2006 Considerations for Carotid 2006 Considerations for Carotid

Stenting Credentialing and Practice:Stenting Credentialing and Practice:Training, volume issues, reimbursementTraining, volume issues, reimbursement

Jay S. Yadav MDJay S. Yadav MDCleveland, OHCleveland, OH

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Disclosures

◆ Inventor of Angioguard◆ Advisory Board: Cordis, Abbott

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High-Risk Patient Trials -High-Risk Patient Trials -Carotid Stenting with Emboli Carotid Stenting with Emboli ProtectionProtection

◆ Randomized against SurgeryRandomized against Surgery◆ SAPPHIRESAPPHIRE

◆ Non-Randomized RegistriesNon-Randomized Registries◆ ARCHERARCHER◆ SHELTER / BEACHSHELTER / BEACH◆ MAVERICKMAVERICK◆ CABERNETCABERNET◆ SECURITYSECURITY

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SAPPHIRE STUDYSAPPHIRE STUDYMAEMAE at 360 Days at 360 Days

Rand CEA: 20.1%

Non-Rand Stent: 16.0%

Rand Stent: 12.2%

Non-Randomized Stent Arm vs. Randomized Stent & CEA

Time After Initial Procedure (days)

Cum

ulat

ive

Perc

enta

ge o

f MA

E

Rand CEA: 9.8%

Non-Rand Stent: 6.9%

Rand Stent: 4.8%

Yadav, NEJM, 351: 1493-1501,2004

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Cumulative Percentage of Stroke to 30 Days and Cumulative Percentage of Stroke to 30 Days and Ipsilateral Stroke from 31 to 1080 DaysIpsilateral Stroke from 31 to 1080 Days

Days: 0 360 720 1080

CEA: 167 150 (90%) 134 (80%) 112 (67%)

Stent: 167 161 (96%) 154 (92%) 139 (83%)

Randomized Patients

0

510

15

2025

30

35

4045

50

0 90 180 270 360 450 540 630 720 810 900 990 1080Time (days)

Cum

ulat

ive

% o

f Str

oke

CEA Stent LR p=0.945

Stent 7.1%

CEA 3.0%

Stent 4.9% Stent 6.3%CEA 6.7%Stent 3.6% CEA 5.8% CEA 6.7%

30

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Cumulative Percentage of Target Lesion Cumulative Percentage of Target Lesion Revascularization at 1080 DaysRevascularization at 1080 Days

Randomized Patients

05

1015

20253035

404550

0 90 180 270 360 450 540 630 720 810 900 990 1080Time (days)

Cu

mu

lati

ve %

of

TL

R

CEA Stent LR p=0.084

CEA 7.1%

Stent 3.0%

Days: 0 360 720 1080

CEA: 167 150 (90%) 134 (80%) 112 (67%)

Stent: 167 161 (96%) 154 (92%) 139 (83%)

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4.72.9

1.1 0.7

3.4

0.8 0.50

2.0

0.10

5

10

15

All Stroke Major Ipsi Major Non-Ipsi Minor Ipsi Minor Non-Ipsi

Symptomatic (n=274)Asymptomatic (n=974)

%

Stroke at 30-Days Symptomatic vs. Asymptomatic

CASES -PMS

Adjudicated data

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SapphireSapphire BeachBeachArcherArcher SecuritySecurityMavericMaveric CabernetCabernet

World RegistryWorld RegistryCarotid StentingCarotid Stenting

2,400 patients2,400 patients

11,035 patients11,035 patients

16,070 patients16,070 patients

How much more data do we need?!?!How much more data do we need?!?!

