the role of registries in ... - michigan chapter acc · american college of cardiology quality...

The Role of Registries inComparative Effectiveness Research

and Improving Care: Lessons from the ACC National

Cardiovascular Data Registry (NCDR)

Michigan ACC Chapter MtgOctober 17,2009

Ralph Brindis, MD, MPH, FACC, FSCAIPresident- Elect, American College of Cardiology

Senior Advisor for Cardiovascular Disease, Kaiser Permanente

Ralph Brindis, MD MPH FACC FSCAIConflicts of Interest/Relationships with Industry

NONE

The Role of Registries in Comparative Effectiveness Research and

Improving Care: Lessons from the ACC National


3

American College of Cardiology

Quality

AdvocacyEducation

ScienceIn the Service of

Patients

ACC’s Role in Measurement and Improvement

Define Care Standards Clinical Guidelines

Define Data Standards Data Standards

Develop Measures Performance Measures

Measure Quality ACC-NCDR

Improve Quality CathKIT

Appropriateness AUC

Bill Weintraub: NCDR Founding Father, CV Epidemiologist,Clinical Trialist and Outcomes Thought Leader

“Science tells us what we can do;

Guidelines what we should do;

Registries what we are actually doing.”

Registries what we will be doing!

Registries for Evidence Development and Dissemination

Timeline of building a true…

National

CardioVascular

Data

Registry

1998….. 2004 2005 2006 2007 2008 beyond

CathPCICathPCIRegistryRegistry

ICDICDRegistryRegistry

CARECARERegistryRegistry

ACTIONACTIONRegistryRegistry

IC3IC3

SPECT MPI

PADRegistry

EPRegistry

IMPACT Registry

ICD LongICD Long

Participants and Patient Records

Name # of Participants

# of Patient Records

Hospital CathPCI 1200 10 million

ICD 1500 400,000

ACTION-GWTG 425 150,000

CARE 160 15,000

IMPACTUnder

Development--

Practice IC3 600 230,000

Registries

CathPCI

ACTION-GWTG

CARE

ICD

Registry Studies

ICD Long.

AnalyticReporting Services

BCBSAWellPoint

UnitedWVMI

HCA

CMS

BMC2

Research& Publication Services

Yale

DCRI

MAHI

FDA ACC

Ad hocIndustry

IMPACT

Quality Improvement

What is the National Cardiovascular Data Registry?

Aetna

SPECT MPI

IC3

Standard Order Sets

Care Plans

• Guidelines Develop.• Educational Needs

Assess.• Market Intelligence

ACC

NCDR Management Board

Scientific Oversight Committee

Research &Publications

SteeringCommittee

CathPCIRegistry

CARE Registry

ICD Registry

ACTION Registry

IMPACT Registry IC3

QI Subcommittee

ACC BOT

CQC

Each Program includesthe following:

Multispecialty RepresentationCathPCI• Society for Cardiovascular Angiography and InterventionICD• Heart Rhythm SocietyCARE• Society for Cardiovascular Angiography and Intervention• Society for Interventional Radiology• American Academy of Neurology• American Academy of Neurosurgery• Society of Vascular Medicine and BiologyACTION• American Heart Association• Chest Pain Centers SocietyIMPACT• American Academy of Pediatrics

Influence of NCDR Research

• Public Policy • Quality Improvement: Guideline Adherence

– Reducing D2B Times– Clinical Indications & Outcomes • Quality Improvement: Translational Research

• Post Market Surveillance– Adverse Events in Closure Devices

• New Technologies and Effectiveness– Diffusion of New Technology

Executive Summary Performance MetricsExecutive Summary Performance Metrics

CathPCI 2007-2008

Age Distribution

14%

0.0

0.5

1.0

1.5

2.0

2.5

3.0

3.5

Age

<40 40-59 60-79≥80

InIn--Hospital PCI Mortality = 1.22%Hospital PCI Mortality = 1.22%

Singh M et.al Circ Cardiovasc Intervent 2009;2:20-2

Age & PCI Mortality 2001-2006

n=25,679 n=496,204 n=732,574 n=155,612

0.0

0.2

0.4

0.6

0.8

1.0

1.2

1.4M

orta

lity

(%)

