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gpday3sept09interventions.ppt

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  • Atheroma and its complications are the most common cause of TIA and infarction. Small vessel disease within the brain about 25% of the total, and embolism from the heart another 20%. The rest are caused by rarer arterial disorders (eg arterial dissection) and blood disorders (eg sickle cell disease).
  • Beneficial effect of carotid endarterectomy in symptomatic patients with high-grade carotid stenosis. North American Symptomatic Carotid Endarterectomy Trial Collaborators. N Engl J Med 1991 Aug 15;325(7):445-453
  • 3 year death/CVA or CVA ipsilateral –no difference
    Restenosis did not lead to changed outcome, but short FU.
  • Lechat n=60
  • I like balance

Transcript

  • 1. NWLCSN GP DIPLOMA COURSE 2009
  • 2. Agenda
  • 3. Speakers • Nick Peters • Prapa Kanagaratnam • Richard Perry • Diane Ames • Harri Jenkins • Iqbal Malik
  • 4. Interventions for Stroke prevention When, who, what? Iqbal Malik Consultant Interventional Cardiologist 2009
  • 5. Topics to cover • Treatment of carotid stenosis • Treatment of PFO • LAA closure • Not – Medical management – AF management
  • 6. Ischaemic stroke • Atherothromboembolism 50% • Small vessel disease 25% • Cardioembolism 20% • Other rarities 5%
  • 7. Carotid stenosis is major cause of CVA – Recent symptoms • 28% 2-year risk CVA – carotid stenosis >80% • 0.3-2.4% of population
  • 8. Who to treat? • Symptomatic carotid stenosis • Asymptomatic carotid stenosis • Pre CABG
  • 9. 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 BETTER THAN surgery
  • 10. • Eastcott/ Debakey 1953 CEA Symptomatic • 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 Asymptomatic • ACAS – >60% stenosis – 5-yr fu CVA 5.1% vs 11% on medical Rx • ASCT – >80% stenosis – 5 year fu CVA Prove surgery is better than tablets
  • 11. How severe a stenosis? • Asymptomatic – >80% • Symptomatic – >70% on angio – Possibly lower (US 50%)
  • 12. Quantify the risk of the procedure • Asymptomatic stenosis – 60% stenosis • Medical Rx CVA/death 2.2% 1 year • CEA CVA/death 3% 30 day – >80% • Medical Rx CVA/death 5.5% 1 year • CEA CVA/death 4.6% 30 day
  • 13. Choose your surgeon • Stroke/death <3% in asymptomatic patients • Does it regularly • CEA is a great operation • BUT…………..
  • 14. recurrent hemisspheric TIA; high grade ICA stenosis pre post Carotid Wallstent™ 9.0/30 mmO.L. 1148/99
  • 15. Prove percutaneous approach is almost as good as surgery • CAVATAS – Randomisation 1992-1997 – 560 pts – 504 PTA vs surgery – 86% stenosis • Only 55 stents used – One CVA at time of stent.
  • 16. CAVATAS PTA Surgery p 30d death/CVA 10% 9.9% p=ns CN palsy 0% 9% p<0.0001 Haematoma 1% 7% P=0.0015 MI 0% 0.8% ns Re-stenosis 17% 5% P<0.0001
  • 17. World wide CAS
  • 18. Angioguard (Cordis) Percusurge
  • 19. 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
  • 20. The real life data • CEA (VSSGBI) – Mortality 1.3% – LOS 3.9d – Death/Stroke risk 3% • CAS (World registry) – Mortality 1% – LOS 1.8d – Death/Stroke risk 3% – Death/stroke risk 1.8-2.8% All patients High risk patients
  • 21. Sapphire Trial Asymptomatic >80% Symptomatic >50% n=747 Surgeon said no n=409 Randomised n=307 Stenter said no n=7 Stent registry SAPPHIRE CEA registry Stent n=156 CEA n=151
  • 22. Results at 30 days 0.0 2.0 4.0 6.0 8.0 10.0 12.0 14.0 Total death/stroke Stent CEA Registry MAE=death/MI/CVA
  • 23. Sapphire trial 1 year data
  • 24. Choose your procedure?
