should we be doing this? brains: carotid stenting keith g oldroyd department of cardiology western...
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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