Download What`s Not So Good About the Appropriateness Criteria

Appropriateness Criteria for Coronary Revascularization
The Practice of Medicine is Already Over-Regulated and
these Criteria Reflect Existing Guidelines
Ted Feldman MD, FSCAI FACC FESC
Evanston Hospital
SCAI Annual Fellows Course
Las Vegas
December 5th-8th, 2012
Ted Feldman MD, FACC, FESC, FSCAI
Disclosure Information
The following relationships exist:
Grant support: Abbott, BSC,
Edwards, St Jude, WL Gore
Consultant: Abbott, BSC, Coherex, Edwards, Intervalve,
Diiachi Sankyo-Lilly, WL Gore
Speaker: Boston Scientific
Co-author of the
Off label use 2005-2008
of products and investigational
PCI devices
will be discussed in this presentation
Guideline statements
December 2008
2008
* Atherosclerotic Peripheral Vascular Disease Symposium II
o Executive Summary
o Nomenclature for Vascular Diseases
o Screening for Atherosclerotic Vascular Diseases: Should Nationwide Programs Be Instituted?
o Vascular Magnetic Resonance and Computed Tomographic Imaging
o Stroke Intervention: State of the Art
o Controversies in Carotid Artery Revascularization
o Controversies in Abdominal Aortic Aneurysm Repair
o Lower-Extremity Revascularization: State of the Art
o Intervention for Renal Arterial Disease
* ADA/ACCF/AHA Intensive Glycemic Control and the Prevention of Cardiovascular Events: Implications of the ACCORD, ADVANCE,
and VA Diabetes Trials
* Heart Disease and Stroke Statistics—2009 Update
*
2008 Key Data Elements and Definitions for Cardiac Imaging
*
2008 Health Policy Statement on Structured Reporting in Cardiovascular Imaging
November 2008
June 2009
1st HALF 2009
*Cardiovascular Evaluation and Management of Severely Obese Patients Undergoing Surgery
*Exercise Training for Type 2 Diabetes Mellitus: Impact on Cardiovascular Risk
*Mortality, Health Outcomes, and Body Mass Index in the Overweight Range
*Recommendations for Clinical Exercise Laboratories
May 2009
*
*
*
*
*
ACC/AHA
ACC/AHA
ACC/AHA
ACC/AHA
ACC/AHA
Classification of Care Metrics: Performance Measures and Quality Metrics
2008 Statement on Performance Measurement and Reperfusion Therapy
2008 Performance Measures for Adults With ST-Elevation and Non–ST-Elevation Myocardial Infarction
2008 Guidelines for the Management of Adults With Congenital Heart Disease: Executive Summary
2008 Guidelines for the Management of Adults With Congenital Heart Disease: Full Text
October 2008
* Post–Cardiac Arrest Syndrome: Epidemiology, Pathophysiology, Treatment, and Prognostication
* Standards for Measures Used for Public Reporting of Efficiency in Health Care
* ACCF/ACG/AHA 2008 Expert Consensus Document on Reducing the Gastrointestinal Risks of Antiplatelet Therapy and NSAID Use
September 2008
* 2008 Focused Update Incorporated Into the ACC/AHA 2006 Guidelines for the Management of Patients With Valvular Heart Disease
*Expansion of the Time Window for Treatment of Acute Ischemic Stroke With Intravenous Tissue Plasminogen* Activator
The American Heart Association's 2008 Statement of Principles for Healthcare Reform
* Depression and Coronary Heart Disease: Recommendations for Screening, Referral, and Treatment
*Comprehensive Overview of Nursing and Interdisciplinary Care of the Acute Ischemic Stroke Patient
* ACCF/ASNC/ACR/AHA/ASE/SCCT/SCMR/SNM 2009 Appropriate Use Criteria for Cardiac Radionuclide Imaging
August 2008
* The American Heart Association’s Principles for Comparative Effectiveness Research
*AHA/ASA/ACCF Percutaneous Device Closure of Patent Foramen Ovale for Secondary Stroke Prevention: A Call
for Completion
of
* AHA/ACCF/HRS
Noninvasive
Risk Stratification Techniques for Identifying Patients At Risk for Sudden Cardiac Death
*Implementation and Integration of Prehospital ECGs Into Systems of Care for Acute Coronary Syndrome
Randomized Clinical Trials
