An Update on Carotid Artery PTAS Contemporary Results, Trends, and Challenges

1. An Update on Carotid Artery PTASContemporary Results, Trends, and Challenges Matthew S. Edwards, M.D. Assistant Professor of Surgery Wake Forest University School of Medicine Winston-Salem, North Carolina SAVS Postgraduate Course January 2006

2. An Update on Carotid Stenting • Rationale for treatment of carotid stenosis • Reduce risk of subsequent stroke • Rationale for CAS in lieu of CEA • Less invasive • ? Lower risk of adverse outcomes • Stroke • Death • Procedural morbidity • ? Less Cost

3. An Update on Carotid Stenting • American Heart Association Guidelines • Asymptomatic Patients • For treatment of 60% or greater stenosis • Perioperative stroke/death must be less than 3% • Symptomatic Patients • For treatment of 50% or greater stenosis • Perioperative stroke/death must be less than 6% • No proven indications beyond these thresholds Biller et al, Circulation 1998

4. An Update on Carotid Stenting • Update on Contemporary Data • Clinical Trials • Recent CREST Results • Cochrane Review • Update on Contemporary Trends • Embolic Protection • Update on Contemporary Challenges • Credentialing • Program establishment

5. An Update on Carotid Stenting Contemporary Trial Results

6. An Update on Carotid Stenting

7. An Update on Carotid Stenting Perioperative Adverse Events

8. An Update on Carotid Stenting

9. An Update on Carotid Stenting 30 Day Results

10. An Update on Carotid Stenting One (*Three) Year Results

11. An Update on Carotid Stenting • Recent CREST data • Rates of Stroke/Death • Age less than 60: 1.7% • Ages 60-69: 1.3% • Ages 70-79: 5.3% • Ages 80-89 : 12.1% • Recent CREST Advisory • Age>80 • Extreme tortuosity • Severe calcification • Limited cerebral reserve Hobson et al, Journal of Vascular Surgery 2004

12. An Update on Carotid Stenting • Cochrane Review • Essentially a meta-analysis • Extensively used by Insurers and Health Plan Managers in defining benefits • Conclusions • Insufficient evidence to recommend change in current practice of CEA as treatment of choice • CAS should only be offered as part of ongoing randomized trials of CEA v CAS Coward et al, Stroke 2005

13. An Update on Carotid Stenting Contemporary Trends and Controversies

14. An Update on Carotid Stenting • Embolic Protection • Are emboli really a problem? • DEP devices • Which is better? • Anticoagulation • Heparin v Bivalirudin • Antiplatelet agents

15. An Update on Carotid Stenting • Emboli- Are they really a problem? • Reasonable results in CAS without DEP but CAVATAS strongly weighs in favor of use • Bibl, Neurology 2005 • Large volume of work demonstrating debris & infarcts • Debris captured in 70-95% of cases • Reimers et al, Am J Cardiol 2005; Hammer et al, JVS 2005 • 30-40% of CAS procedures demonstrate infarcts • Cosottini et al, Stroke 2005; Hammer et al, JVS 2005 • Over half of infarcts ‘inconsistent’

16. An Update on Carotid Stenting • DEP devices • Filters • Porosity 100-150 µm • Distal occlusion • Flow reversal

18. An Update on Carotid Stenting • DEP use in CAS • Accepted despite lack of level I evidence • No controlled data demonstrating superior efficacy of any particular design • Several reviews suggest equivalent efficacy for filters and distal occlusion DEP • Zahn et al, J Am Coll Cardiol 2005; • Arjomand et al J Am Coll Cardiol 2005

19. An Update on Carotid Stenting • Embolic Protection- Medical Adjuncts • Aspirin and clopidogrel accepted adjuncts • Use required in CREST • Most use 3-7 days prior • Continue for at least 28 days post • ASA lifetime • Glycoprotein IIbIIIa inhibitors • Less efficacious than DEP • Higher risk of adverse outcome • Chan et al, Am J Cardiol 2005

20. An Update on Carotid Stenting Credentialing and Program Necessities

21. An Update on Carotid Stenting Credentialing

22. An Update on Carotid Stenting • Credentialing • Highly politicized and contentious • Two main sets of ‘consensus’ documents • SVS/SCAI/SVMB • ASITN/ASN/SIR/AAN/AANS/CNS • Local decisions still made at hospital level • Major points • Cognitive Skills • Technical Skills • Clinical Skills

23. SCAI/SVMB/SVS Cognitive Requirements • Pathophysiology of carotid artery disease and stroke • Clinical manifestations of stroke • Natural history of carotid artery disease • Associated pathology • Diagnosis of stroke and carotid artery disease • Angiographic anatomy • Alternative treatment options • Case selection • Role of post procedure f/u and surveillance Creager MA, Vascular Medicine 2004; Clinical Competence Statement, Vascular Medicine 2005

24. SCAI/SVMB/SVS Technical Requirements • Expertise with antiplatelet therapy and procedural anticoagulation • Angiographic skills • Interventional skills • Recognition and management of procedural complications • Cerebrovascular events • Cardiovascular events • Vascular access events • Management of vascular access Creager MA, Vascular Medicine 2004; Clinical Competence Statement, Vascular Medicine 2005.

25. Creager MA, Vascular Medicine 2004; Clinical Competence Statement, Vascular Medicine 2005; Connors JJ, JVIR 2004.

26. Clinical Skills • Determine the patient’s risk/benefit for the procedure • Outpatient responsibilities • Medication management • Counseling • Inpatient responsibilities • Coordination of post-stent surveillance and clinical outpatient follow-up Creager MA, Vascular Medicine 2004; Clinical Competence Statement, Vascular Medicine 2005.

27. An Update on Carotid Stenting Program Necessities

28. An Update on Carotid Stenting • Current Medicare Coverage • Patients at ‘high-risk’ for CEA and ≥70% carotid stenosis with symptoms • As part of Category B IDE clinical trials or post-approval trials • 50% or greater carotid stenosis with symptoms • 80% or greater carotid stenosis without symptoms CMS Manual System. Transmittal 531. April 2005.

29. An Update on Carotid Stenting • High risk for CEA defined as • Class III/IV CHF • LVEF <30% • Unstable angina • Contralateral carotid occlusion • Recent MI • Previous CEA with recurrent stenosis • Prior neck radiation • COPD • Contralateral laryngeal nerve palsy CMS Manual System. Transmittal 531. April 2005.

30. An Update on Carotid Stenting • Facility requirements • High quality x-ray imaging • In-suite advanced physiologic monitoring • Emergency management equipment and personnel • Clearly delineated program for granting privileges • Maintenance of data registry with at least biannual reviews • CMS certification CMS Manual System. Transmittal 531. April 2005.

31. An Update on Carotid Stenting • CMS certification • FDA approved site for prior IDE trials • SAPPHIRE, ARCHER, BEACH • FDA approved site for ongoing IDE trials • CREST • FDA approved site for post-approval studies CMS Manual System. Transmittal 531. April 2005.

32. An Update on Carotid Stenting • CMS certification (cont’d) • Written affidavit to CMS containing • Facility name and address • Facility Medicare provider number • Point of contact and contact info • Mechanism of data collection for CAS procedures • http://www.vascularweb.org/_CONTRIBUTION_PAGES/Practice_Issues/Vascular_Registry/Carotid_Registry.html • Signature of senior facility administrative official CMS Manual System. Transmittal 531. April 2005.

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