Risk Stratification of Coronary Artery Disease with Nuclear Cardiology

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OPTIMAL SYSTEMS, OPTIMAL CAREPartnerships for
Transformation Systematic Appropriateness
OVERVIEW OF APPROPRIATENESS CRITERIA Medical
Directors Institute 2006 Robert Hendel, M.D.,
F.A.C.C., F.A.S.N.C., F.A.H.A. Midwest Heart
Specialists Fox River Grove, Illinois
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WHY APPROPRIATENESS?Background

• Unprecedented focus on assessment and improving
  quality
• Explosive growth of CV imaging

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MEDICARE PAYMENT ADVISORY COMMISSION (MEDPAC)
EVALUATION OF THE GROWTH IN PHYSICIAN
SERVICES1999 - 2003
Growth of All Physician Services
22

Includes all Services in the Physician Fee
Schedule Source Adapted from MEDPAC Analysis of
Medicare Claims Data March 17, 2005, Executive
Director, Medicare Payment Advisory Commission,
Mark Miller
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WHY APPROPRIATENESS?Background

• Unprecedented focus on assessment and improving
  quality
• Explosive growth of CV imaging

• Substantial regional variation
• True nature of utilization unknown
• Overuse/ Underuse/Appropriate
• Clinicians, patients, and especially payers
  seeking guidance

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GEOGRAPHIC VARIATIONS IN IMAGING STRESS TESTING
PROCEDURE RATES
Median 10 / 1000 Range 10-120
Wennberg, D. The Dartmouth Atlas of
Cardiovascular Health Care 1999 60-61
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GUIDELINES, MEASURES, AND APPROPRIATENESS CRITERIA

• Clinical Guidelines1
• Exhaustive review of literature
• Virtually all-inclusive
• Best practice
• Should do, should not do
• Performance Measures2
• Selective, focused, measurable
• Based on guidelines
• Must do
• Tools for quality measurement
• Appropriateness Criteria3
• Selective indications
• Largely guideline based
• Clinical scenarios
• Reasonable to do

1. Klocke FJ, Baird MG, Lorell BH, et al.
ACC/AHA/ASNC guidelines for the clinical use of
cardiac radionuclide imaging. Circulation 2003
106 1883-92 2. Krumholtz HM, Anderson JL,
Brooks, et al. ACC/AHA clinical performance
measures for adults with ST-elevation and
non-ST-elevation myocardial infarction. J Am Coll
Cardiol 2006 47 236-65. 3. Brindis RG,
Douglas PS, Hendel RC et al. ACCF/ASNC
appropriateness criteria for single-photon
emission computed tomography myocardial perfusion
imaging. J Am Coll Cardiol 2005 46 1587-605.
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POTENTIAL ATTRIBUTES OFAPPROPRIATENESS CRITERIA

• Consistent with existing guidelines and
  performance measures
• Blending of clinical experience and
  evidence-based practice
• Focus on diagnostic and therapeutic procedures
• Applicable to different care environments
• Account for patient/family values, preferences,
  goals
• Consider co-morbidities
• Benefit versus risk
• Simple,reliable, valid, and transparent

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WHAT IS AN APPROPRIATE IMAGING STUDY?

• An appropriate imaging study is one in which the
  expected incremental information, combined with
  clinical judgment, exceeds the expected negative
  consequences by a sufficiently wide margin for a
  specific indication that the procedure is
  generally considered acceptable care and a
  reasonable approach for the indication.
• Negative consequences include the risks of the
  procedure (i.e., radiation or contrast exposure)
  and the downstream impact of poor test
  performance such as delay in diagnosis (false
  negatives) or inappropriate diagnosis (false
  positives).

