Appropriate Use Criteria are Inappropriately Used Jeffrey W. Moses, MD

Disclosure Statement of Financial Interest Consulting Fees/Honoraria Consulting Fees/Honoraria BSC,Cordis BSC,Cordis Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Affiliation/Financial RelationshipCompany

Symptoms Med. Rx Class llI or lV Max Rx UAAAA Class I or lI Max Rx UUAAA Asympto- matic Max Rx IIUUU Class llI or lV No/min Rx IUAAA Class I or lI No/min Rx IIUUU Asympto- matic No/min Rx IIUUU Coronary Anatomy CTO of 1 vz. no other disease 1-2 vz. disease no prox. LAD 1 vz. disease of prox. LAD 2 vz. disease with prox. LAD 3 vz. disease no Left Main Low-Risk Findings on Non-invasive Study Patel et al JACC (February): Asymptomatic Stress Test Med. Rx High Risk Max Rx UAAAA High Risk No/min Rx UUAAA Int. Risk Max Rx UUUUA Int. Risk No/min Rx IIUUA Low Risk Max Rx IIUUU Low Risk No/min Rx IIUUU Coronary Anatomy CTO of 1 vz. no other disease 1-2 vz. disease no prox. LAD 1 vz. disease of prox. LAD 2 vz. disease with prox. LAD 3 vz. disease no Left Main Appropriateness Ratings by Low-Risk Findings on Noninvasive Imaging Study and Asymptomatic

CHD Mortality Annual Reviews Ford ES, Capewell S Annual Rev. public Health 32:5-22 ICD-7 (420) ICD-8 ( ) ICD-9 ( ) ICD-10 ( ) Per 100,000 population

US Revascularization Rates Epstein et al, JAMA 201;306:1769 From the beginning of the decade to 2008 – PCI is Down …and still fallling!

Appropriateness of PCI Procedures in the US Chan et al, Appropriateness of Percutaneous Coronary Intervention JAMA 2011;306:53–61 PCI indication ‘Appropriate’‘Uncertain’‘Inappropriate’Total ACS350,469 (98.6%) 1,055 (0.3%)3,893 (1.1%)355,417 Non-ACS72,911 (50.4%) 54,988 (38.0%) 16,838 (11.6%)144,737 Total423,380 (84.6%) 56,043 (11.2%) 20,731 (4.1%) 500,154 Abbreviations: ACS, acute coronary syndrome; PCI, percutaneous coronary intervention.

What is the Evidence of Overuse? CHD Mortality is dropping even today Overall revascularization rates are dropping PCI rates are dropping “Inappropriate” use is less than 5% (for all we know this is too low!)

Results: Of 500,154 PCIs, 71.1% were for acute indications, and 28.9% were for nonacute indications. For acute indications, 98.6% were classified as appropriate, 0.3% uncertain and 1.1% as inappropriate. For nonacute indicaties 50.4% were classified as appropriate, 38.0% as uncertain, and 11.6% as inappropriate.

Evidence Based Medicine? 100,000 unnecessary PCIs for OAT like patients performed each year Judith Hochman, MD Newsweek 8/17/11 (paraphrased ) NCDR AUC review: 1.1% of 355,417 urgent PCIs performed in “OAT” like patients (using 12 hours!)

Accounted for 57.9% of “I” Accounted for 24.5% of “I” Inappropriate or Uncertain?

What is Appropriate? 60-year-old, CCS I, stress EXT–9 min. Small area inferior ischemia, no AA Meds EF 65% Medical Therapy? FFR? Stent? Medical Therapy? FFR? Stent?

Cumulative incidence (%) Registry PCI+MT MT No. at risk FAME 2: Primary Outcomes MT vs. Registry: HR 4.32 ( ); p<0.001 PCI+MT vs. Registry:HR 1.29 ( ); p=0.61 PCI+MT vs. MT: HR 0.32 ( ); p<0.001 Months after randomization De Bruyne B et al. NEJM 2012:on-line

Cumulative incidence (%) 0 7days Months after randomization p-interaction: p=0.003 >8 days: HR 0.42 ( ); p=0.053 ≤7 days: HR 7.99 ( ); p=0.038 MT alone PCI plus MT MT alone PCI plus MT ≤7 days >8 days FAME 2: Kaplan-Meier Plots of Landmark Analysis of Death or MI Cumulative incidence (%) Days after randomization

Assume PCI >12 hours in STEMI is Severe non-LAD lesions are Chan calculation becomes 2,500 inappropriate or U 0.5%!!! U

Before AUC publication, 85 cardiologists from 10 U.S. institutions assessed the appropriateness of coronary revascularization for 68 indications that had been evaluated by the AUC Technical Panel.

