Brains: Carotid Stenting

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Brains: Carotid Stenting

  1. 1. Should We Be Doing This? Brains: Carotid Stenting Keith G Oldroyd Department of Cardiology Western Infirmary
  2. 2. Carotid Intervention <ul><li>CEA results </li></ul><ul><ul><li>Symptomatic </li></ul></ul><ul><ul><li>Asymptomatic </li></ul></ul><ul><li>CAS + DP registries </li></ul><ul><li>CEA vs CAS in RCT’s </li></ul><ul><li>Setting up a CAS service </li></ul><ul><li>MY WORST COMPLICATION!! </li></ul>
  3. 9. NASCET/ECST/VA309 <ul><li>6092 patients with > 35K patients years </li></ul>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 <0.001 16.0 1095 > 70 (no sub-totals) 0.04 4.6 1549 50-69 0.60 3.2 1429 30-49 0.05 -2.2 1746 < 30 p Stroke RR(%) n % stenosis
  4. 10. NASCET
  5. 11. CEA rate/100,000 in Scotland by Health Board Stroke rate = 200 per 100K 80% ischaemic = 160 50% carotid stenosis = 80
  6. 12. CEA Rate / million >40 yrs old
  7. 13. MRC Asymptomatic Carotid Surgery Trial (ACST) <0.001 11.0 3.8 All patients <0.0001 9.56 3.20 80 - 90% DS <0.0001 9.49 2.06 60 - 80% DS <0.0001 9.67 2.18 Age 65-74 <0.0001 9.63 1.84 Age < 65 0.02 7.48 3.40 Women <0.0001 10.59 2.38 Men p Deferred CEA n=1560 Immediate CEA n=1560 5 year risk of stroke (%)
  8. 15. CAROTID STENTING
  9. 16. CAROTID STENTING
  10. 17. CAROTID STENTING
  11. 18. WALLSTENT 3.5% 12% 1 year 3.5% 10.2% 30 days CEA (n=113) Stenting (n=108) Death/ipsilateral stroke
  12. 19. The GuardWire  Protection System
  13. 20. CAFE-USA Registry Percusurge in Carotid Stenting <ul><li>212 patients </li></ul><ul><li>99% procedural success </li></ul><ul><li>8% required “staged” protection </li></ul><ul><li>Visual embolic material in every case </li></ul><ul><li>Mean 12 min of balloon occlusion </li></ul><ul><li>30 day - mortality: 1.4% stroke: 2.4% </li></ul>
  14. 21. CAFE-USA Registry TCD Sub-study 0.002 68 164 Total 0.002 5 27 Post dilatation 0.004 17 75 Stent deployment 0.001 12 32 Predilatation p Protection Control
  15. 22. Carotid Wallstent™ (BSCI) <ul><li>S/E monorail closed cell </li></ul><ul><li>braided chromium cobalt </li></ul><ul><li>Diameter - 6, 8, 10 mm </li></ul><ul><li>Length - 30, 40, 50 mm </li></ul><ul><li>5F - 6, 8 mm </li></ul><ul><li>6F - 10 mm </li></ul>
  16. 23. FilterWire EZ™ (BSCI) <ul><li>One size fits 3.5 to 5.5mm vessel diameters </li></ul><ul><li>3.2F Profile </li></ul><ul><li>0.014’’ Monorail™ exchange system </li></ul><ul><li>Preloaded wire </li></ul>110 micron Polyurethane membrane <ul><li>Suspended Radiopaque Nitinol loop </li></ul><ul><li>Adapts to vessel sizes and diameter changes </li></ul>
  17. 24. Guidant Acculink/Accunet S/E open cell nitinol with longitudinal links
  18. 25. Protégé GPS (eV3) S/E open cell nitinol carotid stent
  19. 26. <ul><ul><li>Heparin coated nitinol braid filter </li></ul></ul><ul><ul><li>Multiple sizes from 3-7mm to match vessel size </li></ul></ul><ul><ul><li>Use any 014” guidewire for initial cross </li></ul></ul><ul><ul><li>Single Dual-Ended Low-Profile Catheter </li></ul></ul><ul><ul><li>Pre-loaded Filter </li></ul></ul><ul><ul><li>6Fr compatible </li></ul></ul><ul><ul><li>Rapid exchange </li></ul></ul><ul><ul><li>Snapwire converts to 190 cm RX length </li></ul></ul>SpideRX™
