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Embolic protection devices
1. Embolic Protection DevicesEmbolic Protection Devices
Jay S. Yadav
M.D.
Director,
Vascular
Intervention
Department of
Cardiovascular
Medicine
The Cleveland
Clinic Foundation
11. Embolic Particles were generated from each plaque
Ex-Vivo Carotid Plaque Embolization Model
Ohki T et al. J Vasc Surg 1998; 27:463-71
YADAV
12. Ex-Vivo Carotid Plaque Embolization Model
Ohki T et al. J Vasc Surg 1998; 27:463-71
Number of emboli and lesion characteristics
Echolucent
0
25
50
75
100
125
Echogenic
Numberofparticles
p=0.012
Numberofparticles
0
25
50
75
100
125
50 60 70 80 90 100
% Stenosis
13. Why Are There Not More
Strokes With Carotid Stenting?
Rapp et al J Vasc Surgery 2000;32:68-76
Ex vivo carotid plaque PTA
Particles injected into Rat ICA
Grp A: <200 u 100 particles
Grp B: 200 to 500 u 100 particles
50 atheroemboli / gram of brain
Human brain 1300 g, rat brain 2 g
14. Rapp et al J Vasc Surgery 2000;32:68-76
Most particles released during
PTA/Stenting
<200 u 200-500 u
Day 1 & 3 nl neuronal
isch
Day 7 neuronal ischemia
32. Reduced Delivery Profile
New 4 mm @ 3.2 F profile
Current 4 mm @ 4.6 F profile
Crossing Profiles
4 mm 3.2 F
5 mm 3.3 F
6 mm 3.5 F
7 mm 3.7 F
8 mm 3.9 F
Lubricious coating on delivery sheath
44. SAPPHIRE: Profile of high risk
patients in trial
CHF class III/IV and / or LVEF <30%
Open heart surgery W/I 6 weeks
Recent MI (>24hrs <4weeks)
Unstable angina (CCS class III/IV)
Synchronous severe CAD and carotid
disease
Severe pulmonary disease (FEV<1.0)
45. SAPPHIRE: Profile of high risk
patients in trial
Contralateral carotid occlusion
Contra. laryn palsy; post-rad Rx, prev. CEA
CCA lesions below clavicle
High cervicl ICA
Severe tandem lesions
46. Sapphire
Status of Patient Entry
Total enrollment
– 715 pts -
Randomized
– 312 pts
Stent registry
– 400 pts (closed)
Surgical registry
– 3
49. Guidant ACCUNET™ Embolic Protection System
Filter Basket Specifications
Polyurethane filter
over Nitinol basket
Diameters: 4-8 mm
Filter pore size ≤
120 microns
Designed to maintain
perfusion
Caution: Investigational device. Limited by Federal (U.S.) Law to investigational use.
51. Conclusions
Definite Role for Emboli Prevention
Devices in Coronary and Peripheral
Intervention
Selective and Data Driven
Most Compelling for Carotids, SVGs, MI,
Renals
52. GPIIb/IIIa Inhibition and EmboliGPIIb/IIIa Inhibition and Emboli
Prevention Devices?Prevention Devices?