Copyright ©2011 American College of Cardiology Foundation. Restrictions may apply. Chan, P. S. et al. J Am Coll Cardiol 2011;57: Red X = median rating of Appropriate Use Criteria Technical Panel; yellow dot = median rating of the physician group; blue bar = interquartile range for the physician group's ratings; size of the circles = weighted distribution of ratings by the physician group. Appropriateness Ratings by the Physician Group for 10 Inappropriate Indications

Concordance of Physician Ratings With the Appropriate Use Criteria for Coronary Revascularization “We found there was excellent concordance (94%) between the 2 groups for clinical indications categorized as appropriate but only modest concordance (70%) for clinical indications categorized as inappropriate. However, there was wide variation (i.e., nonagreement) in ratings of appropriateness among physicians, with more than 25% of physicians assigning an appropriateness category different than the group as a whole in 2 of every 3 scenarios. Moreover, there was substantial variation in appropriateness category assignments between individual physicians and the AUC Technical Panel, with some physicians almost never agreeing with the AUC Technical Panel and no physician achieving more than 80% agreement.” Paul S. Chan, MD, MSc J Am Coll Cardiol, 2011; 57:

Simple Logic If there is no systematic overuse and procedures are dropping then there must be systematic under treatment

Symptoms Med. Rx Class llI or lV Max Rx UAAAA Class I or lI Max Rx UUAAA Asympto- matic Max Rx IIUUU Class llI or lV No/min Rx IUAAA Class I or lI No/min Rx IIUUU Asympto- matic No/min Rx IIUUU Coronary Anatomy CTO of 1 vz. no other disease 1-2 vz. disease no prox. LAD 1 vz. disease of prox. LAD 2 vz. disease with prox. LAD 3 vz. disease no Left Main Low-Risk Findings on Non-invasive Study Patel et al JACC (February): Asymptomatic Stress Test Med. Rx High Risk Max Rx UAAAA High Risk No/min Rx UUAAA Int. Risk Max Rx UUUUA Int. Risk No/min Rx IIUUA Low Risk Max Rx IIUUU Low Risk No/min Rx IIUUU Coronary Anatomy CTO of 1 vz. no other disease 1-2 vz. disease no prox. LAD 1 vz. disease of prox. LAD 2 vz. disease with prox. LAD 3 vz. disease no Left Main Appropriateness Ratings by Low-Risk Findings on Noninvasive Imaging Study and Asymptomatic

If the goal was really best outcomes why aren’t physicians monitored for potential underuse?   Overuse may cost money   Underuse costs lives

Mayo Clinic : < 25 % of High Risk MPS Referred for Angio F Kawahja submitted

SPARC: 50% Under referral for Cardiac Cath 1,703 Intermediate/high risks patients with CCTA, SPECT or PET Hachamovitch et al, JACC 2012;59: Normal or non-obstructive *p<0.001 Mildly Abnormal Moderately or Severely Abnormal *p<0.001 *p=0.979 Risk-adjusted or 90-day Catherization SPECTPETCTA

Hazards of Underutilization 9300 Patients with recent onset chest pains 57% appropriate patients did not get angio median follow-up: three years Hemingway et al, Annals of Int Med 2008;248:221 Angio +Angio – 11%22%Death or ACS HR : 2.5

ACC Appropriateness Categories Underuse and Adverse Outcomes Ko et al, JACC 2012; in press CABG Proportion of Cardiac Catherization (%) HR: 0.99 HR: 0.57 (p=0.12) n=311n=326n=991 PCI HR: 0.61 (p=0.009) Medical 1625 pts with Chronic CAD and Cath: 3 year risk : Death /ACS

The AUC are Dynamic Documents Meant to Change Over Time

How Will the AUC Change? J Am Coll Cardiol 2013;61:1305–17. Appropriate Uncertain May be appropriate Inappropriate Rarely appropriate

The AUC Process Has Been Refined The Writing Committee 3 Interventional Cardiologists 2 Cardiac surgeons 2 Health outcomes researchers Broader Representation More Extensive Review J Am Coll Cardiol 2013;61:1305–17.

Criticisms of the AUC Lack of adequate representation of interventional cardiology on the technical panel Lack of specific criteria for stress testing Inability to link stress test results to coronary anatomy Overdependence on pre- procedure stress testing Inadequate use of angiographic variables Validity of NCDR self-reported data J Am Coll Cardiol Intv 2012;5:

Criticisms of the AUC 1. The composition of the technical committee should change – more interventionalists 2. Nuclear perfusion scans should not be the single “gold standard” for determining the significance of a stenosis 3. More use of FFR, IVUS and OCT 4. The technical panel should be at liberty to form their recommendations without limitations, based on the current literature. 5. The endpoints to be considered should not be limited to mortality and cost. ACC Interventional Council-SCAI Review 6.The structure of the current AUC matrix has very limited scientific foundation in some areas.  Why 2 antianginals? 7.Anatomic based decisions regarding revascularization are obsolete. 8.Patient preference is a crucial aspect of clinical decision making, but is not considered in the AUC. 9.The writing committee should revamp the matrices that were constructed for stable coronary disease in a manner that incorporates how decisions for revascularization are made in actual practice

Attempt to Answer the Critics The matrix structure will be revamped The matrix structure will be revamped There will be a greater use of FFR in scenarios There will be a greater use of FFR in scenarios The recommendations for antianginals will follow the Stable IHD Guidelines The recommendations for antianginals will follow the Stable IHD Guidelines  J Am Coll Cardiol 2012;60:2564–603. Special scenarios will be developed for: Special scenarios will be developed for:  Pre-TAVR  Pre-solid organ transplant evaluation Other changes to answer some of the criticisms Other changes to answer some of the criticisms

“Just because its “inappropriate” doesn’t mean its not medically indicated “ Ralph Brindis, President ACC FDA Panel Hearing June, 2010

Conclusions The AUC are useful tools for program monitoring The terminology is finally changed (not without criticism) They should be used as system metrics and not for reimbursement Importantly we should be touting our success as practitioners as opposed to capitalizing on “finding fleas” on the interventional dog