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APPROPRIATENESS OF CARDIOVASCULAR IMAGINGRanking
of Indications

• 7-9 Appropriate test for specific indication
• Test is generally acceptable and is a reasonable
  approach for the indication
• 4-6 Uncertain or unclear if appropriate for
  specific indication
• Test may be generally acceptable and may be a
  reasonable approach for the indication
• 1-3 Inappropriate test for specific indication
• Test is not generally acceptable and is not a
  reasonable approach for the indication

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DETERMINATION OF APPROPRIATENESS SCORE
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METHOD FOR DETERMINING CARDIOVASCULAR IMAGING
APPROPRIATENESS Appropriateness per Modality

• Step 1 Develop list of specific clinical
  indications and review literature for an imaging
  modality
• Step 2 Expert Panel (n9-15) Review of clinical
  indications and ratings
• Step 3 Expert Panel Meeting and discussion
  followed by re-ratings
• Step 4 Tabulation of appropriateness
  recommendations for one imaging modality across
  multiple indications.
• Consensus score
• Clear link to level of evidence for each
  indication

Patel MR, et al. JACC46 1606-1613
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METHOD FOR DETERMINING CARDIOVASCULAR IMAGING
APPROPRIATENESS Step 1-Indications and
Literature Review

• Development of clinical indications
• Wide range of applications, including detection
  or exclusion of disease, risk stratification,
  evaluation of therapeutic benefit
• Definition of patient population and specific
  factors
• Attempt to identify common applications
• Derived in part from published guidelines
• Use of outside reviewer
• Standardized literature review
• Guidelines
• Evidence tables
• Key articles

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APPROPRIATENESS CRITERIA FORRADIONUCLIDE
CARDIOVASCULAR IMAGINGClinical Stratification
PRE-TEST PROBABILITY OF CAD 1. Diamond, GA,
Forrester JS NEJM 1979 300 1350-8 2. Adapted
from ACC/AHA Exercise Testing Guidelines Gibbons
et al, 2002 Available www.acc.org.
CORONARY HEART DISEASE RISK 3. Adapted from
Grundy et al, 1999 ACC/AHA Scientific
Statement Assessment of Cardiovascular Risk JACC
34 1348-59 www.nhlbi.nih.gov/about/framingham/ri
skabs.html
PRE-OPERATIVE INDICATIONS 4. ACC/AHA
Perioperative Cardiovascular Evaluation
Guidelines, Eagle KA et al 2002 Circ.
1051257-1267
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METHOD FOR DETERMINING CARDIOVASCULAR IMAGING
APPROPRIATENESS Step 2-Expert Reading Panel

• Panel composition
• Range from 9-15 people
• Varied backgrounds, including imaging
  specialists, referring physicians, health service
  researchers, and payors
• Provided with ACC/AHA Guidelines for each
  indication, when available, as a guide
• Cost implicitly considered
• Independent rating

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METHOD FOR DETERMINING CARDIOVASCULAR IMAGING
APPROPRIATENESS Step 3-Panel Meeting

• Distribution of members scores, as well as
  median value and score distribution
• Goal is not to reach consensus, but to share and
  discuss perspectives and clarity of indication
• Re-evaluation of indication list
• Individual re-rating of indications--may be done
  within several weeks

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METHOD FOR DETERMINGING CARDIOVASCULAR IMAGING
APPROPRIATENESS Step 4-Rating Tabulation

• Arithmetic median score and appropriateness
  category
• Conservative assignment to Uncertain category
• Mean score of 3.5 or 6.5 is Uncertain
• BIOMED Concerted Action of Appropriateness
• If at least 4 panelists score at each extreme,
  indication is deemed Uncertain irrespective of
  mean score

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APPROPRIATENESS OF CARDIOVASCULAR IMAGING RAND
Method with Modified Delphi Process
Expert Panel rates the indications in two rounds
1st Round No interaction 2nd Round Panel
interaction
Appropriateness Determination
Retrospective comparison with clinical records
Prospective clinical decision aids
Validation
Use that is Appropriate, Uncertain,
Inappropriate
Increase Appropriateness
Adapted from Fitch K, et al. The RAND/UCLA
Appropriateness Method Users Manual, 2001, 4
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APPROPRIATENESS CRITERIA USING THE RAND/DELPHI
METHODOLOGYDifferences from ACR Application

• Uses only two rounds of ratings, so as not to
  force consensus or to reduce real differences of
  clinical opinion that may underlie indications
  rates asuncertain
• Extends indications beyond diagnosis, and
  includes risk assessment and evaluation of
  therapy
• Incorporates imaging within the context of
  patient history
• Extension to asymptomatic patients and includes
  consideration of repeat (serial) imaging
• Evaluation of appropriateness of single methods
  for a specific use, not exclusive cross-modality
  comparison

