Transcript Risk Stratification of Coronary Artery Disease with

Current Status of Evidence Appraisal in
Appropriateness Criteria Development
AHA
QCOR Conference
Washington, DC
May 20,2010
Ralph Brindis, MD MPH FACC
President, American College of Cardiology
Senior Advisor for CV Disease,
Northern California Kaiser Permanente
Clinical Professor of Medicine, UCSF
Presenter Disclosure Information
• Ralph Brindis, MD MPH FACC FSCAI
• “Current Status of Evidence Appraisal in
Appropriateness Criteria Development”
•
FINANCIAL DISCLOSURE:
NONE
UNLABELED/UNAPPROVED USES DISCLOSURE:
NONE
Institute of Medicine
Priorities for America
•
We must Appropriate
overhaul the system
!!! to create
care to ensure it is:
Safe, Timely, Equitable, Efficient,
Evidence-based and Patient-centered
•
Care should…
•
Be customized to patients’ needs and values
•
Have the patient be the source of control
•
Enable knowledge to be shared freely
Institute of Medicine, Crossing the Quality Chasm:
A New Health System for the Twenty-first Century
Adams, K & Corrigan,JM. Priority Areas for National Action:
Transforming Health Care Quality, IOM 2003
Variation in the Use of PCI vs. CABG
US average is 2.6
PCIs for each CABG
February 4, 2009
http://www.dartmouthatlas.org/
Variation in PCI Higher than Other Procedures
3.0
Variation in procedures per 1000 Medicare
patients in 306 hospital referral regions
1.0
0.3
Colectomy
for CA
Source: Dartmouth Atlas
CABG
TURP
Hip
Replacement
Back
Surgery
PCI
Potential Impact of
Inappropriate PCI
Inappropriate PCI
• 900,000 PCI/yr in US
• 6% inappropriate and 38% uncertain (NY/Rand)
• 0-25% of uncertain PCI are actually inappropriate
~700 - 1700 deaths avoidable by eliminating Inappropriate PCI
What are
Appropriateness Criteria?
• Define “what to do”, “when to do”, and “how often to do” in the
context of local care environments combined with patient and
family preferences and values
• Address misuse, overuse and underuse
• Connected to guideline content
• Imply a level of detail and complexity that extends beyond the
current recommendations
Guidelines and AUC
• Clinical Practice Guidelines (State of Science)
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•
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Exhaustive review of literature
Virtually all-inclusive
Best practice
“Should do, should not do”
Class I, Class III, Class IIa, IIb
• Appropriate Use Criteria - AUC
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Selective indications
Largely guideline based
Clinical scenarios/frequency
“Reasonable to do”
Used to evaluate practice patterns
Development of CPG’s, Performance Measures, and
Appropriate Use Documents
Circulation
2009:119:1180-1185.
Antman & Peterson,Antman,
Circulation
2009:119:1180-1185.
APPROPRIATE USE CRITERIA
The ACC Queue
COMPLETED
√ Nuclear cardiology (SPECT)
October, 2005
√ Cardiac CT/CMR
September, 2006
√ Echocardiography (TTE, TEE)
July, 2007
√ Echocardiography (Stress)
IN PROGRESS
• Multi-modality criteria (with ACR)
–Heart failure
–Acute chest pain
• Revised CT criteria (completed)
• Revised echocardiography criteria
• Peripheral vascular disease
December, 2007
 Coronary revascularization
December, 2008
 Revised radionuclide imaging
May, 2009
• Diagnostic catheterization
Appropriateness Use Criteria Developed Using a
Modified Rand/Delphi Methodology
The Writing
Committee
What are the known indications
for coronary revascularization?
- Major randomized trials
- Guidelines
- Other sources
Define “Appropriateness”
for Coronary Revascularization
Extensive CPG & literature
review and synthesis
of the evidence (usually after
clinical scenarios created)
Developing the Appropriateness Use Criteria
Define “Appropriateness”
for Coronary Revascularization
The Writing
Committee
What are the known indications
for coronary revascularization?
- Major randomized trials
- Guidelines
- Other sources
Assumptions and
Definitions
CPG and literature review and synthesis
of the evidence (pre and/or post clinical
scenario creation)
 70% stenosis significant (>50% for LM)
Maximum medical therapy
(use of  2 drug classes)
High, Intermediate, low-risk stress tests
High-risk clinical features
(ECG, biomarkers, exam findings)
Domains for Clinical Decision Making
Five Core Variables
Stable
angina
Class I
ASx
None
Low risk
None
LM +
3v CAD
ANATOMY
Max
MEDICAL Rx
High
risk
ISCHEMIA TESTING
Class IV
SYMPTOMS
STABILITY
STEMI
No sig.
