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Correct stent selection in symptomatic carotid artery
diseaseKoen Deloose, MD
Head Dpt Vascular Surgery
AZ Sint Blasius, Dendermonde, Belgium
2iD3 Medical – 2017 |
Case presentation : 74yr, male
• Medical history 2007 Right FP1-bypass
2010 CABG
2015 PTAS left SFA
2016 DCB distal anastomosis right bypass
• Risk factorsSmoking, hypercholesterolemia
• Present stateSpeech difficulties & numbness right arm/hand during 8
hours, completely recovered afterwards
3iD3 Medical – 2017 |
Case presentation : 74yr, male
• Duplex ultrasound Peak systolic velocities ~ 450 cm/sec
mixed lipid-fibrotic plaque, moderate
echolucent, GSM < 15
• Diffusion weighted MRIshows a frontal subcortical high signal
intensity lesion
4iD3 Medical – 2017 |
Case presentation : 74yr, male
• MRI angio carotid vessels
• What to do?
5iD3 Medical – 2017 |
Case presentation : 74yr, male
• What to do?
• CAS – CEA – Anti-platelet therapy?
• If CAS, access?
• If CAS, protected or unprotected? Which EPD? Which guide wire?
• Predilation? Protected? Unprotected?
• If CAS, which stent? Why?
6iD3 Medical – 2017 |
Case presentation : 74yr, male
• What to do?
• CAS
• Right femoral access
• JB2 catheter (Cordis°) with soft, curvedGlidewire 035”, 260 cm (Terumo°)
• Discovery 740 + Vessel Assist (GE°)
7iD3 Medical – 2017 |
Vessel ASSIST offers a Bi-view registration mode:
3D model registration with 2 simultaneous displayed, different angled (Accuracy Score), fluoroscopic images
2D-3D Registration at tableside by translating/rotating on correct landmarks (Calcium, bone, previous stents…)
GUIDE YOUR PROCEDURE WITH VESSEL ASSIST
8iD3 Medical – 2017 |
Vessel ASSIST offers a Bi-view registration mode:
2D-3D Registration at tableside by translating/rotating on correct landmarks (Calcium, bone, previous stents…)
Getting access to the left CCA and position a stable 6F, 90 cm Destination sheath (Terumo°)
GUIDE YOUR PROCEDURE WITH VESSEL ASSIST
9iD3 Medical – 2017 |
Case presentation
• Destination 6F, 90cm (Terumo°)
• Spartacore 0,014” (Abbott Vascular°)
• Option for direct stenting, no EPDWHICH ONE ???
10iD3 Medical – 2017 |
Case presentation
• Roadsaver 8-30 (Terumo°)
11iD3 Medical – 2017 |
Case presentation
• Roadsaver 8-30 (Terumo°)
12iD3 Medical – 2017 |
Case presentation
• Patient stayed 60’ on recovery room
• Stayed overnight in the hospital
• Discharged 28 hours after procedure without anyneurological event and a perfect wall appositionedand patent stent
• Post procedural medication : Clopidogrel – ASA for3 months, afterwards lifelong ASA monotherapy
• FU : 1m, 6m, 12m, 24m, 36m
Room for periproceduralimprovement D0 -> D31
Free
do
mo
f M
AN
E
t
OK !
Timeline (days)
We need better protection againstSMALL & LATE embolisation
14iD3 Medical – 2017 |
We need better protectionagainst SMALL & LATE emboli…
15iD3 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 375µm
16iD3 Medical – 2017 |
…We need a sustained “embolicprotection device”….
With the courtesy of Stephan Muller Hulsbeck, presented @LINC 2017, Leipzig, Germany
375 µ 500µ1050µ
Closed cell stent
1900µ Open cell
stent
ROADSAVER
17iD3 Medical – 2017 |
CLEAR-ROAD study
Primary Endpoint30-day rate of Major Adverse Events (MAE), defined as thecumulative incidence of any peri-procedural death, stroke or myocardial infarction (≤30 days post-procedure)
Secondary Endpoints• Late ipsilateral stroke (D31 – D365)
• Technical succes rate & device malfunctions
• MAE by sub-group symptomatic/asymptomatic
• TLR – ISR
18iD3 Medical – 2017 |
Per Protocol MAE’s
All Death, Stroke, or MI 2.00%
Death 1.00%
Any Stroke 1.00%
- Major Stroke 0.00%
- Minor Stroke 1.00%
MI 0.00%
Results – 30 daysPrimary Endpoint: 30-day rate of MajorAdverse Events (MAE), defined as thecumulative incidence of any peri-procedural death, stroke* or myocardialinfarction (≤30 days post-procedure)
*Stroke is defined as an acute neurologic event with localsymptoms and signs lasting more than 24 hours consistentwith focal cerebral ischemia.
1 patient died at Day 4.
1 patient experienced an ipsilateralstroke (Day 12) because of AF and
inadequately anticoagulantia medication.
97.9%
19iD3 Medical – 2017 |
12-month freedom from MAE
90.7%
Ipsilateral Stroke 4 patients
Contralateral Stroke 1 patients
Death- due to M.I.- due to kidney failure
3 patients- 2 patients- 1 patient
20iD3 Medical – 2017 |
12-month freedom fromipsilateral stroke
time baseline 30 days 6MFU 12MFU Significant
Symptomaticat risk 31 30 29 28
P = 0.7797
% 100 100 100 96.6
Asymptomaticat risk 69 66 65 59
% 100 98.6 98.6 95.5
21iD3 Medical – 2017 |
12-month patency and TLR
92.5%
12 month Primary Patency is 92.5%
97.9%
12 month freedom from TLR is 97.9%