Years2001 2002 2003 2004 2005 2006

Elective PCI PatientsElective PCI Patients

40-59≤40 69-79

≥80

Age

Singh M et.al Circ Cardiovasc Intervent 2009;2:20-26

Trends : Age & PCI Mortality

Pre-CathPCI Risk Models

Full Model † Precath Simple Model

Label O.R. 95% CIWald Chi-

SquareO.R. 95% CI

WaldChi-Sq

Age (for age<=70) ‡ 1.55 1.44 1.69 115.33 1.52 1.40 1.64 107.92

Age (for age>70) ‡ 1.71 1.57 1.88 125.80 1.76 1.60 1.91 150.93

Previous History - CHF 1.29 1.13 1.47 13.85 1.75 1.54 1.98 77.25

Peripheral Vascular 1.53 1.35 1.74 42.39 1.67 1.48 1.89 67.78

Chronic Lung Disease 1.48 1.31 1.66 43.04 1.52 1.36 1.71 52.87

GFR for stemi ‡ 0.77 0.74 0.80 181.90 0.77 0.75 0.78 377.55

Cardiogenic Shock at Admission

8.35 7.40 9.44 1168.28 12.19 10.86 13.68 1804.73

NYHA Class IV for STEMI 1.21 1.05 1.39 6.74 1.61 1.46 1.79 81.71

Urgent PCI Status- STEMI § 1.09 0.64 1.83 0.09 1.25 0.748 2.07 0.71

Emergency PCI Status-STEMI § 2.07 1.30 3.31 9.24 2.65 1.68 4.18 17.58

Salvage PCI Status-STEMI § 14.55 8.39 25.21 91.08 21.45 12.57 36.61 126.36

† Full model also includes Previous PCI, PreOp IABP, Ejection Fraction, Coronary Lesion >= 50%: SubacuteThrombosis (Y/N), Highest Risk Pre-Procedure TIMIFlow = none, Diabetes/Control, Highest Risk Lesion: SCAI Lesion Class 2 or 3, BMI for STEMI/non STEMI, Previous Dialysis for STEMI/non STEMI, Highest Risk Lesion Segment Category for STEMI/non STEMI. ‡ Per 10 unit increase. § Versus Elective

Arnold, S. V. et al. Arnold, S. V. et al. Circ Circ CardiovascCardiovasc QualQual Outcomes Outcomes 20082008

Personalized Informed Consent

Use of Reperfusion Therapy for STEMI

STEMISTEMIN = 20,998N = 20,998

ReperfusionReperfusionN = 16,374 (78%)N = 16,374 (78%)

No Reperfusion No Reperfusion ––No Contraindication ListedNo Contraindication Listed

N = 1163 (6%)N = 1163 (6%)

Not Eligible for Not Eligible for Reperfusion Therapy Reperfusion Therapy Contraindication Listed Contraindication Listed

N= 3,011 (14%)N= 3,011 (14%)

Primary PCI Primary PCI –– 86%*86%*FibrinolyticsFibrinolytics –– 13%*13%*

Both PCI + Both PCI + LyticsLytics –– 1%*1%*

* Among patients receiving reperfusion

ACTION Registry-GWTG DATA: January 1 – December 31, 2008ACTION Registry-GWTG DATA: January 1 – December 31, 2008

In-Hospital Outcomes -STEMI vs. NSTEMI

Variable STEMI

(n=20,998) NSTEMI

(n=31,774) Death* 5.8% 4.1% Re-infarction 1.1% 1.0% CHF 6.8% 7.5% Cardiogenic Shock 6.2% 2.7% Stroke 0.8% 0.7% RBC Transfusion# 6.4% 8.9%

* Unadjusted mortality# Transfusion among non-CABG patients* Unadjusted mortality# Transfusion among non-CABG patientsACTION Registry-GWTG DATA: January 1 – December 31, 2008ACTION Registry-GWTG DATA: January 1 – December 31, 2008

NSTEMI Revascularization Strategy Trends


45% 46% 46%

44% 42% 42%42%

45%

11%11%12%11%

0%

10%

20%

30%

40%

50%

60%

Q1 2008 Q2 2008 Q3 2008 Q4 2008

Medically Managed PCI CABG

STEMI Discharge Medications

99% 97%88%

93% 92%

0%

20%

40%

60%

80%

100%

ASA Beta Blocker ACE-I or ARB Statins Clopidogrel

% U

se%

Use


The D2B Quality Alliance:

A Case Study in Success

The D2B Quality Alliance:The D2B Quality Alliance:

A Case Study in SuccessA Case Study in Success

% D2B < 90 Minutes% D2B < 90 MinutesApril 2005 to April 2008April 2005 to April 2008