German Carotid RegistryGerman Carotid Registry 2,427 patients2,427 patients

High Risk Trials/Registries:High Risk Trials/Registries:

Low to Moderate Risk Low to Moderate Risk PatientsPatients

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Moderate Risk Patients – Moderate Risk Patients – CREST Lead InCREST Lead In

30 day Stroke/Death30 day Stroke/Death

◆ 527 Pts527 Pts 3.4%3.4%◆ AsxAsx 2.4%2.4% <ACAS <ACAS ◆ SxSx 5.6%5.6% <NASCET<NASCET◆ < 60 yrs: < 60 yrs: 2% 2%

◆ Lenox Hill 187 ptsLenox Hill 187 pts 1.6% 1.6%

Hobson, AHA 2003Hobson, AHA 2003

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CARESS Lead In – Low CARESS Lead In – Low RiskRisk

30 Day Events30 Day EventsCEACEA StentStent

Stroke/DeathStroke/Death 2%2% 2%2%Stroke/Death/MIStroke/Death/MI 3%3% 2%2%

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Who Should Treat Patients Who Should Treat Patients with Carotid Disease ?with Carotid Disease ?

◆ CardiologistsCardiologists◆ RadiologistsRadiologists◆ SurgeonsSurgeons◆ NeurologistsNeurologists◆ Vascular InternistsVascular Internists

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COCATSCOCATSACC March 2002

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Worldwide RegistryWorldwide Registry

6 3 %

2 5 %

1 2 %0%

25%

50%

75%

C A R D I O L O G Y R A D I O L O G Y S U R G E R Y

Carotid Stent by Physician SpecialtyCarotid Stent by Physician Specialty

Wholey and Wholey; Cath and Cardiovascular Intervent;1998.Wholey and Wholey; Cath and Cardiovascular Intervent;1998.

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Credentials = PrivilegesCredentials = Privileges

◆ Local hospital function.Local hospital function.◆ Rules apply equally to all Rules apply equally to all

specialties.specialties.◆ Quality assurance function.Quality assurance function.

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Certification = GuidelinesCertification = Guidelines

◆ Professional societies or associations.Professional societies or associations.◆ Payers.Payers.◆ Government agencies.Government agencies.

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CERTIFYING CERTIFYING ORGANIZATIONSORGANIZATIONS

◆ ACC/AHAACC/AHA◆ SCAI SCAI (Society of Cardiac Angiography and Intervention).(Society of Cardiac Angiography and Intervention).

◆ ISCI ISCI (International Society of Cardiovascular (International Society of Cardiovascular Interventionists).Interventionists).

◆ SIR SIR (Society of Interventional Radiologists).(Society of Interventional Radiologists).

◆ SVS SVS (Society of Vascular Surgery).(Society of Vascular Surgery).

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Cognitive: Cognitive: The fund of knowledge for vascular disease, natural history, The fund of knowledge for vascular disease, natural history,

pathophysiology, diagnostic methods, and treatment pathophysiology, diagnostic methods, and treatment

alternatives. alternatives.

Technical:Technical: Competence in both diagnostic angiography and Competence in both diagnostic angiography and

interventional techniques.interventional techniques.

Clinical:Clinical: The ability to manage inpatients, interpret diagnostic tests, The ability to manage inpatients, interpret diagnostic tests,

obtain consent, admittingobtain consent, admitting privileges, assessment of risk to privileges, assessment of risk to

benefit ratio.benefit ratio.

REQUIRED SKILL ELEMENTSREQUIRED SKILL ELEMENTSENDOVASCULAR COMPETENCEENDOVASCULAR COMPETENCE

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200 cerebral angiograms 5 carotid stents

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Background of Interventional Experience30 cerebral angiograms - half as primary operator25 carotid stents - half as primary operator

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AHA/ACC GUIDELINES FOR PTAAHA/ACC GUIDELINES FOR PTA(1993)(1993)

◆ AHA/ACC CRITERIA.AHA/ACC CRITERIA.◆ 100 diagnostic angiograms with 50 as 1º 100 diagnostic angiograms with 50 as 1º

operator.operator.◆ 50 PTA’s with 25 as 1º operator.50 PTA’s with 25 as 1º operator.◆ No distribution requirements.No distribution requirements.◆ No threshold event rate.No threshold event rate.◆ Not specialty specific.Not specialty specific.◆ Completely arbitrary criteria.Completely arbitrary criteria.