  20. 27. NexStent™ (EndoTex/BSCI) <ul><li>30mm S/E closed cell rolled nitinol sheet </li></ul><ul><li>5F system that can deliver a 9mm stent </li></ul><ul><li>Straight and tapered vessel segments of 4-9mm </li></ul><ul><li>High crush resistance </li></ul><ul><li>Moderate chronic outward radial force </li></ul>
  21. 28. NexStent™ <ul><li>Integrated deployment handle allows accurate stent placement by providing a mechanical advantage during retraction of delivery sheath </li></ul><ul><li>Distal flare anchors stent during deployment with minimal foreshortening of < 10% at 9mm </li></ul>
  22. 30. USA Carotid Stenting Studies 30-Day Composite Endpoint Patients (%) 5.2% SAPPHIRE ARCHeR2 N=278 SECuRITY N=305 BEACH N=747 7.8% 5.8% 7.2% CABERNET N=454 3.8% 5.8% MAVErIC N=52
  23. 31. CAVATAS - 1 0.001 6.7% 1.2% Major haematoma 0.001 8.7% 0 Cranial neuropathy NS 9.9% 10% Death/any stroke NS 5.9% 6.4% Death/major stroke p CEA Angioplasty
  24. 32. S tenting and A ngioplasty with P rotection in P atients at H igh R isk for E ndarterectomy SAPPHIRE <ul><li>RCT using distal protection in stent group </li></ul><ul><li>29 US centres </li></ul><ul><li>Asymptomatic ≥ 80% </li></ul><ul><li>Symptomatic ≥ 50% </li></ul><ul><li>At least 1 high risk feature (defined by surgeons) </li></ul><ul><ul><li>Age > 80 </li></ul></ul><ul><ul><li>CHF </li></ul></ul><ul><ul><li>Severe COPD </li></ul></ul><ul><ul><li>Previous CEA </li></ul></ul><ul><ul><li>Previous radiation therapy or neck surgery </li></ul></ul><ul><ul><li>Proximal or distal lesions </li></ul></ul><ul><ul><li>(contralateral occlusion) </li></ul></ul>
  25. 33. SAPPHIRE S tenting and A ngioplasty with P rotection in P atients at H igh R isk for E ndarterectomy <ul><li>Cases assessed by interventionist, surgeon and neurologist </li></ul><ul><ul><li>Consensus: randomised </li></ul></ul><ul><ul><li>Rejected for CEA: intervention registry </li></ul></ul><ul><ul><li>Rejected for CAS: surgical registry </li></ul></ul><ul><li>Enrollment stopped prematurely in June 2002 </li></ul><ul><ul><li>Stent registry: 409 </li></ul></ul><ul><ul><li>Surgical registry: 7 </li></ul></ul><ul><ul><li>Randomised: 310 </li></ul></ul>
  26. 34. S/E open cell nitinol Smart/Precise TM stent and Angioguard XP TM distal protection system
  27. 35. SAPPHIRE 30 day complications <0.01 5.3% 0.0% Cranial nerve injury 0.56 10.6% 8.3% Major bleeding 0.50 2.0% 3.8% TIA p CEA (n=151) Stenting (n=159)
  28. 36. SAPPHIRE 12 month outcomes NEJM 2004; 351: 493-501 0.048 19.9% 11.9% Death/stroke/MI 0.04 7.9% 2.5% MI NS 7.3% 5.7% Stroke 32/409 (15.8%) Stent registry 4.0% 0.6% TLR NS 12.6 6.9% Death P CEA (n=151) Stenting (n=159)
  29. 37. ELOCAS Registry <ul><li>M Bosiers, Dendermonde, Belgium </li></ul><ul><li>P Peeters, Imelda Hospital, Belgium </li></ul><ul><li>H Sievert, Frankfurt CC, Germany </li></ul><ul><li>A Cremonesi, Ravenna, Italy </li></ul><ul><li>Feb 93 to Dec 04 </li></ul><ul><li>2172 patients </li></ul>J Cardiovasc Surgery 2005; 46: 241-247 1.2% Procedural Death/major stroke 15.5% (n=138) 5 years 10.1% (n=476) 3 years 4.1% (n=1356) 1 year