  • 25. Flanders study Stenosis Not suitable for CEA 7.5% Not suitable for CAS 12.75% CEA/CAS Patient choice CAS 71% CEA 29%
  • 26. And Now~? • German trial • French Trial • Doubt about safety of CAS
  • 27. EVA-3S (NEJM 2006) • French, Prospective, Randomised • Hypothesis – CAS not inferior to CEA • Symptomatic disease • Assumed 30 day events – CEA 5.6% – CAS 4% • Stopped – Primary end point not reached – Would require 4000 patients (527 randomised)
  • 28. EVA-3S (NEJM 2006) • 30 day CEA CAS All stroke and death 3.9% 9.6% Disabling stroke and death 1.5% 3.45% • Each surgeon – 25 CEA’s in the year before trial • “Interventionalist” – 5 CAS in total • Introduction of protection – Significant reduction in strokes • Drug regime discretionary
  • 29. SPACE (Lancet 2006) • Germany, Austria and Switzerland • Hypothesis – CAS not inferior to CEA • Symptomatic, prospective, randomised • Assumed 5% event rate for both • Plan for 900 patients in each group • 25% of surgeons rejected on track record • 1183 treated – Estimated need for 2500 + • Stopped – Lack of funding
  • 30. SPACE (Lancet 2006) • 30 day stroke and death rate – CEA 6.34% – CAS 6.84% • “CAS not more than 2.5% inferior to CEA” – 91% chance = true – 9% chance = false • Protection used in 25% of CAS patients
  • 31. Meta-analysis
  • 32. Endovascular vs Surgical treatment of Carotid Stenosis: Any Stroke or Death at 30 days – Random effects method Ederle J et al. Cochrane Database of Systematic Reviews: in preparation Random Effects Model: OR 1.44; CI 0.91 – 2.26 Not statistically significant
  • 33. Numbers of patients included in the meta-analysis of Symptomatic Carotid Surgery Trials • P Rothwell et al. Lancet 2003;361:107-116 Carotid surgery versus medical care – Outcomes: 3202 strokes & deaths • J Ederle at al. Cochrane Review in prep. Carotid surgery vs Endovascular treatment – Safety outcomes: 210 strokes & deaths
  • 34. CAVATAS Intention to treat analysis Carotids fit for surgery (n=504) Events within 30 days of treatment Event Endovascular Surgical treatment treatment All strokes*/death 10.0% 9.9% NS * More than 7 days duration Myocardial infarction 0% 0.8% NS Cranial nerve palsy 0% 8.7% <0.0001 Haematoma† 1.2% 6.7% <0.002 †requiring surgery or prolonging stay Lancet 2001;357:1729-1737
  • 35. Endovascular vs Surgical treatment of Carotid Stenosis: Disabling Stroke or Death at 30 days Ederle J et al. Cochrane Database of Systematic Reviews: in preparation Fixed effects Model: OR 1.22; CI 0.83 – 1.80 Not statistically significant
  • 36. Conclusion • The carotid is 25 years behind the coronary • It is catching up fast. • Different vessel and vascular bed (cf diabetes) • The multidisciplinary team • We have a program up and running
  • 37. The present • Symptomatic carotid stenosis >70% (?50%) – CEA or CAS – High risk, then CAS – Get it done within 3 weeks • Asymptomatic carotid stenosis >80% – CEA or CAS – High risk, then should you be doing it at all? • Pre CABG – Do one side if bilateral stenosis – CAS would be a good choice
  • 38. Should we close holes in the heart?
  • 39. Cardiac Sources of Stroke • 20% of neurological events may be cardiac • 40% of neurological events are cryptogenic – ? Are these often cardiac? • Rheumatic heart disease • AF • Cardiomyopathy (clot) • Aortic atheroma • Patent Foramen Ovale
  • 40. Other investigations History suggestive of arrthymia, syncope, cardiac cause, cardio-embolic cause • 12 lead ECG series , may identify PAF • Look for postural hypotension • 24 hour tape • Echo (TTE)
  • 41. Who to investigate for PFO? • Class I – Any age visceral or peripheral embolism – <45 CVA – >45 CVA without risk factors for CVD – Any age if decision re anticoagulation may change • Class IIa – Any age CVA with possible embolic cause 1564 Botali
  • 42. What do we need to know? • How do we diagnose it? • Is there a risk associated with PFO? • Will the risk be reduced by medical therapy? • Will the risk be reduced by closure? • Is closure safe?