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APPROPRIATENESS CRITERIA FORRADIONUCLIDE
CARDIOVASCULAR IMAGINGMethods

• Selection of 12 Technical Panel members
• First round rating
• Face-to-face meeting
• Review of ratings
• Discussion of indications
• Consensus not mandated
• Second round rating w/i 10 days after meeting
• Compilation of rankings
• Completion of manuscript
• Organizational approval
• Publication and communication

Courtesy of R.Hendel
Brindis RG,et al. JACC 2005461589
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ACCF/ASNC Appropriateness Criteria for SPECT
Myocardial Perfusion Imaging A Report of the
American College of Cardiology Foundation Quality
Strategic Directions Committee Appropriateness
Criteria Working Group and the American Society
of Nuclear Cardiology
APPROPRIATENESS CRITERIA WORKING GROUP Ralph
Brindis, MD, FACC, Chair and Technical Panel
Moderator Robert Hendel, MD, FACC, FAHA,
Technical Panel Co-Moderator Pamela Douglas, MD,
FACC, FAHA Eric Peterson MD, FACC, FAHA
Michael Wolk, MD, FACC Joseph Allen, MA Ira
Raskin, PhD Manesh Patel, MD TECHNICAL
PANEL MEMBERS Timothy Bateman, MD, FACC, FAHA
Manuel Cerqueira, MD, FACC Raymond Gibbons, MD,
FACC, FAHA Linda Gillam, MD, FACC, FAHA John
Gillespie, MD, FACC Robert Hendel, MD, FACC,
FAHA Ami Iskandrian, MD, FACC, FAHA Scott
Jerome, DO, FACC Harlan Krumholz, MD, FACC,
FAHA Joseph Messer, MD, MACC, FAHA John
Spertus, MD, FACC, FAHA Stephen Stowers, MD, FACC
J Am Coll Cardiology 2005 46 1587-605
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APPROPRIATENESS CRITERIA FORRADIONUCLIDE
CARDIOVASCULAR IMAGINGSample Indications

• Evaluation of chest pain syndromes
• Intermediate probability, ECG uninterpretable or
  unable to exercise
• New onset atrial fibrillation
• High risk (Framingham)
• Risk stratification
• Asymptomatic, moderate risk (Framingham)
• Asymptomatic, moderate risk (Framingham), high
  risk occupation
• Patients with prior test results
• Asymptomatic, normal prior SPECT, annual
  re-evaluation
• Known CAD but no revascularization, greater than
  2 yrs since prior study
• Asymptomatic, indeterminate stenosis on CT
  angiography
• Pre-operative evaluation
• Low risk surgery
• High risk surgery, poor exercise tolerance
• Post-revascularization
• Asymptomatic after PCI, symptoms before PCI, lt
  1year
• Asymptomatic after PCI, no symptoms before PCI,
  lt1 year

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APPROPRIATENESS CRITERIA FORRADIONUCLIDE
CARDIOVASCULAR IMAGINGResults of Ratings
Brindis, et al. JACC 2005461589-1590
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APPROPRIATENESS CRITERIA FORRADIONUCLIDE
CARDIOVASCULAR IMAGINGSample Inappropriate
Indications

• Low likelihood of CAD, with interpretable ECG and
  able to exercise
• Chest pain with ST elevation
• Asymptomatic patient with CAClt100
• Pre-operative assessment for low risk surgery
• Asymptomatic, s/p PCI or CABG within 2 years

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CARDIAC CT AND CARDIAC MR

• Newer technologies
• Evolving applications
• Expensive instrumentation
• No clear patient-care algorithms
• Concern regarding potential for uncontrolled
  utilization and stimulation of downstream testing
  and treatment

• CCT potential applications
• Calcium scoring/screening
• Angiography (hard/soft plaque)
• Morphology (including congenital)
• CMR potential applications
• Structure (myocardial, valvular)
• Function
• Viability
• Stress perfusion and function

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ACCF/SCCT/SCMR/ACR/ASNC/NASCI/SCAI/SIR
Appropriateness Criteria for Cardiac Computed
Tomography and Cardiac Magnetic Resonance Imaging