  30. 38. ELOCAS Registry 4.1% Distal occlusion (n=2) 33.4% S/E open cell nitinol (n=8) 4.7% S/E closed cell nitinol (n=3) 61.9% S/E cobalt chromium (n=1) 1.6% Balloon expandable (n=11) 95.6% Stenting 70.3% Direct 85.9% Embolic protection 10.5% Proximal occlusion (n=2) 85.3% Distal filters (n=9) 99.7% Procedural success
  31. 39. Starting a CAS Service <ul><li>Team approach </li></ul><ul><ul><li>Vascular surgeons </li></ul></ul><ul><ul><li>Stroke physician/neurologist </li></ul></ul><ul><ul><li>Interventional radiologist/cardiologist </li></ul></ul><ul><li>High quality readily available imaging </li></ul><ul><ul><li>Doppler U/S and TCD </li></ul></ul><ul><ul><li>MRA </li></ul></ul><ul><li>HDU/CCU care post procedure </li></ul><ul><ul><li>Meticulous control of BP </li></ul></ul>
  32. 42. My Worst Complication <ul><li>75 year old male </li></ul><ul><li>3 minor left sided anterior circulation strokes in previous 5 months and hospitalised since first event </li></ul><ul><ul><li>CHD – previous MI </li></ul></ul><ul><ul><li>Chronic Cl.diff infection </li></ul></ul><ul><ul><li>Chronic alcohol abuse </li></ul></ul><ul><li>CT brain – diffuse ischaemic change/moderate atrophy </li></ul><ul><li>Doppler U/S </li></ul><ul><ul><li>> 70% RICA stenosis; 50-69% LICA </li></ul></ul><ul><li>MRA – confirmed severe RICA stenosis with ulceration </li></ul><ul><li>Turned down for CEA </li></ul><ul><li>Referred for CAS </li></ul>
  33. 43. JB – RCCA access
  34. 44. JB – RICA stenosis
  35. 45. JB – Stent deployment (Protégé)
  36. 46. JB – post Protégé
  37. 47. JB – Stent deployment (Wallstent)
  38. 48. JB – Final result
  39. 49. JB – Post CAS <ul><li>Uneventful recovery up to 5 days post CAS </li></ul><ul><li>Sudden deterioration with hypertension and focal seizures </li></ul><ul><li>Deteriorating conscious level </li></ul><ul><li>Doppler U/S – widely patent stents but very high flow velocities in ICA and MCA </li></ul><ul><li>CT – diffuse basal SAH </li></ul><ul><li>Died 36 hours post CT </li></ul><ul><li>Diagnosis – ? </li></ul>
  40. 53. Cerebral Hyperperfusion Syndrome <ul><li>Failure of cerebral autoregulation post revascularisation </li></ul><ul><ul><li>2.7% of CEA’s </li></ul></ul><ul><li>Presenting symptoms </li></ul><ul><ul><li>Self-limiting headache to fatal ICH (0.3-0.7%) </li></ul></ul><ul><li>6 previous reports of ICH </li></ul><ul><li>1 previous report of SAH (J Neurol 1997; 244: 101-4) </li></ul><ul><li>Differential diagnosis </li></ul><ul><ul><li>Spasm </li></ul></ul><ul><ul><li>Dissection </li></ul></ul><ul><ul><ul><li>Angio; no dissection in previously reported case </li></ul></ul></ul><ul><ul><li>SAH from pre-existing aneurysm </li></ul></ul><ul><ul><ul><li>Not detected on pre-procedure MRA </li></ul></ul></ul>
  41. 54. Take Home Messages via Gary Roubin <ul><li>Get trained </li></ul><ul><ul><li>It’s not as easy as it looks </li></ul></ul><ul><ul><li>Learning curve ~ 80 cases </li></ul></ul><ul><li>Start with easy cases </li></ul><ul><ul><li>Unilateral stenosis </li></ul></ul><ul><ul><li>No major co-morbidity </li></ul></ul><ul><li>Ensure high standard of post procedure care </li></ul><ul><ul><li>CCU/HDU </li></ul></ul><ul><ul><li>Transient hypotension/hypertension </li></ul></ul>

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