1. Emerging Techniques For Management of Carotid and Brachiocephalic Occlusive Disease for Prevention of Stroke Brian Whang, Romeo Mateo, Anthony Pucillo, Jose Botet, Jiyoong Ahn, Hughes, Albert DeLuca, Arun Goyal, Pravin Shah, Sateesh Babu New York Medical College

2. The Problem

3. STROKE

4. Epidemiology Stroke: Third leading cause of death in the U.S. 700,000 incident strokes annually 4.4 million stroke survivors $51 Billion – cost for 1999 Up to 20% due to carotid atherosclerosis Stroke 2001;32:280-299 Annals of Neurology 1989;25:382-90

5. Carotid Endarterectomy As of May 29, 2002 the standard of care for the treatment of symptomatic and asymptomatic cervical carotid artery disease in good risk patients remains the carotid endarterectomy (CEA).

6. Extracranial Carotid Artery Disease

10. CEA in High-Risk Patients Cleveland Clinic Experience: 1988-1998 Stroke, Death, & MI rate High Risk (n=594)7.4% Low Risk (n=2467)2.9%

12. Minimally Invasive Technology Angioplasty and stenting Proven efficacy and durability Feasible alternative to high-risk surgery Applicable to lesions of the carotid and brachiocephalic arteries?

13. Methods 30-month period Multidisciplinary Team Approach Patient Population: –74 patients –37 male, 37 female –Mean age: 66 years old –Symptomatic or asymptomatic stenosis –High risk for CEA (for ICAS)

14. Methods (continued) Angiographic Indications for Stenting –Symptomatic  70% stenosis –Symptomatic  50% + contralateral occlusion –Asymptomatic  80% stenosis –Asymptomatic  60% + contralateral occlusion

15. Methods (continued) High Risk Indications for Stenting: –Prior CEA with significant restenosis –Hostile neck: Prior cervical radiation with tissue injury Radical neck dissection or significant ipsilateral neck surgery Cervical spine disease or fixation preventing extension beyond neutral position

16. Methods (continued) High Risk Indications for Stenting: Anatomic Difficulty –Carotid lesions at the ostium or origin of the CCA –Lesions higher than C2 or C3 cervical vertebrae –Severe tandem ICA and CCA lesions in patients with significant co-morbidities –Symptomatic carotid artery dissection

17. Methods (continued) High Risk Indications: Co-morbid Conditions Increasing Risk of CEA –Unstable Angina –Recent MI / Critical CAD –Class III or IV CHF –Severe pulmonary disease –Uncontrolled DM –Bleeding diathesis –Contralateral laryngeal nerve palsy

18. Contraindications to Carotid Artery Stenting Severe tortuosity Intraluminal filling defect Occlusion of CCA or ICA Cerebral aneurysm, AVM, or tighter intracranial stenosis Major ipsilateral stroke (likely to confound study endpoints) Severe neurological illness within the last two years

19. ICAS Patient Characteristics (as of 04/02) Asymptomatic40 Symptomatic: TIA / Amaurosis11 CVA 2 VB0

20. Patient Characteristics (continued) ICAS High-Risk Category ICAS High-Risk Category (patients may have more than one risk factor) Recurrent s/p CEA26 Cardiac20 Respiratory 3 Neck XRT 7 High Lesion 5 ESRD 4

21. Patient Characteristics (continued) Total # of VESSELS75 ICA53 L CCA 1 L CCA + L SCA 2 L SCA13 Innominate 4

22. Stenting Methods ICAS Technique: 1. Wire ECA 2. 6 or 7 Fr Shuttle Sheath to CCA 3. Predilate with 4 x 4 cm coronary balloon 4. 10 x 20 Wallstent or SMART-18 stent 5. Post-dilate with 5 x 2 cm coronary balloon

23. Carotid Artery Stenting Pre-stent Post-stent Pre-stent Post-stent

24. Carotid Artery Stenting 42 year-old woman with a history of cancer treatment involving neck radiation therapy. She has been having crescendo TIAs of left arm weakness. Stent

25. Common Carotid Artery Stenting Post-stent Pre-stent Pre-stent

26. Tortuousity Precluding Use of Carotid Stent

27. Brachiocephalic & Carotid Stenting Data (as of 04/02) ICAS Total # of Procedures54 Male32 Female21 Failed 1 Technical Success98% (53/54)

28. Brachiocephalic & Carotid Stenting Data (as of 04/02) BCAS Total # of Procedures20 Male 5 Female15 Failed 0 Technical Success100%

29. ICAS Results (as of 04/02) ICASTotal54 Technical Success98% (53/54) Stroke3.8% (2/53) 1 Expressive Aphasia 1 Retinal Embolus Deaths0 Myocardial Infarctions0

30. BCAS Results (as of 04/02) BCAS Total20 Technical Success100% Stroke0 Deaths0 Myocardial Infarctions0

31. “Outcomes mean everything.” Norman Hertzer, M.D. Stroke/Death Rate CEA in high risk patients7.4% ICAS: –Lenox Hill- first 99 cases7.1 –Worldwide experience – first 5010.1 –Lenox Hill –Case #443-6044.3 –Worldwide- Case #300-9004.1 –Westchester High Risk ICAS (53 cases)3.8%

32. Carotid Stenting Follow-up: Restenosis (as of 04/02) ICAScases followed up:53 Duration-mean17.5 months Degree of restenosis (by duplex):# Cases 0-15%37 16-49%10 50-79% 4 80-99% 2* * Angiographically proven to be only 40-50 % restenosed

33. Recommendations Carotid disease in good-risk patients--> CEA Carotid disease in good-risk patients--> CAS only in randomized trials High-risk patients --> CEA with cervical block or intensive monitoring Higher-risk patients --> CAS only under strict protocols or randomized trials

34. Conclusions Endovascular treatment of carotid and brachiocephalic occlusive disease is a viable option for the treatment of patients at high risk for standard operative repair. A multidisciplinary approach and rigid patient selection are critical for success.