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

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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
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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

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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

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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

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An Update on Carotid Stenting

• Contemporary Trial Results

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An Update on Carotid Stenting
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An Update on Carotid Stenting
Perioperative Adverse Events
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An Update on Carotid Stenting
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An Update on Carotid Stenting
30 Day Results
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An Update on Carotid Stenting
One (Three) Year Results
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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
• Agegt80
• Extreme tortuosity
• Severe calcification
• Limited cerebral reserve

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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

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An Update on Carotid Stenting

• Contemporary Trends and Controversies

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An Update on Carotid Stenting

• Embolic Protection
• Are emboli really a problem?
• DEP devices
• Which is better?
• Anticoagulation
• Heparin v Bivalirudin
• Antiplatelet agents

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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

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An Update on Carotid Stenting

• DEP devices
• Filters
• Porosity 100-150 µm
• Distal occlusion
• Flow reversal

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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

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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

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An Update on Carotid Stenting

• Credentialing and Program Necessities

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An Update on Carotid Stenting

• Credentialing

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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

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• 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

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• 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

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• Clinical Skills
• Determine the patients risk/benefit for the
  procedure
• Outpatient responsibilities
• Medication management
• Counseling
• Inpatient responsibilities
• Coordination of post-stent surveillance and
  clinical outpatient follow-up

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An Update on Carotid Stenting

• Program Necessities

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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

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An Update on Carotid Stenting

• High risk for CEA defined as
• Class III/IV CHF
• LVEF lt30
• Unstable angina
• Contralateral carotid occlusion
• Recent MI
• Previous CEA with recurrent stenosis
• Prior neck radiation
• COPD
• Contralateral laryngeal nerve palsy

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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

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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

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An Update on Carotid Stenting

• CMS certification (contd)
• 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/Pra
  ctice_Issues/Vascular_Registry/Carotid_Registry.ht
  ml
• Signature of senior facility administrative
  official

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