Carotid Stenting: St. Mary’s Hospital 2002 A clinical case

Carotid stent team Jeremy Chattaway Nick Cheshire Rodney Foale/Jamil Mayet/Iqbal Malik Martin Clark

Petrous A2 A1 Ant Com Art Cavernous M2 upper M2 lower M1 Level of dura

Background Then: –“PTCA is barbaric and without evidence as a treatment for CAD” Now: –Coronary stenting accepted as standard therapy for CAD Could the same happen for carotid stenting?

Pre-requisites for success Prove surgery is better than tablets Prove percutaneous approach is almost as good as surgery Add stents/adjunctive therapy to make percutaneous equivalent to surgery

Case RH-1 Age63 male PMHSevere AR LAD stenosis Poor LV Risk Factors HTLipids DMPVD Ex- Smoking Cerebrovascular Hx “TIA” 15 yrs ago Asymptomatic now Cardiac Hx increasing dyspnoea no angina

Case RH-2 Investigations ECGLat ST sag EchoLV7/8cm Mod severe AR Creatinine152 K 3.8 Hb15.0 INR 1.2 CVD Investigations Duplex MRA Arch angio

Case RH-3 Medication –WarfarinDigoxin125mic –Bisoprolol2.5Amlodipine5 –Enalapril15 bdPravastatin40 –Imdur30Clopidogrel75 –Frusemide40

Case RH- non-selective cerebral

Plan of action-RH Aim –Reduce CVA risk prior to AVR and grafts Rationale –Discussed twice at neurovascular meeting Risks of CEA high-not a suitable candidate –Discussed twice at Joint cardiology/surgery meeting Needs AVR otherwise cardiac lifespan limited –Discussed by CAS team

Evidence based medicine Risk of AVR/CABG –>3000 pts CVA risk –Stenosis <50% 1.6% –Stenosis 50-99% 3.8% –Occlusion 6.5% –Occ+stenosis 25% CEA plus CABG/AVR –CEA first Cardiac risk very high –Cardiac/CEA togather Shorter stay 10 days Higher CVA/death risk? 9.5% vs 5.7% 30d risk –Cardiac first Asymptomatic >70% stenosis 1%/yr CVA

Final Plan- RH Do Both Carotids with stents? Do one carotid only? –Risk of hyperperfusion injury –Improve hemodynamic reserve –Try second one later

Technique guidewire 5F VTK catheter Sheath introducer 7F shuttle sheath

R

RH RICA day 3

LICA to do

Hall LICA Procedue

Hall LICA

TRAP removal

RH Rx with aspirin + clopidogrel for 4 weeks Returned for AVR 4 weeks later –LIMA graft to LAD –Bileaflet AVR –Remarkable recovery Plan for home day 7 –Returned to ITU day 7 chest infection –Home day 12

Pre-requisites for success Prove surgery is better than tablets Prove percutaneous approach is almost as good as surgery Add stents/adjunctive therapy to make percutaneous equivalent to surgery

Background Stroke in the population –12% of all deaths in UK are due to CVA –1 million CVA in Europe/year Carotid stenosis is major cause of CVA –Recent symptoms-28% 2-year risk CVA –Incidence of carotid stenosis >80% % of population

Why have a stent program? CEA tricky –Restenosis –Not C2-C7 –Hostile neck RT Surgery Scars –High risk Medical Morbidity Neuro Morbidity RLN palsy contralat CAS –Minimally Invasive –No scar –No GA Easy –Equivalent –Treatment of occlusion post CEA

Eastcott/ Debakey 1953 CEA NASCET (659) –>70% stenosis –2-yr fu CVA 9% vs 26% on medical Rx ECST (3024) –>60% stenosis –3-yr fu CVA 14.9% vs 26.5% on medical Rx ACAS –>60% stenosis –5-yr fu CVA 5.1% vs 11% on medical Rx Prove surgery is better than tablets

Prove percutaneous approach is almost as good as surgery Carotid and vertebral artery angioplasty study –Randomisation –560 pts –504 PTA vs surgery –86% stenosis Only 55 stents used –One CVA at time of stent.