November 2006

010

2030

4050

6070

8090

100

% D

2B <

90

min

Apr 05

Jul 0

5

Oct 05

Jan 0

6

Apr 06

Jul 0

6

Oct 06

Jan 0

7

Apr 07

Jul 0

7

Oct 07

Jan 0

8

Apr 08

Month

D2B LaunchNovember 2006

53%63%

76%

Registries Can Define QI TargetsRegistries Can Define QI Targets

J Am Coll Cardiol, 2009; 53:161-166J Am Coll Cardiol, 2009; 53:161-166

27%

↓ Door to reperfusion times

↓ Risk-adjusted mortality

Pre-hospital ECG

Why does it matter? Mortality falls Why does it matter? Mortality falls even with decreases in already low timeseven with decreases in already low times!!CathPCI Registry 2005CathPCI Registry 2005--06 (N=43,801) Rathore et al, Circulation, AHA08 abstract #6174)06 (N=43,801) Rathore et al, Circulation, AHA08 abstract #6174)

Fractional Polynomial - Adjusted

Overall mortality 4.6%

Best fit from 3rd degree polynomial

P<0.001 for comparison with linear term

03

69

1215

Mor

talit

y (%

)

15 30 45 60 75 90 105 120 135 150 165 180 195 210 225 240Door-to-Balloon Time

Adjusted Mortality Rate95% CI: Low er Limit95% CI: Upper Limit

⇓⇓D2B from 90 toD2B from 90 to 6060 minutes associated withminutes associated with ⇓⇓0.8% Mortality0.8% Mortality

⇓⇓D2B from 60 toD2B from 60 to 3030 minutes associated withminutes associated with ⇓⇓0.5% Mortality0.5% Mortality

InIn--hospital hospital MortalityMortality

Quality can save MoneyU. M. Khot et. Al., Emergency Department Activation of the Catheterization Laboratory and Immediate Transfer to an Immediately Available Catheterization Laboratory to Reduce Door to Balloon Time in ST Elevation Myocardial Infarction. Circulation. 2007; 116

ED Activation of Cath Lab & Immediate Transfer by Care Team

•D2B decreased 113 min to 75 minutes•Transfer in 147 minutes to 85 minutes•Infarct size reduced (creatinine kinase)•LOS 5 +/- 7 days to 3 +/- 2 days•Cost $26K (+/- $29k) to $18K (+/- $9K)

FDA Statement

% DES Use NCDR CathPCI

% DES Use NCDR CathPCI

NCDR - Elective PCIPCI Volume with Mortality

Annual PCI

Volume

# of Sites

Number of Patients

(%)

Mortality (%)

Odds Ratio (95% CI)

(vs. volume ≥801)

0-200 43 6,305 (1.3) 0.49 1.17 (0.81 -1.71)

201-400 85 42,039 (8.7) 0.49 1.12 (0.96 -1.31)

401-800 132 116,116 (24.0) 0.45 1.10 (0.99 -

1.22)

≥801 139 318,500 (65.9) 0.39 ref.

NCDR Centers (n= 403) 2001 - 2004

Percutaneous Coronary Interventions in Facilities

without On-Site Cardiac Surgery: A Report from the National


Kutcher, MA, Klein LW, Ou F, Wharton TP, Dehmer GJ, Singh M, Anderson HV, Rumsfeld JS, Weintraub WS, Shaw RE, Sacrinty MT, Woodward A, Peterson ED,

Brindis RG. J Am Coll Cardiol 2009;54;16-24.

Study Population

NCDR CathPCI Registry Consecutive PCI cases

January 1, 2004 to March 30, 2006308,161 patients

465 centers

OFF-SITE Surgery Back-Up8,736 patients

60 centers

ON-SITE Surgery Back-up299,425 patients

405 centers

Risk Adjusted OutcomesSafety and Efficacy of PCI

Without On-site Surgical Back-up

Risk of Local Adverse Effects Following Cardiac Catheterization by Hemostasis Device and Gender

A Report from the NCDR inPartnership with the FDA

Dale Tavris, Syamal Dey, Albrecht Gallauresi, Richard Shaw, William Weintraub, Kristi Mitchell, Ralph Brindis

Grant from Office of Women’s Health, Food and Drug Administration

Risk of Local Adverse Effects Following Cardiac Catheterization by Hemostasis Device and Gender

A Report from the NCDR in Partnership with the FDA

Issues

• Physician specialty impact on ICD outcomes = unknown

Findings

• ICD implantation by non-electrophysiologist associated with higher risk of complications and lower likelihood to receive a CRT-D

Certification and Outcomes with ICDs

Curtis et al. , JAMA 2009; 301 (16) 1661:1670

Non-electrophysiologists implant almost a third of ICDs

Baseline Characteristics Stratified by Physician Certification by ICD type

Total, No. (%)

