Should We Be Doing This?Brains: Carotid Stenting

Keith G Oldroyd

Department of CardiologyWestern Infirmary

Carotid Intervention

• CEA results– Symptomatic– Asymptomatic

• CAS + DP registries

• CEA vs CAS in RCT’s

• Setting up a CAS service

• MY WORST COMPLICATION!!

NASCET/ECST/VA309

• 6092 patients with > 35K patients years

% stenosis n Stroke RR(%) p

< 30 1746 -2.2 0.05

30-49 1429 3.2 0.60

50-69 1549 4.6 0.04

> 70 (no sub-totals) 1095 16.0 <0.001

Sub-totals – trend towards benefit at 2 years, gone by 5 yearsAmaurosis fugax only – no benefitAbsolute benefit increases with age Lancet Jan 11, 2003

NASCET

CEA rate/100,000 in Scotland by Health Board

0.0

5.0

10.0

15.0

20.0

25.0

1997

1998

1999

2000

2001

2002

2003

2004

p

Argyll and Clyde

Ayrshire and Arran

Borders

Dumfries and Galloway

Fife

Forth Valley

Grampian

Greater Glasgow

Highland

Lanarkshire

Lothian

Orkney Islands

Shetland Islands

Tayside

Western Isles

Stroke rate = 200 per 100K80% ischaemic = 16050% carotid stenosis = 80

CEA Rate / million >40 yrs old

0100200

300400

500600

700800900

1000

US 1995 Canada 1995 Scotland 2004

MRC Asymptomatic Carotid Surgery Trial (ACST)

5 year risk of stroke (%)

Immediate CEA

n=1560

Deferred CEA

n=1560

p

All patients 3.8 11.0 <0.001

Men 2.38 10.59 <0.0001

Women 3.40 7.48 0.02

Age < 65 1.84 9.63 <0.0001

Age 65-74 2.18 9.67 <0.0001

60 - 80% DS 2.06 9.49 <0.0001

80 - 90% DS 3.20 9.56 <0.0001

CAROTID STENTING

CAROTID STENTING

CAROTID STENTING

WALLSTENT

Death/ipsilateral stroke

Stenting

(n=108)

CEA

(n=113)

30 days 10.2% 3.5%

1 year 12% 3.5%

The GuardWire Protection System

CAFE-USA RegistryPercusurge in Carotid Stenting

• 212 patients

• 99% procedural success

• 8% required “staged” protection

• Visual embolic material in every case

• Mean 12 min of balloon occlusion

• 30 day - mortality: 1.4%stroke: 2.4%

CAFE-USA RegistryTCD Sub-study

Control Protection p

Predilatation 32 12 0.001

Stent deployment 75 17 0.004

Post dilatation 27 5 0.002

Total 164 68 0.002

Carotid Wallstent™ (BSCI)• S/E monorail closed cell• braided chromium cobalt• Diameter - 6, 8, 10 mm• Length - 30, 40, 50 mm• 5F - 6, 8 mm• 6F - 10 mm

FilterWire EZ™ (BSCI)

• One size fits 3.5 to 5.5mm vessel diameters

• 3.2F Profile

• 0.014’’ Monorail™ exchange system

• Preloaded wire

110 micron Polyurethane membrane

• Suspended Radiopaque Nitinol loop• Adapts to vessel sizes and diameter changes

Guidant Acculink/AccunetS/E open cell nitinol with longitudinal links

Protégé GPS (eV3)S/E open cell nitinol carotid stent

– Heparin coated nitinol braid filter– Multiple sizes from 3-7mm to match vessel size– Use any 014” guidewire for initial cross– Single Dual-Ended Low-Profile Catheter– Pre-loaded Filter– 6Fr compatible– Rapid exchange– Snapwire converts to 190 cm RX length

SpideRX™

NexStent™ (EndoTex/BSCI)

• 30mm S/E closed cell rolled nitinol sheet• 5F system that can deliver a 9mm stent• Straight and tapered vessel segments of 4-9mm• High crush resistance• Moderate chronic outward radial force

NexStent™

• Integrated deployment handle allows accurate stent placement by providing a mechanical advantage during retraction of delivery sheath

• Distal flare anchors stent during deployment with minimal foreshortening of < 10% at 9mm

USA Carotid Stenting Studies30-Day Composite Endpoint

0

2

4

6

8

10

Pati

ents

(%

)Pati

ents

(%

)