*Ambulatory Blood Pressure Monitoring in Children and Adolescents: Recommendations for Standard Assessment
*Recommendations for the Implementation of Telemedicine Within Stroke Systems of Care
*A Review of the Evidence for the Use of Telemedicine Within Stroke Systems of Care
July 2008
*Definition and Evaluation of Transient Ischemic Attack
April 2009
*Criteria for Evaluation of Novel Markers of Cardiovascular Risk
*Indications for the Performance of Intracranial Endovascular Neurointerventional Procedures
March 2009
* AHA/ACCF Sleep Apnea and Cardiovascular Disease
* ACC/AHA 2008 Guideline Update on Valvular Heart Disease: Focused Update on Infective Endocarditis
* Management of Stroke in Infants and Children
* Translating Research Into Practice for Healthcare Providers: The American Heart Association’s Strategy for Building Healthier Lives,
Free of Cardiovascular Diseases and Stroke
* The Impact of Prevention on Reducing the Burden of Cardiovascular Disease
June 2008
* Population-Based Prevention of Obesity: The Need for Comprehensive Promotion of Healthful Eating, Physical Activity, and Energy
Balance
* Childhood Obesity Research Summit Report
* Noninvasive Coronary Artery Imaging: Magnetic Resonance Angiography and Multidetector Computed Tomography Angiography
* Childhood Obesity Research Summit: Executive Summary
* State of the Science Conference: Initiative to Decrease Cardiovascular Risk and Increase Quality of Care for Patients Living With
* ACCF/AHA 2009 Expert Consensus Document on Pulmonary Hypertension
HIV/AIDS: Executive Summary
* 2009 Focused Update: ACCF/AHA Guidelines for the Diagnosis and Management of Heart Failure in Adults * Contribution of Metabolic and Anthropometric Abnormalities to Cardiovascular Disease Risk Factors
Epidemiological
Evidence for Cardiovascular Disease in HIV-Infected Patients and Relationship to Highly Active Antiretroviral
* 2009 Focused Update Incorporated Into the ACC/AHA 2005 Guidelines for the Diagnosis and Management of*Heart
Failure in
Therapy
Adults
* Effects of HIV Infection and Antiretroviral Therapy on the Heart and Vasculature
* Implementing American Heart Association Pediatric and Adult Nutrition Guidelines
* Screening and Assessment of Coronary Heart Disease in HIV-Infected Patients
February 2009
* Prevention of Rheumatic Fever and Diagnosis and Treatment of Acute Streptococcal Pharyngitis
* AHA/ACCF/HRS Recommendations for the Standardization and Interpretation of the Electrocardiogram
o Part III: Intraventricular Conduction Disturbances
o Part IV: The ST Segment, T and U Waves, and the QT Interval
o Part V: Electrocardiogram Changes Associated With Cardiac Chamber Hypertrophy
o Part VI: Acute Ischemia/Infarction
* Ionizing Radiation in Cardiac Imaging
January 2009
*
*
*
*
*
Omega-6 Fatty Acids and Risk for Cardiovascular Disease
Guidelines for the Management of Aneurysmal Subarachnoid Hemorrhage
Progress and Challenges in Metabolic Syndrome in Children and Adolescents
ACCF/SCAI/STS/AATS/AHA/ASNC 2009 Appropriateness Criteria for Coronary Revascularization
Partnering to Reduce Risks and Improve Cardiovascular Outcomes
*
*
*
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Development of Appropriate Coronary Heart Disease Risk Prediction Models in HIV-Infected Patients
Prevention Strategies for Cardiovascular Disease in HIV-Infected Patients
Wallet Card, ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities
ACC/AHA Pocket Guideline Based on the ACC/AHA/HRS 2008 Guidelines "Device-Based Therapy of Cardiac Rhythm Abnormalities"
May 2008
*
*
*
*
Call to Action on Use and Reimbursement for Home Blood Pressure Monitoring: Executive Summary
Call to Action on Use and Reimbursement for Home Blood Pressure Monitoring: Full Text
ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities: Executive Summary
ACC/AHA/HRS 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities: Full Text
April 2008
