SHAPE Society

1. Embolic Protection DevicesEmbolic Protection Devices
Jay S. Yadav
M.D.
Director,
Vascular
Intervention
Department of
Cardiovascular
Medicine
The Cleveland
Clinic Foundation

2. Everyone Embolizes
ejt 048–114
Pettelot, et al. Circ 97:1522, 1998Pettelot, et al. Circ 97:1522, 1998

3. Embolization
Common and under recognized
CABG 6% stroke
CEA 3-10%
SVG PTCA 4-18% NQMI
Coronary Intervention 9%?
Arterial Thrombolysis 6-20% foot ischemia
Venous Thrombolysis 5-20% pulm embol
Mitral Valvuloplasty 1-28%
AAA stent grafting 5-11% foot ischemia

4. Acute Coronary Syndromes
ejt 029–144
The “Hot” VesselThe “Hot” Vessel
MicrovascularMicrovascular
ObstructionObstruction
1000x1000x
5x5x

5. BasalBasal PeakPeak
00
55
1010
1515
2020
2525
Heparin Alone, N=98
Abciximab, N=102
² * Coronary Flow Velocity (cm/s)² * Coronary Flow Velocity (cm/s)
IIb/IIIa ↓ in Acute
MI
ejt 106– 2110
↑↑ Microvascular PerfusionMicrovascular Perfusion
p = 0.15
* From baseline to day 14* From baseline to day 14
p = 0.024
Neumann, et al. Circ 98:2695–2701, 1998Neumann, et al. Circ 98:2695–2701, 1998

9. Transcranial Doppler (TCD)
MIDDLE
CEREBRAL
ARTERY
VELOCITY
CM/SEC
EMBOLI
BALLOON INFLATED DEFLATED

10. Ex-Vivo Carotid Plaque Embolization
Model - Ohki

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

15. Anti-Embolization Devices
Occlusive:
– Distal Flow Arrest
» Theron - Balloon Occlusion Catheter
» PercuSurge - Balloon Occlusion Guidewire
– Proximal Flow Arrest
» Arteria- Balloon Occlusion Guide
Catheter

16. Anti-Embolization Devices
Non-Occlusive:
– Supported Filters:
» AngioGuard - Guidewire Filter
» MedNova - Guidewire Filter
» Trap- Nitinol Filter
– Unsupported Filters:
» EPI- Guidewire Filter
» Etrap - Guidewire Filter

17. PercuSurge Guard Wire

18. AngioGuard XP

19. ArteriA PAEC

20. Arteria Proximal Flow Arrest - Parodi

21. External to internal carotid
flow during common carotid
Occlusion:
Baseline External Occlusion: 1 pt
ICA to ECA flow: 10 pts / 7.3 %
ECA to ICA flow: 62 pts / 84.9 %
Results:

22. 1st Generation 3.9F sheath - 0.014” Wire
Capture Efficiency
Particle Retention
Trackability & Flexibility
One to One Torquability
Radiopacity
Withdraws into 0.035” angioplasty balloon
Universal Application
Uninterrupted blood flow
( 80µm pores )
EPI

23. E-TRAP® FILTER (MSD)

24. DeviceWire
• Offered in 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, and 7.0 mm basket diameters*.
7.0mm
4.0mm
2.5mm
*Sizes Nominal
Microvena Trap

25. PercuSurge Guard Wire
SAFER trial
SVG’s randomized to regular wires vs
Percusurge
750 pts
60 centers

26. PercuSurge Guard Wire
Age 68
DM 35%
Class III/IV angina 75%
Lesion length 15 mm
Thrombus 38%

27. PercuSurge Guard Wire
PS No PS
TIMI III 98 % 94 %
No Reflow 3.4 % 8 %
Q MI 1.1 % 2.2 %
NQ MI 7.3 % 14.4 %
MACE 8.4 % 17.3 % p=.001

28. Acute MI
Belli, AJC,2000, TCT abstracts
20 pts AMI
Percusurge
17 primary PTCA, 3 rescue
All received Abciximab
Procedural success: 18/20
TIMI III: 14/20

29. Renal Artery Intervention
Henry, AJC, Oct 2000, TCT abstracts
30 renal arteries - 27 ostial
Percusurge
Technical Success: 30/30
Renal art occl time: 418 secs (149 - 797)
No renal fx deterioration at 6 months

30. Percusurge Renal Stent

31. Percusurge Renal Stent

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

33. AngioGuard XP

34. German Experience
Eberhard Grube, Siegburg, GR
21 patients :
–9 native coronary
–4 carotid bifurcation
–6 SVG

35. Cordis AngioGuard Clinical Data
Vessel diam 3.3 + 0.35 mm (2.8-5.8)
Stenosis 89% + 8.5% (70% - 95%)
Procedural Success 100%

36. Cordis AngioGuard Pathologic Data
U of Minnesota
Particles recovered from all patients
Number 147 + 111 (20 - 361)
Size (Area) 0.10 mm2
+ 0.5 mm2
(0.015-20)
Embolic Burden per pt:
37 mm2
+ 36 mm2
(0.6 mm2
- 110 mm2
)

37. Filter Surface Coverage
31 32
36
0
5
10
15
20
25
30
35
40
% Filter Surface Coverage
SVG Carotid Native Coronary
Average % of filter surface covered with embolic particles
Range 0-80Range 0-60Range 5-50

38. Embolic Particle Size
0
100000
200000
300000
400000
X-sectionalareaum^2
Largest
SVG Carotid Native Coronary
Maximum particle size recovered

39. Embolic Particle Size
0
10000
20000
30000
40000
X-sectionalareaum^2
Average
SVG Carotid Native Coronary
Average particle size recovered

40. Coronary SVG
Carotid
E. Grube
Siegburg, GR

41. Material Recovered during PTCA

42. SAPPHIRE RCT + Registry
– 30 Centers
– 600 - 900 RCT
– 400 Registry
– 30 patients per center

43. SAPPHIRE
– Asymptomatic >80%
– Symptomatic >70%
– RCT
– High risk

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

47. CREST - RCT
Symptomatic Patients (NASCET)
Enrolling 2500
– CEA vs. CS
– 60 Centers
– Enrollment - 40+ pts/center - 3 yrs

48. REGISTRIES
– ARCHER 300 pts
– EndoTex 300 pts
– Shelter 630 pts
– CARESS 2000 pts
– Maverick 400 pts

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.

50. CAROTID Trials
Trials Device D.P.D.
Sapphire 5F Precise Angioguard-ex
Crest 6F Acculink Accunet
Shelter 5.5 F Wallstent Percusurge
Caress 5.5 F Wallstent Percusurge
EndoTex 5F Nexstent TBA
Archer 6F Acculink Accunet
Maverick Medtronic-AVE Percusurge
Bard 7F Memotherm Trial Stopped
EPI

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?