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Embolic Protection DevicesEmbolic Protection Devices
Jay S. Yadav
M.D.
Director,
Vascular
Intervention
Department of
Cardi...
Everyone Embolizes
ejt 048–114
Pettelot, et al. Circ 97:1522, 1998Pettelot, et al. Circ 97:1522, 1998
Embolization
Common and under recognized
CABG 6% stroke
CEA 3-10%
SVG PTCA 4-18% NQMI
Coronary Intervention 9%?
Arterial T...
Acute Coronary Syndromes
ejt 029–144
The “Hot” VesselThe “Hot” Vessel
MicrovascularMicrovascular
ObstructionObstruction
10...
BasalBasal PeakPeak
00
55
1010
1515
2020
2525
Heparin Alone, N=98
Abciximab, N=102
² * Coronary Flow Velocity (cm/s)² * Co...
Transcranial Doppler (TCD)
MIDDLE
CEREBRAL
ARTERY
VELOCITY
CM/SEC
EMBOLI
BALLOON INFLATED DEFLATED
Ex-Vivo Carotid Plaque Embolization
Model - Ohki
Embolic Particles were generated from each plaque
Ex-Vivo Carotid Plaque Embolization Model
Ohki T et al. J Vasc Surg 1998...
Ex-Vivo Carotid Plaque Embolization Model
Ohki T et al. J Vasc Surg 1998; 27:463-71
Number of emboli and lesion characteri...
Why Are There Not More
Strokes With Carotid Stenting?
Rapp et al J Vasc Surgery 2000;32:68-76
Ex vivo carotid plaque PTA
P...
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...
Anti-Embolization Devices
Occlusive:
– Distal Flow Arrest
» Theron - Balloon Occlusion Catheter
» PercuSurge - Balloon Occ...
Anti-Embolization Devices
Non-Occlusive:
– Supported Filters:
» AngioGuard - Guidewire Filter
» MedNova - Guidewire Filter...
PercuSurge Guard Wire
AngioGuard XP
ArteriA PAEC
Arteria Proximal Flow Arrest - Parodi
External to internal carotid
flow during common carotid
Occlusion:
Baseline External Occlusion: 1 pt
ICA to ECA flow: 10 p...
1st Generation 3.9F sheath - 0.014” Wire
Capture Efficiency
Particle Retention
Trackability & Flexibility
One to One T...
E-TRAP® FILTER (MSD)
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
Micro...
PercuSurge Guard Wire
SAFER trial
SVG’s randomized to regular wires vs
Percusurge
750 pts
60 centers
PercuSurge Guard Wire
Age 68
DM 35%
Class III/IV angina 75%
Lesion length 15 mm
Thrombus 38%
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 ...
Acute MI
Belli, AJC,2000, TCT abstracts
20 pts AMI
Percusurge
17 primary PTCA, 3 rescue
All received Abciximab
Procedural ...
Renal Artery Intervention
Henry, AJC, Oct 2000, TCT abstracts
30 renal arteries - 27 ostial
Percusurge
Technical Success: ...
Percusurge Renal Stent
Percusurge Renal Stent
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 m...
AngioGuard XP
German Experience
Eberhard Grube, Siegburg, GR
21 patients :
–9 native coronary
–4 carotid bifurcation
–6 SVG
Cordis AngioGuard Clinical Data
Vessel diam 3.3 + 0.35 mm (2.8-5.8)
Stenosis 89% + 8.5% (70% - 95%)
Procedural Success 100%
Cordis AngioGuard Pathologic Data
U of Minnesota
Particles recovered from all patients
Number 147 + 111 (20 - 361)
Size (A...
Filter Surface Coverage
31 32
36
0
5
10
15
20
25
30
35
40
% Filter Surface Coverage
SVG Carotid Native Coronary
Average % ...
Embolic Particle Size
0
100000
200000
300000
400000
X-sectionalareaum^2
Largest
SVG Carotid Native Coronary
Maximum partic...
Embolic Particle Size
0
10000
20000
30000
40000
X-sectionalareaum^2
Average
SVG Carotid Native Coronary
Average particle s...
Coronary SVG
Carotid
E. Grube
Siegburg, GR
Material Recovered during PTCA
SAPPHIRE RCT + Registry
– 30 Centers
– 600 - 900 RCT
– 400 Registry
– 30 patients per center
SAPPHIRE
– Asymptomatic >80%
– Symptomatic >70%
– RCT
– High risk
SAPPHIRE: Profile of high risk
patients in trial
CHF class III/IV and / or LVEF <30%
Open heart surgery W/I 6 weeks
Recent...
SAPPHIRE: Profile of high risk
patients in trial
Contralateral carotid occlusion
Contra. laryn palsy; post-rad Rx, prev. C...
Sapphire
Status of Patient Entry
Total enrollment
– 715 pts -
Randomized
– 312 pts
Stent registry
– 400 pts (closed)
Surgi...
CREST - RCT
Symptomatic Patients (NASCET)
Enrolling 2500
– CEA vs. CS
– 60 Centers
– Enrollment - 40+ pts/center - 3 yrs
REGISTRIES
– ARCHER 300 pts
– EndoTex 300 pts
– Shelter 630 pts
– CARESS 2000 pts
– Maverick 400 pts
Guidant ACCUNET™ Embolic Protection System
Filter Basket Specifications
Polyurethane filter
over Nitinol basket
Diameters:...
CAROTID Trials
Trials Device D.P.D.
Sapphire 5F Precise Angioguard-ex
Crest 6F Acculink Accunet
Shelter 5.5 F Wallstent Pe...
Conclusions
Definite Role for Emboli Prevention
Devices in Coronary and Peripheral
Intervention
Selective and Data Driven
...
GPIIb/IIIa Inhibition and EmboliGPIIb/IIIa Inhibition and Emboli
Prevention Devices?Prevention Devices?
Embolic protection devices  yadav- cleveland clinic
Embolic protection devices  yadav- cleveland clinic
Embolic protection devices  yadav- cleveland clinic
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Embolic protection devices yadav- cleveland clinic