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Ideal Cardiology Carotid CriteriaIdeal Cardiology Carotid Criteria

◆ Experienced interventional cardiologist (≥ 200 coronary interventions).Experienced interventional cardiologist (≥ 200 coronary interventions).◆ Skilled with SVG-EPD’s (≥ 20 cases).Skilled with SVG-EPD’s (≥ 20 cases).◆ Credentialed to perform non-coronary angiography and angioplasty.Credentialed to perform non-coronary angiography and angioplasty.◆ Committed to carotid “fund of knowledge”.Committed to carotid “fund of knowledge”.

◆ Neurology/Vascular medicine/surgeon partner.Neurology/Vascular medicine/surgeon partner.◆ Attendance at live demonstration course.Attendance at live demonstration course.

◆ Carotid angiograms ≥ 50 proctored cases with stroke and death rate ≤ 1%.Carotid angiograms ≥ 50 proctored cases with stroke and death rate ≤ 1%.◆ 1 month, 6 month, 12 month, and with annual review.1 month, 6 month, 12 month, and with annual review.◆ Proctoring/case review for threshold rate achieved.Proctoring/case review for threshold rate achieved.

◆ Carotid stents with EPD ≥ 25 proctored cases with stroke and death rate ≤ 5%.Carotid stents with EPD ≥ 25 proctored cases with stroke and death rate ≤ 5%.◆ 1 month, 6 month, 12 month, and with annual review.1 month, 6 month, 12 month, and with annual review.◆ Proctoring/case review for threshold rate achieved.Proctoring/case review for threshold rate achieved.

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Ranges of simulationsRanges of simulations

Manikin-based simulations use a plastic manikin with sophisticated software, dedicated workstations and realistic tactile feedback.

                              

These $10MM flight simulators are used to train airline pilots from around the world and they exactly replicate the flight deck of the real aircraft, with sophisticated views of the outside world.

Visual Simulations

Visual Simulations allow users to interact with virtual representations of types of input/output criteria, with multiple branches.

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EducationEducation

◆ Cardiologists and SurgeonsCardiologists and Surgeons◆ Active Training ProgramActive Training Program◆ FDA will Mandate Training FDA will Mandate Training ◆ Medical SimulationMedical Simulation

◆ Simbionix, Mentice, SimSuiteSimbionix, Mentice, SimSuite◆ Vascular and CoronaryVascular and Coronary◆ Fellow EducationFellow Education

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CAPTURE: Primary Safety Events by CAPTURE: Primary Safety Events by Physician Experience Level Physician Experience Level

CAPTURE (N=1603)

HighN=166

MediumN=1177

LowN=260

Deatha. 0.0% 1.6% 2.3%

Strokea.

Major Minor

5.4%1.2%4.2%

3.7%1.7%2.0%

4.6%2.7%1.9%

MIa. 0.6% 0.8% 1.2%S/D/MIb 6.0% 4.8% 5.8%

S/Db 5.4% 4.3% 5.0%

a.Non-hierarchicalbHierarchical

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3.04.1

0.4

4.35.8

3.74.5

0.8 0.61.9

0 0.70

5

10

15Operator Volume High: >75 CAS/year (n=640)

Operator Volume Medium: 25-75 CAS/year (n=468)

Operator Volume Low: <25 CAS/year (n=134)

%

Major Adverse Events at 30-Days

Death MI MAEStroke

Operator Volume

CASES -PMS

Adjudicated data

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FDA FDA

◆ SAPPHIRE high risk criteriaSAPPHIRE high risk criteria◆ Symptomatic 50% stenosisSymptomatic 50% stenosis◆ Asymptomatic 80% stenosisAsymptomatic 80% stenosis

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CMSCMS

◆ SAPPHIRE High RiskSAPPHIRE High Risk◆ Symptomatic 70%Symptomatic 70%

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7.5%6.5%

5.5%

0.0%0%

2%

4%

6%

8%

10%

12%

14%

SAPPHIRE SYMPRand

SAPPHIRE SYMPNon-Rand

NASCET ECST

30-Day Ipsilateral Stroke

STENTING vs OTHER SURGICAL TRIALSSTENTING vs OTHER SURGICAL TRIALSSymptomatic Symptomatic PatientsPatients