Physician Certification, No. (%)

EP CVD TS Other

ICD type (n=111,293) (n=78,857) (n=24,399) (n=1,862) (n=6,175)

Single-chamber

(25.0) (25.1) (25.6) (20.3) (22.3)

Dual-chamber

(40.0) (38.7) (41.2) (56.7) (46.2)

CRT (34.9) (36.0) (33.0) (23.0) (31.3)EP: Electrophysiologist, CVD: nonelectrophysiologist Cardiologist, TS; Thoracic Surgeon

Curtis et al. , JAMA 2009; 301 (16) 1661:1670


Complications Stratified by Physician Certification

Total, No. Physician Certification

EP CVD TS Other

n=111,293 n=78,857 n=24,399 n=1,862 n=6,175

Adverse events (%)

Any complication 3.5 3.3 3.8 5.5 3.8

Major Complication

1.3 1.2 1.5 2.2 1.5

Minor Complication

2.3 2.3 2.4 3.6 2.4

Higher risks of adverse events and complications for patients treated by non-electrophysiologists

EP: Electrophysiologist, CVD: nonelectrophysiologist Cardiologist, TS; Thoracic Surgeon

Curtis et al. , JAMA 2009; 301 (16) 1661:1670


Outcomes Following Coronary Stenting:A National Study of Long Term,

Real-World Outcomes of Bare-Metal and Drug-Eluting Stents

Pamela S. Douglas, J. Matthew Brennan, Kevin J. Anstrom, Eric L. Eisenstein, David Dai, Ghazala Haque, David F. Kong,

Ralph Brindis, Art Sedrakyan, David Matchar, Eric D. PetersonDuke Clinical Research InstituteDuke University Medical Center

Goal and PopulationGoal

To examine comparative effectiveness and safety of DES vs BMS in a national PCI cohort

Study population• All PCI pts > 65 yo in NCDR CathPCI 1/04-12/06 • Follow up obtained through linkage to CMS

inpatient claims data using indirect identifiers; 76% matched

Final cohort

262,700 pts83% DES; 46% Cypher, 55% Taxus

Analysis• 30 month outcomes

– Death, MI, Stroke, Revascularization, Major bleeding

Overall and in important subgroups

Outcomes adjustments– Inverse propensity weighted model (102 covariates)– Cox proportional hazards model (60 covariates)

Sensitivity analyses•Results in ‘RCT-like’ population•Non-CV ‘cause’ of death

DES & BMS Event Rates:30-month Adjusted

0

5

10

15

20

25

Death MI Revasc Bleeding Stroke

BMS

DES

Rat

e / 1

00 p

atie

nts

Outcomes Following Coronary StentingA National Study of Long Term, Real-World Outcomes of

Bare-Metal and Drug-Eluting Stents

Subgroup Analyses

MalesFemalesAge >= 75Age < 75Off LabelNo DiabetesDiabetes / non-insulin depDiabetes / insulin depElectiveUrgentSTEMINo Renal FailureNon-dialysis RFDialysisPrior PCINo Prior PCIPrior CABGNo Prior CABGCHF (current status)No CHF (current status)Prior MINo Prior MI1 Vessel Disease2 Vessel Disease3 Vessel Disease2004 PCI2005 PCI2006 PCI

Overall

.5 .6 .75 1 6 .75 1 1.25 6 .75 1 1.25

Death MI Revasc

Favors DES

Sensitivity Analysis:

Patient Selection

• RCT - like population • N = 49,355 (19%)• ‘Inclusion’ criteria

– Elective PCI, < 2 stents– Native vessel, de novo– Class A or B lesions – Lesion length, diameter – ASA, clopidogrel OK– No CKD

Death

Death or MI

MI

Revascularization

Stroke

Bleed

Overall

RCT Population

Overall

RCT Population

Overall

RCT Population

Overall

RCT Population

Overall

RCT Population

Overall

RCT Population

.5 .6 .75 1 1.25

Favors DES

Landmark Display: Mortality

0.00

0.02

0.04

0.06

0.08

0.10

0.12

0.14

0.16

0.18

0.20

0 6 12 18 24 30

Months

Even

t Rat

e

BMS DES BMS_6 DES_6 BMS_12 DES_12

• NCDR data can be linked to claims data• Data analysis allows a robust, longitudinal assessment

of clinical effectiveness• Comparing outcomes of DES to BMS at 30 months

– No major DES safety concerns– Lower death and MI rates in DES patients– Slightly lower revascularization, bleeding rates– Similar stroke rates

Conclusions

The Push for Comparative Effectiveness Reserach

Outcomes and Comparative Effectivness

2007 CBO Report

CER “Definition”

Clinical Registries !

