Role of embolic protection device in coronary and carotid intervention
Embolic protection devices
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Transcript of Embolic protection devices
Embolic Protection DevicesEmbolic Protection Devices
Jay S. Yadav M.D.
Director, Vascular
InterventionDepartment of Cardiovascular
MedicineThe Cleveland
Clinic Foundation
Everyone Embolizes
ejt 048–114Pettelot, et al. Circ 97:1522, 1998Pettelot, et al. Circ 97:1522, 1998
Embolization
Common and under recognized CABG 6% stroke CEA 3-10% SVG PTCA4-18% 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
Acute Coronary Syndromes
ejt 029–144
The “Hot” VesselThe “Hot” Vessel
MicrovascularMicrovascularObstructionObstruction
1000x1000x5x5x
BasalBasal PeakPeak00
55
1010
1515
2020
2525Heparin Alone, N=98Abciximab, 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
Transcranial Doppler (TCD)
MIDDLECEREBRALARTERYVELOCITYCM/SEC
EMBOLI
BALLOON INFLATED DEFLATED
Ex-Vivo Carotid Plaque Embolization Model - Ohki
Embolic Particles were generated from each plaque
Ex-Vivo Carotid Plaque Embolization ModelOhki T et al. J Vasc Surg 1998; 27:463-71
YADAV
Ex-Vivo Carotid Plaque Embolization Model
Ohki T et al. J Vasc Surg 1998; 27:463-71Number of emboli and lesion characteristics
Echolucent0
25
50
75
100
125
Echogenic
Num
ber o
f par
ticle
s
p=0.012
Num
ber o
f par
ticle
s
0
25
50
75
100
125
50 60 70 80 90 100
% Stenosis
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
Rapp et al J Vasc Surgery 2000;32:68-76
Most particles released during PTA/Stenting
<200 u 200-500 uDay 1 & 3 nl neuronal ischDay 7 neuronal ischemia
Anti-Embolization Devices
Occlusive:– Distal Flow Arrest
» Theron - Balloon Occlusion Catheter» PercuSurge - Balloon Occlusion Guidewire
– Proximal Flow Arrest» Arteria- Balloon Occlusion Guide
Catheter
Anti-Embolization Devices
Non-Occlusive: – Supported Filters:
» AngioGuard - Guidewire Filter» MedNova - Guidewire Filter» Trap - Nitinol Filter
– Unsupported Filters:» EPI- Guidewire Filter» Etrap - Guidewire Filter
PercuSurge Guard Wire
AngioGuard XP
ArteriA PAEC
Arteria Proximal Flow Arrest - Parodi
External to internal carotid flow during common carotidOcclusion:
Baseline External Occlusion: 1 pt ICA to ECA flow: 10 pts / 7.3 %
ECA to ICA flow: 62 pts / 84.9 %
Results:
1st Generation 3.9F sheath - 0.014” Wire
Capture EfficiencyParticle Retention Trackability & FlexibilityOne to One TorquabilityRadiopacityWithdraws into 0.035” angioplasty balloon
Universal ApplicationUninterrupted blood flow ( 80µm pores )
EPI
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
Microvena Trap
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 PSTIMI 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
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
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
Percusurge Renal Stent
Percusurge Renal Stent
Reduced Delivery Profile
New 4 mm @ 3.2 F profile
Current 4 mm @ 4.6 F profile
Crossing Profiles4 mm 3.2 F5 mm 3.3 F6 mm 3.5 F7 mm 3.7 F8 mm 3.9 F
Lubricious coating on delivery sheath
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 (Area) 0.10 mm2 + 0.5 mm2 (0.015-20) Embolic Burden per pt:
37 mm2 + 36 mm2 (0.6 mm2 - 110 mm2)
Filter Surface Coverage
31 3236
05
10152025303540
% Filter Surface Coverage
SVG Carotid Native Coronary
Average % of filter surface covered with embolic particles
Range 0-80Range 0-60Range 5-50
Embolic Particle Size
0
100000
200000
300000
400000
X-se
ctio
nal a
rea
um^2
Largest
SVG Carotid Native Coronary
Maximum particle size recovered
Embolic Particle Size
0
10000
20000
30000
40000
X-se
ctio
nal a
rea
um^2
Average
SVG Carotid Native Coronary
Average particle size recovered
Coronary SVG
Carotid
E. GrubeSiegburg, 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 MI (>24hrs <4weeks) Unstable angina (CCS class III/IV) Synchronous severe CAD and carotid disease Severe pulmonary disease (FEV<1.0)
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
SapphireStatus of Patient Entry
Total enrollment– 715 pts -
Randomized– 312 pts
Stent registry– 400 pts (closed)
Surgical registry– 3
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: 4-8 mm Filter pore size
120 microns Designed to maintain
perfusion
Caution: Investigational device. Limited by Federal (U.S.) Law to investigational use.
CAROTID TrialsTrials 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
Conclusions
Definite Role for Emboli Prevention Devices in Coronary and Peripheral Intervention
Selective and Data Driven Most Compelling for Carotids, SVGs, MI,
Renals
GPIIb/IIIa Inhibition and Emboli GPIIb/IIIa Inhibition and Emboli Prevention Devices?Prevention Devices?