5.2%5.2%

SAPPHIRESAPPHIREARCHeR2ARCHeR2N=278N=278

SECuRITYSECuRITYN=305N=305

BEACHBEACHN=747N=747

7.8%7.8%

5.8%5.8%7.2%7.2%

CABERNETCABERNETN=454N=454

3.8%3.8%

5.8%5.8%

MAVErICMAVErIC N=52N=52

CAVATAS - 1

Angioplasty CEA p

Death/major stroke

6.4% 5.9% NS

Death/any

stroke

10% 9.9% NS

Cranial neuropathy

0 8.7% 0.001

Major haematoma

1.2% 6.7% 0.001

Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy

SAPPHIRE

• RCT using distal protection in stent group• 29 US centres• Asymptomatic ≥ 80%• Symptomatic ≥ 50%• At least 1 high risk feature (defined by surgeons)

– Age > 80– CHF– Severe COPD– Previous CEA– Previous radiation therapy or neck surgery– Proximal or distal lesions– (contralateral occlusion)

SAPPHIREStenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy

• Cases assessed by interventionist, surgeon and neurologist– Consensus: randomised– Rejected for CEA: intervention registry– Rejected for CAS: surgical registry

• Enrollment stopped prematurely in June 2002– Stent registry: 409– Surgical registry: 7– Randomised: 310

S/E open cell nitinol Smart/PreciseTM stent and Angioguard XPTM distal protection system

SAPPHIRE30 day complications

Stenting

(n=159)

CEA

(n=151)

p

TIA 3.8% 2.0% 0.50

Major bleeding 8.3% 10.6% 0.56

Cranial nerve injury 0.0% 5.3% <0.01

SAPPHIRE12 month outcomes

Stenting

(n=159)

CEA

(n=151) P

Death 6.9% 12.6 NS

Stroke 5.7% 7.3% NS

MI 2.5% 7.9% 0.04

Death/stroke/MI 11.9% 19.9% 0.048

TLR 0.6% 4.0%

Stent registry 32/409 (15.8%)

NEJM 2004; 351: 493-501

ELOCAS Registry• M Bosiers, Dendermonde, Belgium• P Peeters, Imelda Hospital, Belgium• H Sievert, Frankfurt CC, Germany• A Cremonesi, Ravenna, Italy• Feb 93 to Dec 04• 2172 patients

Death/major stroke

Procedural 1.2%

1 year 4.1% (n=1356)

3 years 10.1% (n=476)

5 years 15.5% (n=138)

J Cardiovasc Surgery 2005; 46: 241-247

ELOCAS Registry

Procedural success 99.7%

Stenting 95.6%

Direct 70.3%

Balloon expandable (n=11) 1.6%

S/E cobalt chromium (n=1) 61.9%

S/E open cell nitinol (n=8) 33.4%

S/E closed cell nitinol (n=3) 4.7%

Embolic protection 85.9%

Distal occlusion (n=2) 4.1%

Distal filters (n=9) 85.3%

Proximal occlusion (n=2) 10.5%

Starting a CAS Service

• Team approach– Vascular surgeons– Stroke physician/neurologist– Interventional radiologist/cardiologist

• High quality readily available imaging– Doppler U/S and TCD– MRA

• HDU/CCU care post procedure– Meticulous control of BP

My Worst Complication

• 75 year old male• 3 minor left sided anterior circulation strokes in previous

5 months and hospitalised since first event– CHD – previous MI– Chronic Cl.diff infection– Chronic alcohol abuse

• CT brain – diffuse ischaemic change/moderate atrophy• Doppler U/S

– > 70% RICA stenosis; 50-69% LICA

• MRA – confirmed severe RICA stenosis with ulceration• Turned down for CEA• Referred for CAS

JB – RCCA access

JB – RICA stenosis

JB – Stent deployment (Protégé)

JB – post Protégé

JB – Stent deployment (Wallstent)

JB – Final result

JB – Post CAS

• Uneventful recovery up to 5 days post CAS• Sudden deterioration with hypertension and

focal seizures• Deteriorating conscious level• Doppler U/S – widely patent stents but very high

flow velocities in ICA and MCA• CT – diffuse basal SAH• Died 36 hours post CT• Diagnosis – ?

Cerebral Hyperperfusion Syndrome

• Failure of cerebral autoregulation post revascularisation– 2.7% of CEA’s

• Presenting symptoms– Self-limiting headache to fatal ICH (0.3-0.7%)

• 6 previous reports of ICH • 1 previous report of SAH (J Neurol 1997; 244: 101-4)

• Differential diagnosis– Spasm– Dissection

• Angio; no dissection in previously reported case– SAH from pre-existing aneurysm

• Not detected on pre-procedure MRA

Take Home Messagesvia Gary Roubin

• Get trained– It’s not as easy as it looks– Learning curve ~ 80 cases

• Start with easy cases– Unilateral stenosis– No major co-morbidity

• Ensure high standard of post procedure care– CCU/HDU– Transient hypotension/hypertension