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Embolic protection devices yadav- cleveland clinic

  1. 1. Embolic Protection DevicesEmbolic Protection Devices Jay S. Yadav M.D. Director, Vascular Intervention Department of Cardiovascular Medicine The Cleveland Clinic Foundation
  2. 2. Everyone Embolizes ejt 048–114 Pettelot, et al. Circ 97:1522, 1998Pettelot, et al. Circ 97:1522, 1998
  3. 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. 4. Acute Coronary Syndromes ejt 029–144 The “Hot” VesselThe “Hot” Vessel MicrovascularMicrovascular ObstructionObstruction 1000x1000x 5x5x
  5. 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
  6. 6. Transcranial Doppler (TCD) MIDDLE CEREBRAL ARTERY VELOCITY CM/SEC EMBOLI BALLOON INFLATED DEFLATED
  7. 7. Ex-Vivo Carotid Plaque Embolization Model - Ohki
  8. 8. 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
  9. 9. 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
  10. 10. 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
  11. 11. 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
  12. 12. Anti-Embolization Devices Occlusive: – Distal Flow Arrest » Theron - Balloon Occlusion Catheter » PercuSurge - Balloon Occlusion Guidewire – Proximal Flow Arrest » Arteria- Balloon Occlusion Guide Catheter
  13. 13. Anti-Embolization Devices Non-Occlusive: – Supported Filters: » AngioGuard - Guidewire Filter » MedNova - Guidewire Filter » Trap- Nitinol Filter – Unsupported Filters: » EPI- Guidewire Filter » Etrap - Guidewire Filter
  14. 14. PercuSurge Guard Wire
  15. 15. AngioGuard XP
  16. 16. ArteriA PAEC
  17. 17. Arteria Proximal Flow Arrest - Parodi
  18. 18. 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:
  19. 19. 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
  20. 20. E-TRAP® FILTER (MSD)
  21. 21. 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
  22. 22. PercuSurge Guard Wire SAFER trial SVG’s randomized to regular wires vs Percusurge 750 pts 60 centers
  23. 23. PercuSurge Guard Wire Age 68 DM 35% Class III/IV angina 75% Lesion length 15 mm Thrombus 38%
  24. 24. 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
  25. 25. 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
  26. 26. 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
  27. 27. Percusurge Renal Stent
  28. 28. Percusurge Renal Stent
  29. 29. 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
  30. 30. AngioGuard XP
  31. 31. German Experience Eberhard Grube, Siegburg, GR 21 patients : –9 native coronary –4 carotid bifurcation –6 SVG
  32. 32. Cordis AngioGuard Clinical Data Vessel diam 3.3 + 0.35 mm (2.8-5.8) Stenosis 89% + 8.5% (70% - 95%) Procedural Success 100%
  33. 33. 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 )
  34. 34. 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
  35. 35. Embolic Particle Size 0 100000 200000 300000 400000 X-sectionalareaum^2 Largest SVG Carotid Native Coronary Maximum particle size recovered
  36. 36. Embolic Particle Size 0 10000 20000 30000 40000 X-sectionalareaum^2 Average SVG Carotid Native Coronary Average particle size recovered
  37. 37. Coronary SVG Carotid E. Grube Siegburg, GR
  38. 38. Material Recovered during PTCA
  39. 39. SAPPHIRE RCT + Registry – 30 Centers – 600 - 900 RCT – 400 Registry – 30 patients per center
  40. 40. SAPPHIRE – Asymptomatic >80% – Symptomatic >70% – RCT – High risk
  41. 41. 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)
  42. 42. 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
  43. 43. Sapphire Status of Patient Entry Total enrollment – 715 pts - Randomized – 312 pts Stent registry – 400 pts (closed) Surgical registry – 3
  44. 44. CREST - RCT Symptomatic Patients (NASCET) Enrolling 2500 – CEA vs. CS – 60 Centers – Enrollment - 40+ pts/center - 3 yrs
  45. 45. REGISTRIES – ARCHER 300 pts – EndoTex 300 pts – Shelter 630 pts – CARESS 2000 pts – Maverick 400 pts
  46. 46. 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.
  47. 47. 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
  48. 48. Conclusions Definite Role for Emboli Prevention Devices in Coronary and Peripheral Intervention Selective and Data Driven Most Compelling for Carotids, SVGs, MI, Renals
  49. 49. GPIIb/IIIa Inhibition and EmboliGPIIb/IIIa Inhibition and Emboli Prevention Devices?Prevention Devices?

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