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An Update on Carotid Artery PTAS Contemporary Results, Trends, and Challenges Matthew S. Edwards, M.D. Assistant Professor of Surgery Wake Forest University.

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Presentation on theme: "An Update on Carotid Artery PTAS Contemporary Results, Trends, and Challenges Matthew S. Edwards, M.D. Assistant Professor of Surgery Wake Forest University."— Presentation transcript:

1 An Update on Carotid Artery PTAS Contemporary 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 stenosisRationale for treatment of carotid stenosis –Reduce risk of subsequent stroke Rationale for CAS in lieu of CEARationale for CAS in lieu of CEA –Less invasive –? Lower risk of adverse outcomes StrokeStroke DeathDeath Procedural morbidityProcedural morbidity –? Less Cost

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

4 An Update on Carotid Stenting Update on Contemporary DataUpdate on Contemporary Data –Clinical Trials –Recent CREST Results –Cochrane Review Update on Contemporary TrendsUpdate on Contemporary Trends –Embolic Protection Update on Contemporary ChallengesUpdate on Contemporary Challenges –Credentialing –Program establishment

5 An Update on Carotid Stenting Contemporary Trial Results

6 An Update on Carotid Stenting High Risk TypeNASx % Stenosis Sx % Stenosis DEPASx Pts. Sx Pts. CAVATASNPRCT504>60%>50%N10%90% SAPPHIREYPRCT334>80%>50%Y30%70% CaRESSNPNRCT397>75%>50%Y32%68% MAVErICYRegistry399>80%>50%YNR BEACHYRegistry480>80%>50%Y24%76% CRESTNPRCT2500>80%>50%Y~30%~70%

7 An Update on Carotid Stenting nStrokeDeathMIS/D/MI CAVATAS 5048%3%0%10% SAPPHIRE %1.2%2.4%4.8% CaRESS %0% 2.1% MAVErIC 3993%1%N/R5% BEACH %1.5%0.8%5.4% Perioperative Adverse Events

8 An Update on Carotid Stenting nSx S/D/MIASx S/D/MI CAVATAS 50410%N/R SAPPHIRE %5.4% CaRESS % BEACH %4.4% NASCET %N/A ACAS 1662N/A2.3% ACST 3120N/A3.1%

9 An Update on Carotid Stenting S/DS/D/MI CEACASPCEACASP CAVATAS 10% NS11%10%NS SAPPHIRE 5.6%4.8%NS9.8%4.8%0.06 CaRESS 3.6%2.1%NS4.4%2.1%NS 30 Day Results

10 An Update on Carotid Stenting S/DS/D/MI CEACASPCEACASP CAVATAS* 14.3%14.2%NSN/R N/A SAPPHIRE 8.4%5.5%NS20.1%12.2%0.05 CaRESS 13.6%10%NS14.3%10.9%NS One (*Three) Year Results

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

12 Coward et al, Stroke 2005 An Update on Carotid Stenting Cochrane ReviewCochrane 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 choiceInsufficient 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 CASCAS should only be offered as part of ongoing randomized trials of CEA v CAS

13 An Update on Carotid Stenting Contemporary Trends and Controversies

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

15 An Update on Carotid Stenting Emboli- Are they really a problem?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 casesDebris captured in 70-95% of cases –Reimers et al, Am J Cardiol 2005; Hammer et al, JVS % of CAS procedures demonstrate infarcts30-40% of CAS procedures demonstrate infarcts –Cosottini et al, Stroke 2005; Hammer et al, JVS 2005 Over half of infarcts ‘inconsistent’Over half of infarcts ‘inconsistent’

16 An Update on Carotid Stenting DEP devices –Filters Porosity µm –Distal occlusion –Flow reversal

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18 An Update on Carotid Stenting DEP use in CASDEP 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 AdjunctsEmbolic Protection- Medical Adjuncts –Aspirin and clopidogrel accepted adjuncts Use required in CRESTUse required in CREST Most use 3-7 days priorMost use 3-7 days prior Continue for at least 28 days postContinue for at least 28 days post ASA lifetimeASA lifetime –Glycoprotein IIbIIIa inhibitors Less efficacious than DEPLess efficacious than DEP Higher risk of adverse outcomeHigher 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 CredentialingCredentialing –Highly politicized and contentious –Two main sets of ‘consensus’ documents SVS/SCAI/SVMBSVS/SCAI/SVMB ASITN/ASN/SIR/AAN/AANS/CNSASITN/ASN/SIR/AAN/AANS/CNS –Local decisions still made at hospital level –Major points Cognitive SkillsCognitive Skills Technical SkillsTechnical Skills Clinical SkillsClinical Skills

23 Creager MA, Vascular Medicine 2004; Clinical Competence Statement, Vascular Medicine 2005 SCAI/SVMB/SVS Cognitive RequirementsSCAI/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

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

25 Creager MA, Vascular Medicine 2004; Clinical Competence Statement, Vascular Medicine 2005; Connors JJ, JVIR SCAI/SVMB/SVSAAN/AANS/ASITN/ASN/ CNS/SIR # Non carotid angiograms 100 (50 as primary operator) 100 (50 as primary operator) # Non carotid interventions 50 (25 as primary operator) 50 (25 as primary operator) # Carotid angiograms 30 (15 as primary operator) 100 (50 as primary operator) # Carotid stents 25 (half as primary) 25 non-CAS + 4 CAS OR 10 CAS

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

27 An Update on Carotid Stenting Program Necessities

28 CMS Manual System. Transmittal 531. April An Update on Carotid Stenting Current Medicare CoverageCurrent 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 symptoms50% or greater carotid stenosis with symptoms 80% or greater carotid stenosis without symptoms80% or greater carotid stenosis without symptoms

29 CMS Manual System. Transmittal 531. April An Update on Carotid Stenting High risk for CEA defined asHigh 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

30 CMS Manual System. Transmittal 531. April An Update on Carotid Stenting Facility requirementsFacility 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

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

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

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