Appropriate Use Criteria are Inappropriately Used

Jeffrey W. Moses, MDJeffrey W. Moses, MD

Disclosure Statement of Financial InterestDisclosure Statement of Financial Interest

• Consulting Fees/HonorariaConsulting Fees/Honoraria • BSC,CordisBSC,Cordis

Within the past 12 months, I or my spouse/partner have had a financial Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below.interest/arrangement or affiliation with the organization(s) listed below.

Affiliation/Financial Relationship Company

Symptoms Med. Rx

Class llI or lV Max Rx U A A A AClass I or lI Max Rx U U A A AAsympto-matic Max Rx

I I U U UClass llI or lV No/min Rx

I U A A AClass I or lI No/min Rx

I I U U UAsympto-matic No/min Rx

I I U U UCoronary 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 2009 53 (February): 530-553

Asymptomatic

Stress Test Med. Rx

High Risk Max Rx U A A A AHigh Risk No/min Rx

U U A A AInt. Risk Max Rx U U U U AInt. Risk No/min Rx

I I U U ALow Risk Max Rx I I U U ULow Risk No/min Rx

I I U U UCoronary 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 1950-2005

Annual Reviews

Ford ES, Capewell S. 2001Annual Rev. public Health 32:5-22

ICD-7 (420) ICD-8 (410-413)

ICD-9 (410-414)

ICD-10 (120-125)

1950

1959

1956

1953

1962

1971

1968

1965

1974

1983

1980

1977

1986

1995

1992

1989

1998

2001

2004

100

0

Per

100

,000

po

pu

lati

on

200

300

400

500

600

5569

3827

1742

4748

3667

1081

0

1000

2000

3000

4000

5000

6000

Total PCI CABG

US Revascularization Rates

Epstein et al, JAMA 201;306:1769

From the beginning of the decade to 2008 –

PCI is Down …and still fallling!

2001-2002

2007-2008

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

ACS 350,469 (98.6%)

1,055 (0.3%) 3,893 (1.1%) 355,417

Non-ACS 72,911 (50.4%)

54,988 (38.0%)

16,838 (11.6%) 144,737

Total 423,380 (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.

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?

0

5

10

15

20

25

30

Cu

mu

lati

ve i

nci

de

nce

(%

)

166 156 145 133 117 106 93 74 64 52 41 25 13Registry447 414 388 351 308 277 243 212 175 155 117 92 53PCI+MT441 414 370 322 283 253 220 192 162 127 100 70 37MT

No. at risk

0 1 2 3 4 5 6 7 8 9 10 11 12

FAME 2: Primary Outcomes

MT vs. Registry: HR 4.32 (1.75-10.7); p<0.001

PCI+MT vs. Registry: HR 1.29 (0.49-3.39); p=0.61

PCI+MT vs. MT: HR 0.32 (0.19-0.53); p<0.001

Months after randomization

De Bruyne B et al. NEJM 2012:on-line

0

5

10

15

20

25

30

Cu

mu

lati

ve in

cid

ence

(%

)

0 7days 1 2 3 4 5 6 7 8 9 10 11 12

Months after randomization

p-interaction: p=0.003

>8 days: HR 0.42 (0.17-1.04); p=0.053

≤7 days: HR 7.99 (0.99-64.6); 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

0

0.5

1.0

1.5

2.0

2.5

Cu

mu

lati

ve

in

cid

en

ce

(%

)

0 1 2 3 4 5 6 7Days 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;57:1546-1553

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; 57:1546-1553

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 U A A A AClass I or lI Max Rx U U A A AAsympto-matic Max Rx

I I U U UClass llI or lV No/min Rx

I U A A AClass I or lI No/min Rx

I I U U UAsympto-matic No/min Rx

I I U U UCoronary 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 2009 53 (February): 530-553

Asymptomatic

Stress Test Med. Rx

High Risk Max Rx U A A A AHigh Risk No/min Rx

U U A A AInt. Risk Max Rx U U U U AInt. Risk No/min Rx

I I U U ALow Risk Max Rx I I U U ULow Risk No/min Rx

I I U U UCoronary 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, Hachamovitch et al, JACCJACC 2012;59:462-474 2012;59:462-474

Normalor non-obstructive

*p<0.001

MildlyAbnormal

Moderately or SeverelyAbnormal

*p<0.001*p=0.979

Ris

k-ad

just

ed o

r 90

-day

Cat

her

izat

ion SPECT PET CTA

0.8

0.7

0.6

0.5

0.4

0.3

0.2

0.1

0.0

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

0

10

20

30

40

50

60

70

80

Inappropriate Uncertain Appropriate

ACC Appropriateness Categories

Underuse and Adverse OutcomesUnderuse and Adverse Outcomes

Ko et al, JACC 2012; in press

CABG

Pro

po

rtio

n o

f C

ard

iac

Cat

her

izat

ion

(%

)

HR: 0.99HR: 0.99HR: 0.57HR: 0.57(p=0.12)(p=0.12)

n=311 n=326 n=991

PCI

HR: 0.61HR: 0.61(p=0.009)(p=0.009)

Medical

1625 pts with Chronic CAD and Cath: 3 year risk : Death /ACS

The AUC are Dynamic Documents Meant The AUC are Dynamic Documents Meant to Change Over Timeto Change Over Time

How Will the AUC Change?How Will the AUC Change?

J Am Coll Cardiol 2013;61:1305–17.

• Appropriate Appropriate• Uncertain May be

appropriate• Inappropriate Rarely appropriate

The AUC Process Has Been RefinedThe AUC Process Has Been Refined

The Writing Committee3 Interventional Cardiologists2 Cardiac surgeons2 Health outcomes researchers

BroaderRepresentation

MoreExtensive

Review

J Am Coll Cardiol 2013;61:1305–17.

Criticisms of the AUCCriticisms 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 IntvJ Am Coll Cardiol Intv 2012;5:229-235. 2012;5:229-235.

Criticisms of the AUCCriticisms of the AUC

1.1. The composition of the technical The composition of the technical committee should change – more committee should change – more interventionalistsinterventionalists

2.2. Nuclear perfusion scans should not Nuclear perfusion scans should not be the single “gold standard” for be the single “gold standard” for determining the significance of a determining the significance of a stenosisstenosis

3.3. More use of FFR, IVUS and OCTMore use of FFR, IVUS and OCT

4.4. The technical panel should be at The technical panel should be at liberty to form their liberty to form their recommendations without recommendations without limitations, based on the current limitations, based on the current literature. literature.

5.5. The endpoints to be considered The endpoints to be considered should not be limited to mortality should not be limited to mortality and cost. 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 CriticsAttempt to Answer the Critics

• The matrix structure will be revampedThe matrix structure will be revamped

• There will be a greater use of FFR in There will be a greater use of FFR in scenariosscenarios

• The recommendations for antianginals The recommendations for antianginals will follow the Stable IHD Guidelineswill follow the Stable IHD Guidelines J Am Coll Cardiol 2012;60:2564–603.J Am Coll Cardiol 2012;60:2564–603.

• Special scenarios will be developed for:Special scenarios will be developed for: Pre-TAVRPre-TAVR Pre-solid organ transplant evaluationPre-solid organ transplant evaluation

• Other changes to answer some of the Other changes to answer some of the criticisms criticisms

“Just because its “inappropriate”

doesn’t mean its not medically indicated “

Ralph Brindis, President ACCFDA Panel HearingJune , 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