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?