• CCT/CMR WRITING GROUP
• Robert C. Hendel, MD, FACC, FAHA Manesh R.
  Patel, MD
• Christopher M. Kramer, MD, FACC, FAHA Michael
  Poon, MD, FACC
• TECHNICAL PANEL MEMBERS
• Robert C. Hendel, MD, FACC, FAHA, Moderator
• James Carr, MD Joseph Messer, MD
• Nancy Gerstad, MD Rita Redberg, MD
• Linda Gillam, MD Geoffrey Rubin, MD
• John Hodgson, MD John S. Rumsfeld, MD, PhD
• Raymond Kim, MD Allen Taylor, MD
• Christopher M. Kramer, MD Wm. Guy Weigold, MD
• John Lesser, MD Pamela Woodard, MD
• Edward Martin, MD
• ACCF APPROPRIATENESS CRITERIA WORKING GROUP
• Ralph G. Brindis, MD, MPH, FACC, Chair
• Robert C. Hendel, MD, FACC, FAHA, Pamela S.
  Douglas, MD, MACC, FAHA
  Eric D. Peterson MD, FACC, FAHA, Michael J.
  Wolk, MD, MACC,
• Joseph Allen, MA, Manesh R. Patel, MD

Hendel RC et al, JACC 200648 7
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APPROPRIATENESS CRITERIA FOR CCT AND CMR

• Limited data for these emerging technologies
• Uncertain mostly reflect lack of hard data
• Not all categories of LCD and ICD-9 are
  represented within appropriateness criteria.
• Serve as initial guide for responsible use of CCT
  and CMR
• Recognition of real differences in use
• Requirement for very frequent update/revision

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APPROPRIATENESS CRITERIA FOR CARDIAC COMPUTED
TOMOGRAPHY AND CARDIAC
MAGNETIC RESONANCE
Hendel RC et al, JACC 200648 7
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CARDIAC MRSample Appropriate Indications

• Intermediate risk with uninterpretable ECG or
  inability to exercise
• Angiography with stenosis of unclear significance
• Technically limited echocardiogram for
  morphology, function
• Pericardial disease
• Viability

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CARDIAC CTSample Inappropriate Indications

• Coronary calcium scoring
• Asymptomatic, low risk CAD
• Prior calcium score w/i 5 years
• CT angiography
• High pre-test probability of CAD
• Acute chest pain with ST elevation/() enzymes
• Asymptomatic patients at low or moderate CHD risk
• Moderate-severe ischemia on stress test
• Asymptomatic with (-) angiogram lt 2y beforehand
• Asymptomatic with calcium score 400
• Low risk surgery
• Asymptomatic after CABG or PCI

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CARDIAC CTSample Appropriate and Uncertain
Indications

• Appropriate
• Coronary anomalies
• Chest pain, intermediate risk
• Prior equivocal stress test
• Technically limited echo
• Electrophysiology afib ablation, bi-v pacing
• Dissection
• Pulmonary emboli
• Uncertain
• Triple rule-out
• Asymptomatic, high risk
• Chest pain, s/p PCI or s/p CABG

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APPROPRIATENESS CRITERIAThe ACC Cue

• Nuclear cardiology (SPECT)
• October, 2005
• Cardiac CT/CMR
• September, 2006
• Echocardiography
• Fall-Winter, 2006
• Percutaneous coronary intervention
• Spring, 2007
• CV imaging cross modality (efficiency) evaluation
• Revised SPECT Criteria

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HOW NOT TO USE APPROPRIATENESS CRITERIA

• Appropriateness ranking and scores should NOT be
  compared across modalities
• Different panels
• Background information and dialog different
• Inherent variation
• Uncertain indications should NOT be grounds for
  denials/lack of payment
• Appropriateness criteria are NOT substitutes for
  sound clinical judgment and practice experience

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APPROPRIATENESS OF CARDIOVASCULAR IMAGING
Potential Impact of Appropriateness Criteria

• Establishment of partnership among clinicians,
  educators, and payers regarding rationale
  practices in cardiovascular imaging and fair
  reimbursement
• Education of clinicians regarding their practice
  habits
• Emphasis of clinical indications to drive testing
  