Error Bar = 95% CIError Bar = 95% CI

%

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2.5%1.8%

3.2%4.3%

0%

2%

4%

6%

8%

10%

SAPPHIRE ASYMPRand

SAPPHIRE ASYMPNon-Rand

ACAS ACST

30-Day Ipsilateral Stroke

STENTING vs OTHER SURGICAL TRIALSSTENTING vs OTHER SURGICAL TRIALSAsymptomaticAsymptomatic Patients Patients

Error Bar = 95% CIError Bar = 95% CI

%

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30-Day Risk of Stroke in 30-Day Risk of Stroke in High Risk Carotid Stenting TrialsHigh Risk Carotid Stenting Trials

0

2

4

6

8

10

12

14

Patie

nts

(%)

Patie

nts

(%)

3.1%

ARCHeRARCHeR 22SAPPHIRE

Rand Non-RandSECuRITYSECuRITYBEACHBEACH

4.9%5.8%

3.3%Ipsil

4.2% 3.2%DeviceOnly

6.2%

MavericMaveric 22

CabernetCabernet

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-$10,000

-$5,000

$0

$5,000

$10,000

-0.5 -0.25 0 0.25 0.5

∆ Quality-Adjusted Life Expectancy (yrs)

LIFETIME Cost and QALYs

$50,000/QALY

Base Case∆ Cost = $3515

∆ Life Exp = 0.179 QALYsC/E ratio = $19,652/QALY

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CMS PositionCMS Position

◆ CEA Reimbursed:CEA Reimbursed:◆ Any PatientAny Patient◆ Sx > 50%Sx > 50%◆ Asx > 60%Asx > 60%

◆ CAS Reimbursed:CAS Reimbursed:◆ Sx > 70% High RiskSx > 70% High Risk

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CMS PositionCMS Position

More Invasive Procedure (CEA)More Invasive Procedure (CEA)

Less InvasiveProcedure

(CAS)

CAROTIDCAROTID

DISEASEDISEASE

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CLINICAL CLINICAL CONSEQUENCE?CONSEQUENCE?

◆ Medicare patients will continue to get Medicare patients will continue to get CEA when they could benefit from a CEA when they could benefit from a less invasiveless invasive treatment which is treatment which is at at leastleast as safe as CEA. as safe as CEA.

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More Data?More Data?

◆ Low Risk Asymptomatic and Low Risk Asymptomatic and Moderate Stenosis Symptomatic Trials Moderate Stenosis Symptomatic Trials BUT they are randomized to CEA BUT they are randomized to CEA

◆ CMS is taking the position that CEA is CMS is taking the position that CEA is not Proven in these Patientsnot Proven in these Patients

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What Can You Do?What Can You Do?

◆ Express your opinionExpress your opinion◆ steve.phurrough@cms.hhs.govsteve.phurrough@cms.hhs.gov

◆ Medical Societies need to speak with Medical Societies need to speak with one voiceone voice

◆ Educate Your Patients, Congressional Educate Your Patients, Congressional RepresentativesRepresentatives

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CONCLUSIONS:CONCLUSIONS:High Risk PatientsHigh Risk Patients

◆ Protected Carotid Stenting is Protected Carotid Stenting is Superior to CEA in Pts with Co-Superior to CEA in Pts with Co-Morbid ConditionsMorbid Conditions

◆ Protected Stenting: Lower risk of Protected Stenting: Lower risk of Major Ipsilateral Stroke, MI, CN Major Ipsilateral Stroke, MI, CN Injury and RevascularizationInjury and Revascularization

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ConclusionsConclusions

◆ Credentialing Criteria Have Been Credentialing Criteria Have Been DevelopedDeveloped

◆ Training Programs – Industry Training Programs – Industry Sponsored, FDA MandatedSponsored, FDA Mandated