* Cardiovascular Monitoring of Children and Adolescents With Heart Disease Receiving Medications for Attention Deficit/Hyperactivity
Disorder
* Essential Features of Designating Out-of-Hospital Cardiac Arrest as a Reportable Event
* Resistant Hypertension: Diagnosis, Evaluation, and Treatment
* Prevention of Heart Failure
March 2008
* Hands-Only (Compression-Only) Cardiopulmonary Resuscitation: A Call to Action for Bystander Response to Adults Who Experience
Out-of-Hospital Sudden Cardiac Arrest
* Management of Cocaine-Associated Chest Pain and Myocardial Infarction
* Percutaneous and Minimally Invasive Valve Procedures
* Update to the AHA/ASA Recommendations for the Prevention of Stroke in Patients With Stroke and Transient Ischemic Attack
* ACCF/ASE/ACEP/AHA/ASNC/SCAI/SCCT/SCMR 2008 Appropriateness Criteria for Stress Echocardiography
February 2008
* Hyperglycemia and Acute Coronary Syndrome
* ACC/AHA/Physician Consortium 2008 Clinical Performance Measures for Adults With Nonvalvular Atrial Fibrillation or Atrial Flutter
January 2008
* Reducing Barriers for Implementation of Bystander-Initiated Cardiopulmonary Resuscitation
Scientific Evidence Underlying the ACC/AHA
Clinical Practice Guidelines
Level of Evidence A in only 12%
 Study Question: What is the evolution of recommendations in
ACC/AHA cardiovascular guidelines and the distribution of
recommendations in relationship to the levels of evidence?
 Methods: Fifty-three guidelines on 22 topics, including a total
of 7,196 recommendations, were abstracted.
Quantity, yes!!
The proportion
of recommendations
forso
whichmuch….
there is no
Quality,
not
conclusive evidence is also growing.
 Conclusions: Recommendations in current ACC/AHA practice
guidelines are largely developed from lower levels of evidence
or expert opinion.
•
 These findings highlight the need to improve the process of
writing guidelines and to expand the evidence base from which
clinical practice guidelines are derived.
Tricoci P, Allen JM, Kramer JM, Califf RM, Smith CS Jr.
JAMA 2009;301:831-841
Disclaimer?
 First, PCI is a technique that has been continually refined
and modified; hence, continued, periodic guideline
revision is anticipated.
 Second, these guidelines are to be viewed as broad
recommendations to aid in the appropriate application of
PCI. Under unique circumstances, exceptions may exist.
• The ultimate judgment regarding care of a particular patient must
be made by the healthcare provider and patient in light of all of
the circumstances presented by that patient.
 These guidelines are intended to complement, not
replace, sound medical judgment and knowledge.
Use
Judgement
Follow
Guidelines
What is the Gold Standard??
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





Guidelines
Performance measures
Appropriateness criteria
Standard of practice in the community
FDA labeling
CMS reimbursement
Private insurance coverage policy
ACCF/SCAI/STS/AATS/AHA/ASNC
2009 Appropriateness Criteria for
Coronary Revascularization
Manesh, R.P. et al. J. Am. Coll. Cardiol. published online Jan 5, 2009
The Role of Appropriate Use Criteria for Coronary
Revascularization
 AUC are developed to determine whether a particular approach
to care is reasonable in a given clinical scenario. This is partly in
response to a growing concern from payers and patients
regarding the potential overuse or misuse of advanced
technologies for cardiovascular care.
 In some areas of practice guidelines, the level of evidence is
reduced to group consensus due to the lack of “hard” data from
randomized controlled trials. The same holds true for cardiac
catheterization and coronary revascularization when one tries to
extrapolate and apply study findings to real world scenarios. For
this reason, there is substantial variation in the application of
these procedures.
2009;53;554-555 J. Am. Coll. Cardiol.
