Should We Be Doing This? Brains: Carotid Stenting Keith G Oldroyd Department of Cardiology Western 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/VA patients with > 35K patients years % stenosisnStroke RR(%)p < > 70 (no sub-totals) <0.001 Sub-totals – trend towards benefit at 2 years, gone by 5 years Amaurosis fugax only – no benefit Absolute benefit increases with age Lancet Jan 11, 2003

NASCET

CEA rate/100,000 in Scotland by Health Board Stroke rate = 200 per 100K 80% ischaemic = % carotid stenosis =80

CEA Rate / million >40 yrs old

MRC Asymptomatic Carotid Surgery Trial (ACST) 5 year risk of stroke (%) Immediate CEA n=1560 Deferred CEA n=1560 p All patients <0.001 Men < Women Age < < Age < % DS < % DS <0.0001

CAROTID STENTING

WALLSTENT Death/ipsilateral stroke Stenting (n=108) CEA (n=113) 30 days10.2%3.5% 1 year12%3.5%

The GuardWire  Protection System

CAFE-USA Registry Percusurge 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 Registry TCD Sub-study ControlProtectionp Predilatation Stent deployment Post dilatation Total

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/Accunet S/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 Studies 30-Day Composite Endpoint Patients (%) 5.2% SAPPHIREARCHeR2N=278SECuRITYN=305BEACHN= % 5.8% 7.2% CABERNETN= % 5.8% MAVErICN=52

CAVATAS - 1 AngioplastyCEAp Death/major stroke 6.4%5.9%NS Death/any stroke 10%9.9%NS Cranial neuropathy 08.7%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)

SAPPHIRE Stenting 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/Precise TM stent and Angioguard XP TM distal protection system

SAPPHIRE 30 day complications Stenting (n=159) CEA (n=151) p TIA3.8%2.0%0.50 Major bleeding8.3%10.6%0.56 Cranial nerve injury0.0%5.3%<0.01

SAPPHIRE 12 month outcomes Stenting (n=159) CEA (n=151)P Death6.9%12.6NS Stroke5.7%7.3%NS MI2.5%7.9%0.04 Death/stroke/MI11.9%19.9%0.048 TLR0.6%4.0% Stent registry32/409 (15.8%) NEJM 2004; 351:

ELOCAS Registry M Bosiers, Dendermonde, Belgium P Peeters, Imelda Hospital, Belgium H Sievert, Frankfurt CC, Germany A Cremonesi, Ravenna, Italy Feb 93 to Dec patients Death/major stroke Procedural1.2% 1 year4.1% (n=1356) 3 years10.1% (n=476) 5 years15.5% (n=138) J Cardiovasc Surgery 2005; 46:

ELOCAS Registry Procedural success99.7% Stenting95.6% Direct70.3% 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 protection85.9% 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 ( %) 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 Messages via 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