2010;39:661

Most are temporary, not associated withneurologic deficits

Unclear if there will be an associatedlong-term cognitive deficit

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We need better protectionagainst LATE emboli

By courtesy of NL Hopkins, presented at Euro PCR

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We need better protectionagainst LATE emboli

Majority of strokes occur post-procedure (+/- 2/3)

15

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We need better protectionagainst LATE emboli

16Hill et al. Circulation 2012;126:3054

• CREST timing of Stroke after CAS

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We need better protectionagainst LATE emboli

17

Late SDR 1,9%

BIC study : Belgian Italian Carotid study

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We need better protectionagainst SMALL & LATE emboli…

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…We need a sustained “embolicprotection device”….

With the courtesy of Stephan Muller Hulsbeck, presented @LINC 2017, Leipzig, Germany

375 µ 500µ 1050µClosed cell stent

1900µ Open cell stent

ROADSAVER

CGUARD

GORE CAROTID STENT

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Cguard (Inspire MD)

• Nitinol stent with a MicroNet (a biostable meshwoven from a single strand of 20 µm Poly EthyleneTerephtalate (PET) : pore size 165µm

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Cguard (Inspire MD)STUDY N pts Procedural

success (%)30 day SDR (%) New ipsilateral

DWI MRI lesionspost proc (%)

(1)CARENET 30 100 0 37(30d MRI showed

complete resolution of all but 1)

(2)IRON GuardMultiCenterItalian Registry

165 98,8 2,5 19,6(61/165 underwent

DWI MRI)

(3) Wissgott et al 30 100 0 0(19/30 underwent a

30 d DWI MRI without new lesions)

(4) Paradigm 101 101 99,1 0,9 na

1.Schofer J et al. JACC CardioVasc Interv. 2015, Aug ;8(9):1229-342.Setacci C et al. J CardioVasc Surg 2015;56:787 & update presentation @LINC2017, Leipzig,Germany3.Wissgott C et al. J Endovasc Ther. 2016 Oct 124. Musialek P et al. Eurointervention 2016;12:e658-70 & update presentation @TCT2016

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Roadsaver Stent (Terumo)

• Nitinol interwoven stent (180 µm struts) covering a woven mesh of thinner nitinol wires (42 µm). Additionally, inner mesh and outer stent are connected on several spots with 45 µm thick wires : pore size 165µm

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Roadsaver stent (Terumo)STUDY N pts Procedural

success (%)30 day SDR (%) New ipsilateral

DWI MRI lesionspost proc (%)

(1)FlensburgRoadsaverexperience

62 100 3,2 na

(2)Ruffino et al 23 100 0 30(30 days DWI MRI showed complete

resolution )

(3) RoadsaverItalian Registry

150 100 0 0,6

(4) CLEAR ROAD 100 99,1 2,1 na

1.Hopf-Jensen S et al. JEVT 2015; 22(2) : 220-2252.Ruffino et al. Cardiovasc intervent Radio 2016;39:15413.Nerla et al. EuroIntervention 2016:12(5) aug 54.Bosiers et al. EuroIntervention 2016 May; 17:12(1) & Presented @LINC2017, Leipzig, Germany

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GORE carotid Stent (Gore)

• Open cell nitinol stent covered by a closed cell PTFE lattice, both with CBAS Heparin coating :

pore size 500µm

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GORE carotid stent (Gore)

STUDY N pts Proceduralsuccess (%)

30 day SDR (%) New ipsilateralDWI MRI lesions

post proc (%)

SCAFFOLD trial 312(enrolmentcomplete)

30 days results will be presented @CX2017

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Conclusion

• Post 30 day results of CAS are as good as CEA

• Room for improvement first 30 days : we need toprotect against smaller and later emboli!!!

• New stent designs play here an important role : micromesh or double layer stents are “sustainedembolic protection devices”

• Several clinical trials, although not randomized yet, show very promising results

Micromesh and dual layer carotid stent technology

What does it add to procedural safety of CAS?

Koen Deloose, MD

Head of Vascular Surgery, AZ Sint Blasius

Dendermonde, Belgium