Embolic Protection Devices

1
Embolic Protection Devices

• Jay S. Yadav M.D.
• Director, Vascular Intervention
• Department of Cardiovascular Medicine
• The Cleveland Clinic Foundation

2
Everyone Embolizes
Pettelot, et al. Circ 971522, 1998
ejt 048114
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
The Hot Vessel
Microvascular Obstruction
5x
1000x
ejt 029144
5
IIb/IIIa ? in Acute MI
? Microvascular Perfusion
p 0.024
p 0.15
From baseline to day 14
ejt 106 2110
Neumann, et al. Circ 9826952701, 1998
6
(No Transcript)
7
(No Transcript)
8
(No Transcript)
9
Transcranial Doppler (TCD)
EMBOLI
MIDDLE CEREBRAL ARTERY VELOCITY CM/SEC
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 27463-71
YADAV
12
Ex-Vivo Carotid Plaque Embolization Model
Number of emboli and lesion characteristics
Ohki T et al. J Vasc Surg 1998 27463-71
13
Why Are There Not More Strokes With Carotid
Stenting?

• Rapp et al J Vasc Surgery 20003268-76
• Ex vivo carotid plaque PTA
• Particles injected into Rat ICA
• Grp A lt200 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 20003268-76

• Most particles released during PTA/Stenting
• lt200 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
Results
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
22
EPI
1st Generation 3.9F sheath - 0.014 Wire

• Universal Application
• Uninterrupted blood flow
• ( 80µm pores )

• Capture Efficiency
• Particle Retention
• Trackability Flexibility
• One to One Torquability
• Radiopacity
• Withdraws into 0.035 angioplasty balloon

23
E-TRAP FILTER (MSD)
24
Microvena Trap
4.0mm
2.5mm
7.0mm
DeviceWire Offered in 2.5, 3.0, 3.5, 4.0, 5.0,
6.0, and 7.0 mm basket diameters.
Sizes Nominal
25
PercuSurge Guard Wire

• SAFER trial
• SVGs 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 _at_ 3.2 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
Current 4 mm _at_ 4.6 F profile
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
Average of filter surface covered with embolic
particles
Range 0-80
Range 0-60
Range 5-50
38
Embolic Particle Size
Maximum particle size recovered
39
Embolic Particle Size
Average particle size recovered
40
Coronary
SVG
E. Grube Siegburg, GR
Carotid
41
Material Recovered during PTCA
42
SAPPHIRE RCT Registry

• 30 Centers
• 600 - 900 RCT
• 400 Registry
• 30 patients per center

43
SAPPHIRE

• Asymptomatic gt80
• Symptomatic gt70
• RCT
• High risk

44
SAPPHIRE Profile of high risk patients in trial

• CHF class III/IV and / or LVEF lt30
• Open heart surgery W/I 6 weeks
• Recent MI (gt24hrs lt4weeks)
• Unstable angina (CCS class III/IV)
• Synchronous severe CAD and carotid disease
• Severe pulmonary disease (FEVlt1.0)

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
SapphireStatus 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
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 Emboli Prevention
Devices?