  • 43. Incidence • Autopsy study: n=965 – PFO 27% – 34% <30 20% >80 – 3.4mm 5.8mm • Echocardiographic surveillance studies – PFO 8% (2-23%) – ASA 7.1% (3-12%) – MVP 8.9% (5-9%) Hagen et al 1984
  • 44. Diagnosis • TransCranial Doppler 86% • Transthoracic Echo and contrast >90% • TOE and contrast >90% • Two modalities are better than one Heckman et al
  • 45. LV RA RV LA
  • 46. The risk of PFO and stroke • Lechat et al age<55 CVA – Control PFO 10% – All CVA PFO 40% (p<0.001) – Cryptogenic PFO 54% • Mas et al age 18-35 CVA – All CVA PFO 36% NEJM 1988, 2001
  • 47. Meta-analysis • CVA <55 9 studies • PFO OR 3.1 (2.3-4.2) • ASA OR 6.1 (2.5-15) • Both OR 15.6 (2.8-86)
  • 48. What do we need to know? • How do we diagnose it? + • Is there a risk associated with PFO? + • Will the risk be reduced by medical therapy? • Will the risk be reduced by closure? • Is closure safe?
  • 49. Mechanism? • Paradoxical embolism? – Larger hole found in CVA pts vs non-CVA – Residual shunt after closure predicts recurrence – Divers brains and PFO • In situ clot in tract? • Predict atrial arrhythmias? (OR 4.1) • Predict a hypercoagulable state?
  • 50. Medical Therapy • What? – Aspirin or Warfarin • Comess et al n=33 16% pa – No Rx • Mas et al n=132 3.4% pa – Aspirin or warfarin • Lausanne registry 3.8% pa – Aspirin or warfarin
  • 51. Device closure • Meier et al – CVA/TIA • 6.6% pa No Closure • 4.5% pa Closure – Stroke risk • 3% No Closure • 0% Closure • RCT awaited
  • 52. What do we need to know? • How do we diagnose it? + • Is there a risk associated with PFO? + • Will the risk be reduced by medical therapy? + • Will the risk be reduced by closure? ? • Is closure safe?
  • 53. Who to investigate?Who to investigate? • Class IClass I – Any ageAny age visceral or peripheral embolismvisceral or peripheral embolism – <45<45 CVACVA – >45>45 CVA without risk factors for CVDCVA without risk factors for CVD – Any ageAny age if decision re anticoagulation mayif decision re anticoagulation may changechange • Class IIaClass IIa – Any ageAny age CVA with possible embolic causeCVA with possible embolic cause
  • 54. Problems • Failure to deploy <5% • Device embolisation 1% • Thrombus 1-5% • Death 0% • I quote 1% risk from procedure
  • 55. What do we need to know? • How do we diagnose it? + • Is there a risk associated with PFO? + • Will the risk be reduced by medical therapy? + • Will the risk be reduced by closure? ? • Is closure safe? +
  • 56. Who to Close? • None? • All?
  • 57. Conclusion • Closure may well reduce the risk of recurrence and should be considered within 3 months • Divers and those with Migraine deserve special consideration also
  • 58. Conclusions • Investigation and treatment essential • Strokes time as a “cinderella” is over • Worthwhile interventions are available (at a price) • These are worthless without stopping smoking, lipids, BP control etc.
  • 59. Case 1 • 59 year old • Loss of speech and weakness in right hand for 1 hour • No HT/DM/smoking/FH/Lipids/Renal • No cardiac symptoms • MRI confirms single stroke • Carotids OK • Thrombophilia- Anticardiolipin antibody
  • 60. Case 1 • Needs cardiac work-up to exclude – PAF – LAA clot – PFO • PFO found with large shunt. • Close it?
  • 61. Case 2 • 52 year old • One clinical episode of weakness in L arm • No risk factors • MRI shows 5 areas of infarction of similar age on left side • Carotids OK bilaterally
  • 62. Case 2 • Needs investigation for: – PAF – LAA clot – PFO • PFO found • Should close this!
  • 63. Case 3 • 68 yr old • Asian/HT/DM/IHD with CABG • Recurrent TIAs with left sided weakness • Carotids bilateral >80% stenosis
  • 64. Case 3 • Need to exclude PFO, PAF? • Need to treat R carotid urgently – CEA – CAS
  • 65. LAA closure
  • 66. Protect AF • Stroke, CVS death, systemic Embolisation • 707 patients rates per 100 pt yrs • CHADS score 1-3 • Take warfarin for 6 weeks after (95% off it at 6 mo) Watchman Warfarin Death/CVA/ embolisation 3.0 4.9 All stroke 2.6% 3.5% Bleed/PE/ Device gone 7.4 4.4