Correct stent selection in symptomatic carotid...
Transcript of Correct stent selection in symptomatic carotid...
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%