Micromesh and dual layer carotid stent technology What does it … · Disclosure slide I have the...
Transcript of Micromesh and dual layer carotid stent technology What does it … · Disclosure slide I have the...
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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
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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
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Long term CREST results…
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5ID3 Medical – 2017 | 5
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!!
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Room for periproceduralimprovement D0 -> D31
Free
do
mo
f M
AN
E
t
OK !
Timeline (days)
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7ID3 Medical – 2017 |
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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8ID3 Medical – 2017 |
We need better protectionagainst SMALL emboliMultiple small hits are nowadays more determining
the final result than the earlier one big hit.
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We need better protectionagainst SMALL emboli
CREST data
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10ID3 Medical – 2017 |
We need better protectionagainst SMALL emboli
10
SDR 3,6%
BIC study : Belgian Italian Carotid study
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11ID3 Medical – 2017 | 11
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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12ID3 Medical – 2017 |
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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14ID3 Medical – 2017 |
We need better protectionagainst LATE emboli
By courtesy of NL Hopkins, presented at Euro PCR
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15ID3 Medical – 2017 |
We need better protectionagainst LATE emboli
Majority of strokes occur post-procedure (+/- 2/3)
15
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16ID3 Medical – 2017 |
We need better protectionagainst LATE emboli
16Hill et al. Circulation 2012;126:3054
• CREST timing of Stroke after CAS
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17ID3 Medical – 2017 |
We need better protectionagainst LATE emboli
17
Late SDR 1,9%
BIC study : Belgian Italian Carotid study
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18ID3 Medical – 2017 |
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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20ID3 Medical – 2017 |
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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21ID3 Medical – 2017 |
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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22ID3 Medical – 2017 |
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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23ID3 Medical – 2017 |
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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24ID3 Medical – 2017 |
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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25ID3 Medical – 2017 |
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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26ID3 Medical – 2017 |
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
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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