W. Douglas Weaver, Timothy J. Gardner, and Joseph D. Babb
Unlike prevention and treatment
strategies supported by evidence-based
practice guidelines, the evidence base
for imaging is anecdotal, fragmented,
and lacking in prospective clinical trials.
Appropriateness Criteria
for Coronary Revascularization
 scored on a scale of 1 to 9
• Scores of 7 to 9 indicate that revascularization was
considered appropriate and likely to improve health
outcomes or survival
• Scores of 1 to 3 indicate revascularization was
considered inappropriate and unlikely to improve health
outcomes or survival
• Mid range (4 to 6) indicates likelihood that coronary
revascularization would improve health outcomes or
survival was considered uncertain.
 17-member technical panel
• 4 interventional cardiologists, 4 CVr surgeons, 8 cardiologists,
others who treat patients with cardiovascular disease, health
outcome researchers, and 1 medical officer from a health plan
underuse was common (57% according to panel A
and 71.3% according to panel B), and not
undergoing coronary angiography was associated
with higher coronary event rates than was
undergoing the procedure.
Ko DT J Am Coll Cardiol 2012
Cardiac Care Network Ontario Variations in Revascularization Practice in Ontario Working Group
Guidelines simplified??
Appropriateness Criteria
for Coronary Revascularization
Manesh, R.P. et al. J. Am. Coll. Cardiol. published online Jan 5, 2009
The Megapixel Myth
8.1 Megapixel Digital Camera
 For normal 4x6 prints, even VGA is just fine. Digital
cameras did this back in 1991!
 Sharpness depends more on your photographic skill
than the number of megapixels
 Sharpness has little to do with image quality, and
resolution has little to do with sharpness. Resolution
(pixel count) has nothing to do with picture quality.
Color and tone are far more important technically.
 The megapixel myth was started by camera makers and
swallowed hook, line and sinker by camera measurebators. Camera makers use the number of megapixels a
camera has to hoodwink you into thinking it has
something to do with camera quality.
However, it is critical for
everyone and especially
payers to understand that
the AUC were never
intended to be the final
answer in determining
payment for procedures
ACC/AHA 2013 Guidelines for the
Management of Guidelines
Guidelines
Gregory J. Dehmer, MD FACC FSCAI, Gregory J. Dehmer, MD FACC FSCAI
Gregory J. Dehmer, MD FACC FSCAI, Gregory J. Dehmer, MD FACC FSCAI, Gregory J.
Dehmer, MD FACC FSCAI, Gregory J. Dehmer, MD FACC FSCAI, Gregory J. Dehmer, MD
FACC FSCAI, Gregory J. Dehmer, MD FACC FSCAI, Gregory J. Dehmer, MD FACC FSCAI,
Gregory J. Dehmer, MD FACC FSCAI, Gregory J. Dehmer, MD FACC FSCAI, Gregory J.
Dehmer, MD FACC FSCAI, Gregory J. Dehmer, MD FACC FSCAI, Gregory J. Dehmer, MD
FACC FSCAI
TASK FORCE MEMBERS
Gregory J. Dehmer, MD FACC FSCAI, Gregory J. Dehmer, MD FACC FSCAI
Gregory J. Dehmer, MD FACC FSCAI, Gregory J. Dehmer, MD FACC FSCAI, Gregory J.
Dehmer, MD FACC FSCAI, Gregory J. Dehmer, MD FACC FSCAI, Gregory J. Dehmer, MD
FACC FSCAI, Gregory J. Dehmer, MD FACC FSCAI, Gregory J. Dehmer, MD FACC FSCAI,
Gregory J. Dehmer, MD FACC FSCAI, Gregory J. Dehmer, MD FACC FSCAI, Gregory J.
Dehmer, MD FACC FSCAI, Gregory J. Dehmer, MD FACC FSCAI, Gregory J. Dehmer, MD
FACC FSCAI, Gregory J. Dehmer, MD FACC FSCAI, Gregory J. Dehmer, MD FACC FSCAI,
Gregory J. Dehmer, MD FACC FSCAI, Gregory J. Dehmer, MD FACC FSCAI
GUIDELINE
S
Practice simplified??