CAVATAS PTASurgeryp 30d death/CVA 10%9.9%p=ns CN palsy0%9%p< Haematoma1%7%P= MI0%0.8%ns Re-stenosis17%5%P<0.0001

CAVATAS QOL same Cost in lab same Total cost greater for surgery as ITU stay –£946 Stent –cost of PTA from £1086 to £1864

Carotid Stenting At first… –5 out of 7 had CVA with stent (RCT 1998) –219 patients- death<1 year/CVA 12.1% stent vs. 3.6% CEA (p = 0.022). (RCT 2001) Randomised Trials

Stent vs surgery ICSS SPACE- Stent-protected Percutanous Angioplasty-Carotid Endarterectomy trial EVA-3S- Endarterectomy versus angioplasty in patients with severe symptomatic carotid stenosis study CREST- Carotid Revascularisation Endarterectomy vs stenting trial SAPPHIRE -Stenting and Angioplasty with protection in Patients with High Risk for Endarterectomy

Trial Update Randomized Studies CAVATAS completed (only 30% stent use) CREST (NIH/NHLBI) (U.S., 2500 pts., low risk) SAPPHIRE (U.S., pts., high risk population CAVATAS 2 (society initiated) (worldwide 2000 pts.) SPACE (society initiated) (Germany, 1900 pts.) High Risk Registries including 2400 patients ARCHeR Maverick Beach Mednova Cabernet

World wide CAS

K. Mathias, H. Jaeger, ISET, Miami 2001

Asymptomatic DataTreatment30d CVA/death ACASMedical CEA 0.4% 3% MathiasCAS c DPD1.6% WholeyNo DPD DPD 3.97% 1.75% MetanalaCEA3.4% SAPPHIRE 2002 CAS c DPD CEA 6.7% 11.2%

DataTreatment30d CVA/death NASCETMedical CEA 3% 6.5% ECSTMedical CEA 3% 7% WholeyNo DPD DPD 6.7% 2.82% CAVATASCEA CAS 9.9% (6.4) 9.9% (4.0) SAPPHIRE 2002 CAS c DPD CEA 4.2% 15.4% Symptomatic

SMH 2002-a clinical case Patients with high risk A research program-ICSS Patient choice

Flanders study

ICSS entry criteria Inclusion >40 >70% stenosis Extracranial IC or bifurcation lesion Excusion CVA with no recovery Can’t stent –Tortuous –Thrombus –Common carotid stenosis –Pseudo-occlusion Can’t op

ICSS outcome events Death/ any CVA TIA MI<30d CN palsy<30d Hematoma (tx/op/long stay) >70% stenosis at FU Reintervention QOL Costs

Conclusion The carotid is 25 years behind the coronary It is catching up fast. Different vessel and vascular bed (cf diabetes) The multidisciplinary team SMH at the lead

Distal protection devices DevicePore sizeDeliveryRetrievalPrepn Rubicon wire 100  Max 2F (0.028)nil Angioguard XP (OTW) 100  Max 8mm F (2 wires) OTW 5.1F On table Cordis Epi-filter EX Or EZ (Mono)  mm EX 3.9F EZ 3.0F Mono Sheath On table Boston Spider (OTW)  3-7mm 2.9FMono sheath On table EV3 Interceptor wire 100  <6.5mm 2.9FMedtronic TRAP (OTW) 100  <7mm 3.5F4.5FLoading EV3

Distal Protection devices DevicePore size DeliveryRetrievalPrepn Arteria (Parodi) -10FnilReverse flow Prox occ. MOMA (OTW) -11F FNot flow reversal Prox occ. Mednova Percusurge (OTW/mono) --Distal occ.

Angioguard (Cordis) Percusurge

ARTERIA (PARODI)