• Facilitate reimbursement for appropriate and
  uncertain indications
• Support for requirement of preauthorization or
  denial of reimbursement for inappropriate
  indications
• Improve cost-effectiveness of cardiovascular
  imaging

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APPROPRIATENESS OF CARDIOVASCULAR IMAGING
Potential Concerns Regarding the Appropriateness
Criteria

• Small number of panel members may drive
  consensus score into a particular category
• Abundance of specialized cardiologists
• Problems with indications/clinical vignettes
• Not inclusive
• Too specific
• Misunderstanding (i.e. post-PCI asymptomatic)
• Differences from published guidelines
• Criteria difficult to use
• Does not currently address underutilization

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APPROPRIATENESS CRITERIA EVALUATIONThe
University of Chicago Experience
p lt 0.001 A vs. U,I
Mehta R, Chandra S, Williams KA, Accepted for
Presentation at ASNC 2006
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• SPECT MPI APPROPRIATENESS FORM
• Patient ______________________ Gender
  ??Male ??Female
• Date ____/____/_____ Age _______ (not DOB)
• Ordering MD__________________ MD Type ?PCP
  ?Cardiologist
• Indication
• ?Detection of CAD Chest Pain/Other
• ?Equivocal test (ECG/SPECT/echo/CT/cath) ?Typic
  al (Definite)
• ?Risk stratification ?Atypical (Probable)
• ?After revascularization (lt5 y) ?Non-anginal
• ?Pre-op Surgical risk-low/interm/high ?Asympto
  matic
• Type of surgery___________ ?Worse
  symptoms
• ?Heart failure
• ?Atrial fibrillation/ventricular ectopy Known
  CAD?

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APPROPRIATENESS CRITERIA EVALUATIONFirst Month
of Experience in Clinical Practice

• Acceptable return of forms (92)
• Poor completion rate (56)
• Chest pain
• Surgery type
• Pre-test risk
• Confusion regarding some indications
• Unclear of differences between detection of CAD
  and risk stratification
• Description of chest pain/symptoms
• Lack of data, i.e. CHD risk in elderly

Following revascularization most common
indication (38)
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APPROPRIATENESS OF CARDIOVASCULAR IMAGING
Current Impact

• Education
• Referring physicians
• Laboratories
• Practice performance
• Quality organizations acceptance of methods
• Physician report cards
• Gold Star performers
• Reimbursement
• Payers use for reimbursement algoithms
• Reduction of precertification
• Awareness at federal level

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APPROPRIATENESS OF CARDIOVASCULAR IMAGING Future
Directions-Continuing Evaluation

• Refinement of process
• Validation of ratings
• Consistency with contemporary practice
• Impact of Criteria on test utilization
• Retrospective and prospective reviews
• New research focused on Uncertain indications
• Explicit evaluation of cost
• Revisiting Criteria, with re-rating every 18-24
  months
• Efficiency evaluation for common clinical
  indications

NEED FOR FURTHER RESEARCH
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QUALITY METRICS FOR MEDICAL IMAGING

• Appropriateness

• Structure
• Process (timeliness, pt-centered)
• Reproducibility

• Reproducibility
• Accuracy
• Sensitivity
• Specificity

• Timeliness
• Interpretability
• Clinical integration

Courtesy of J Spertus
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QUALITY GOALS AND ACTION ITEMS IN THE DIMENSIONS
OF CARE FRAMEWORK FOR CARDIOVASCULAR IMAGING
Quality Goals Action Items
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APPROPRIATENESS IN CARDIAC IMAGINGConclusions

• High profile growth of cardiac imaging
• CMS, private payers will likely attempt to
  restrain growth
• Initial steps for quality completed
• Accreditation mandatory
• Certification increasingly required
• Appropriateness criteria in progress
• Implementation, education, and enforcement
• Frequent revisions
• Quality metrics for cardiac imaging are essential
  
• Duke/ACC Conference charge to sub-specialists
• Use of Appropriateness Criteria in daily practice
• Evaluation tools in development
• Movment towards P4P Appropriateness Criteria key
  component