CAD
Over
4000
Possible
Clinical
Scenarios
180
Clinical
Scenarios
Developing the Appropriateness Use Criteria
The Writing
Committee
• The Technical Panel
– Nominated by professional societies
– Selected for balance by the writing
committee and Task Force
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4 interventional cardiologists
4 CT surgeons
8 cardiologists
1 Health plan officer
Define “appropriateness”
Preliminary CPG & literature search
Assumptions & definitions
Developed 180 clinical scenarios
Scenarios critiqued by
all organizations
Scenarios modified and improved
& In-depth literature, CPG search
Most examine the
“appropriateness” of
revascularization
Scored by a Technical Panel
4 interventional cardiologists; 4 CT surgeons; 8 cardiologists; 1 Health plan officer
Number 17
Stable patients without prior CABG
CCS Angina Class
ASx
I or
II
Appropriateness Score
(7-9) Appropriate
(4-6) Possibly Appropriate/Uncertain
(1-3) Inappropriate
MODIFIED RAND DELPHI METHODOLOGY
Independent 1st round ratings
Ratings tabulated – agreement determined
Face-to-face meeting – ratings discussed
Independent 2nd and final round ratings
III or
IV
Framework for Decision Making
Stable
angina
Class I
ASx
Max
None
Low risk
None
LM +
3v CAD
ANATOMY
High
risk
MEDICAL Rx
Class IV
SYMPTOMS
STABILITY
STEMI
ISCHEMIA
Five Core Variables
No sig.
CAD
A
U
I
Low-Risk Findings on Non-invasive Imaging Study
And Asymptomatic
(Patients Without Prior Bypass Surgery)
Non-invasive testing
Symptoms/Rx
Burden of disease
AUC Methods are Robust, Thoughtful
& Evidence Based
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Unprecedented Transparency: Appendices
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AUC Scores; Evidence tables & Maps to CPGs
AUC Coronary Revascularization:
• 100% Congruence for CPG’s Class I & III Recs
Cost is implicitly considered
Successfully Identifies new areas for research
Mapping of AUC with CPGs
6. 
A(8) 
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STEMI with presumed successful treatment with fibrinolysis
Asymptomatic; no HF, no recurrent ischemic symptoms, or no unstable
ventricular arrhythmias at time of presentation
Depressed LVEF
Three vessel coronary artery disease
Elective/semi-elective revascularization
STEMI (p. e65)
Percutaneous Coronary Intervention After Fibrinolysis
Class IIa
It is reasonable to perform routine PCI in patients with LVEF less than or equal to 0.40, CHF, or serious ventricular arrhythmias. (Level of Evidence:
C)
PCI (p. e53)
PCI After Successful Fibrinolysis or for Patients Not Undergoing Primary Reperfusion
Class IIa
It is reasonable to perform routine PCI in patients with LV ejection fraction less than or equal to 0.40, HF, or serious
ventricular arrhythmias. (Level of Evidence: C)
CABG (p. e281)
ST-Segment Elevation MI (STEMI)
Class IIa
In patients who have had an STEMI or NSTEMI, CABG mortality is elevated for the first 3 to 7 days after infarction, and the
benefit of revascularization must be balanced against this increased risk. Beyond 7 days after infarction, the criteria for
revascularization described in previous sections are applicable. (Level of Evidence: B)
Mapping of AUC with CPGs
13.
Asymptomatic:
I2
I or II: U5
III or IV: A7
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One or two vessel coronary artery disease without involvement
of proximal LAD
Low-risk findings on non-invasive testing
Receiving a course of maximal anti-ischemic medical Rx
Chronic Stable Angina (p. 77-78)
Recommendations for Revascularization With PCI (or Other Catheter-Based Techniques) and CABG in
Patients With Stable Angina
Class I
Coronary artery bypass grafting for patients with one- or two-vessel CAD without significant proximal LAD CAD who have
survived sudden cardiac death or sustained ventricular tachycardia. (Level of Evidence: C)
Class III
Use of PCI or CABG for patients with one- or two vessel CAD without significant proximal LAD CAD, who have mild symptoms
that are unlikely due to myocardial ischemia, or who have not received an adequate trial of medical therapy and
a. have only a small area of viable myocardium or
b. have no demonstrable ischemia on noninvasive testing. (Level of Evidence: C)
Chronic Stable Angina (p. 90-91)
Recommendations for Revascularization with PCI and CABG in Asymptomatic Patients
Class III
Use of PCI or CABG for patients with one- or two-vessel CAD without significant proximal LAD CAD and
a.only a small area of viable myocardium or
b.no demonstrable ischemia on noninvasive testing. (Level of Evidence: C)
Use of PCI or CABG for patients with borderline coronary stenoses (50% to 60% diameter in locations other than the left main
coronary artery) and no demonstrable ischemia on noninvasive testing. (Level of Evidence: C)
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Continued: Asymptomatic: I2; I or II: U5; III or IV: A7
One or two vessel coronary artery disease without involvement of proximal LAD
Low-risk findings on non-invasive testing
Receiving a course of maximal anti-ischemic medical Rx
CABG (p. e 279)
Asymptomatic or Mild Angina
Class IIb
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CABG may be considered for patients with asymptomatic or mild angina who have 1- or 2vessel disease not involving the proximal LAD (If a large area of viable myocardium and highrisk criteria are met on noninvasive testing, this recommendation becomes (Class I)Evidence:B
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CABG (p. e280)
Stable Angina
Class I
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CABG is beneficial for patients with stable angina who have developed disabling angina
despite maximal noninvasive therapy, when surgery can be performed with acceptable risk. If
angina is not typical, objective evidence of ischemia should be obtained. (Level of Evidence: B)
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Class III
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CABG is not recommended for patients with stable angina who have 1- or 2-vessel disease
not involving significant proximal LAD stenosis, patients who have mild symptoms that are
unlikely due to myocardial ischemia, or patients who have not received an adequate trial of
medical therapy and
a. have only a small area of viable myocardium or (Level of Evidence: B)
b. have no demonstrable ischemia on noninvasive testing. (Level of Evidence: B)
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Continued: Asymptomatic: I2; I or II: U5; III or IV: A7
One or two vessel coronary artery disease without involvement of proximal LAD
Low-risk findings on non-invasive testing
Receiving a course of maximal anti-ischemic medical Rx
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PCI (p. e40)
Patients With Asymptomatic Ischemia or CCS Class I or II Angina
Class III
PCI is not recommended in patients with asymptomatic ischemia or CCS class I or II angina who do not meet
the criteria as listed under the class II recommendations or who have 1 or more of the following:
a. Only a small area of viable myocardium at risk
b. No objective evidence of ischemia.
c. Lesions that have a low likelihood of successful dilatation.
d. Mild symptoms that are unlikely to be due to myocardial ischemia.
e. Factors associated with increased risk of morbidity or mortality.
f. Left main disease and eligibility for CABG.
g. Insignificant disease (less than 50% coronary stenosis). (Level of Evidence: C)
Stable Ischemic Heart Disease
Recommendations for Revascularization with CABG to Improve Survival in Patients with
Stable Ischemic Heart Disease
Class IIa
Embargoed
Class III
Embargoed
Continued: Asymptomatic: I2; I or II: U5; III or IV: A7
One or two vessel coronary artery disease without involvement of proximal LAD
Low-risk findings on non-invasive testing
Receiving a course of maximal anti-ischemic medical Rx
Recommendations for Revascularization with PCI to Improve Survival in Patients with
Stable Ischemic Heart Disease
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Class IIa
Embargoed
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Class III
Embargoed
Recommendations for Revascularization with CABG or PCI to Improve Symptoms in
Patients with Stable Ischemic Heart Disease
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Class IIa
Embargoed
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Class Ib
Embargoed
Lessons with AUC-CPG Mapping
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Identification of “Holes” in Evidence Base possibly
not acknowledged in CPGs WGs
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Highlights opportunities of potential focus for
future studies or clinical trials to fill Evidence Gaps
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Opportunities for “cross-talk” with WGs of AUCs,
CPGs, Consensus Documents, Scientific
Advisories, Performance Measures, and NCDR
already occurring!
What Do We Do When There is No Evidence?
Research!!
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SPECT AUC: New Onset Atrial Fibrillation
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Low CAD risk: U
High CAD: A
SPECT CPG: No comment !!
Percentage of High-Risk
SSS by Clinical Risk Groups
Summed Stress Score Results
in Patients W and Wo Atrial Fibrillation
JACC 2007 50:1080
What Does Evidence-Based Mean?
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Methodology Manual for ACCF/AHA Guideline Writing
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Level of Evidence C: Consensus opinion of experts, case studies,
or standard of care.
‘Despite all the evidence that may be available for writing the
guideline, expert interpretation is always necessary. Unfortunately,
much of the evidence falls into the “gray zone” of uncertainty.’
IOM 2001: Evidence based practice is the integration of best
research evidence with clinical expertise and patient values
Even so, must guard against over-reaching:
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Echo GL Class III: Routine screening echo for participation in
competitive sports in pts with a normal cardiovascular exam
Echo AUC: No comment
AMA Physician Consortium for
Performance Improvement (PCPI)
Evidence Required for Measures Development
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PCPI considers all types of evidence reviewed in
guidelines, including expert opinion.
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Additional conditions must be met for acceptance of
guidelines with recommendations based on expert
opinion (e.g., use of a formal consensus
development process).
PCPI Conditions for Acceptance of
Recommendations Based on Consensus Opinion
Recommendation Statements
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Strength of Recommendation rated – HIGH PRIORITY (H.P.)
Methods used for grading strength of Rec. described - H.P.
Consensus Development Process
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Consensus Development Process Described- REQUIRED
Formal Consensus Method Used – REQUIRED
Informal Consensus Method Used – NOT ACCEPTABLE
Potential Benefits and Harms
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Anticipated benefits and potential risks associated with
recommendations described. Benefits must > risk – H.P.
Reproducibility of Appropriateness
Ratings in Cardiovascular Imaging
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2 Independent Panels (15 multi-speciality physicians)
• Stress Echo Panel and TTE/TEE panel
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Rated the same 19 clinical indications
• (Mixture of Stress and TTE/TEE)
• 8 (42%) Inappropriate, 9 (47%) Appropriate,
2 (11%) Uncertain
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Agreement between panels for overall
appropriateness group (A,I,U) was 100%
Patel QCOR 2008
GL and AUC Have Limitations
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Shared by GL and AUC (Antman Circ 2009 119:1180)
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Insufficient evidence base; Not yet ‘living’ documents
Incomplete translation to practice
Untapped potential to improve care
Weak methods to measure consistent use
Neither can cover all clinical scenarios
Practice Guidelines have additional limitations
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Explicitly exclude costs, cost effectiveness
Real risk of ‘academic vacuum’- Unrealistic, unmanageable in our
current health care environment
AUC and CPG Interplay
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Imaging AUC Writing Groups has led to increased
interest in the role & value of Framingham Risk Score
and also the new CV Risk Guidelines publication for AUC
ratings of imaging testing.
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Leape describes Guideline adherence poorer when
changing practice patterns “ahead” of the CPG revisions.
True also with AUC.
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To remain useful and credible, Guidelines and AUC
documents need frequent revision when practice is
advancing. Annual revisions may be needed.
AUC Implementation and Evaluation :
What Have We Learned So Far
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Retrospective and prospective reviews
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>20 abstracts published; 2 peer-reviewed publications
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Average inappropriate rates prior to intervention 10% 20%
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Preliminary studies of tools and education reduce by
50% or more inappropriate use
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Refinement of process; validation of ratings
Challenges with
Appropriateness Use Ratings
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Rely on collection of currently unavailable clinical data to map
patients to appropriateness ratings
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Can the data always be collected?
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Can patients be mapped to the prototypical scenarios?
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SPECT MPI pilot project suggests yes with ideas to make data
collection easier and quicker!!
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Still being validated - AUC implementation will provide pragmatic,
observational research opportunities to study outcomes in specific
populations
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No data yet demonstrating equal, improved, or worse outcomes with
AUC implementation
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Potential of CER (PCORI) for increasing evidence base
Noninvasive Testing
Stress or Imaging Studies Performed5100 : O No
O Yes →If Yes, Specify Test Performed:
Test
Performed
No
Yes
Standard Exercise
Stress Test: (w/o imaging)
O
O
→If Yes,
O Negative
O Positive
O Indeterminant O Unavailable
→If Positive,
O Low O Intermediate
O High O Unavailable
Stress
Echocardiogram
O
O
→ If Yes,
O Negative
O Positive
O Indeterminant O Unavailable
→ If Positive,
O Low O Intermediate
O High O Unavailable
Stress Testing
w/SPECT MPI
O
O
→If Yes,
O Negative
O Positive
O Indeterminant O Unavailable
→If Positive,
O Low O Intermediate
O High O Unavailable
Stress Testing
w/CMR
O
O
→If Yes,
O Negative
O Positive
O Indeterminant O Unavailable
→ If Positive,
O Low O Intermediate
O High O Unavailable
Cardiac CTA
O
O
→If Yes,
O No disease
O 1VD
O 2VD
O Indeterminant O Unavailable
Coronary Calcium
Score
O
O
→ If Yes,
Calcium Score:5251____________
Risk/Extent
Of Ischemia
Result
O 3VD
AUC: Implementation & Evaluation
New Technology
ACC Cardiovascular Imaging Solution
• Migration towards point-of-order
• Embedded clinical decision support
• Tracking/data registry
• Reporting/feedback
“The right objective for health
care is to increase value for
patients, which is the quality of
patient outcomes relative to the
dollars expended.”
- Michael Porter