Infrastructure Tool for CER

Registries can:

ACC and Comparative Effectiveness Research

• Stimulus for evidence development– High scientific rigor, impact on diversity• CER priorities set by Multi-stakeholder board

• Wise stewardship of resources– Quality of care first priority while reducing costs

secondary aim• Separate entities that generate CER and those that determine

coverage and benefit programs

• CER needs long-term support/investment• CER policies/programs implementation monitoring

National Data Repository for Comparative Effectiveness Research

National Data Repository for Comparative Effectiveness Research

CLAIMSNCDR CATHPCI

NDI

Pharm

STSRegistry

UPI

ACC/Duke Partnership: Develop a ACC/Duke Partnership: Develop a National Cardiovascular ResearchNational Cardiovascular Research

Infrastructure (NCRI)Infrastructure (NCRI)

• Purpose – Compare CABG and PCI using linked databases

from the CathPCI and STS Registries for in-hospital outcomes

• Clinical data linked to MEDPAR data for long-term survival and economic outcomes

• Develop prediction models of death after initial revascularization in setting of chronic CAD

• Purpose – Compare CABG and PCI using linked databases

from the CathPCI and STS Registries for in-hospital outcomes

• Clinical data linked to MEDPAR data for long-term survival and economic outcomes

• Develop prediction models of death after initial revascularization in setting of chronic CAD

NHLBI GO Grant Proposal:ACC/STS - CardioLINK

NHLBI GO Grant Proposal:ACC/STS - CardioLINK

Patient Patient 11

PatienPatient 1t 1

Patient Patient 22

Patient Patient 22

SYNTAX SCORE 21SYNTAX SCORE 21 SYNTAX SCORE 52SYNTAX SCORE 52

LCx 70LCx 70--90%90%

LAD 70LAD 70--90%90%

RCA2 70RCA2 70--90%90%

RCA3 70RCA3 70--90%90%

LM 99%LM 99%

LCx 100%LCx 100%

LAD 99%LAD 99%

RCA 100%RCA 100%

There is There is ‘‘33--vessel diseasevessel disease’’ and and ‘‘33--vessel diseasevessel disease’’

NCDR Temporal Experience

ACC/STS – CardioLINK ACC/STS – CardioLINK

Create propensity score for patients undergoing isolated CABG or PCI in stable CAD

Create a model to predict the SYNTAX score based on co-variables available in STS and NCDR databases

Compare long-term survival, hospitalization for MI, renal failure, stroke, and repeat revascularization using propensity scores from matched pairs and also by disease severity from derived SYNTAX scores

Create propensity score for patients undergoing isolated CABG or PCI in stable CAD

Create a model to predict the SYNTAX score based on co-variables available in STS and NCDR databases

Compare long-term survival, hospitalization for MI, renal failure, stroke, and repeat revascularization using propensity scores from matched pairs and also by disease severity from derived SYNTAX scores

ACC/STS – CardioLINK ACC/STS – CardioLINK

• Cost and incremental cost-effectiveness of CABG vs PCI for matched subgroups

• Outcomes in cost per life year gained and cost per quality-adjusted life year gained

• Cost and incremental cost-effectiveness of CABG vs PCI for matched subgroups

• Outcomes in cost per life year gained and cost per quality-adjusted life year gained

CER and RegistriesCER and RegistriesPerfect Opportunity for Coverage with

Evidence Development (CED)

– Offers the “Carrots” and “Sticks” for Registry participation

– Realizes opportunities to assess new technology in real world applications –non-RCT and off label uses

Percutaneous Aortic ValvesAtrial Fibrillation Ablation

New CV Imaging Technologies

Perfect Opportunity for Coverage with Evidence Development (CED)

– Offers the “Carrots” and “Sticks” for Registry participation

– Realizes opportunities to assess new technology in real world applications –non-RCT and off label uses

Percutaneous Aortic ValvesAtrial Fibrillation Ablation

New CV Imaging Technologies

CER and RegistriesCER and Registries

• The integral role that Registries will play in CER needs to be financially supported at both the hospital/clinician level and at the Registry infrastructure level

• With a robust national data repository, the goal of CER will be ideally achieved

• The integral role that Registries will play in CER needs to be financially supported at both the hospital/clinician level and at the Registry infrastructure level

• With a robust national data repository, the goal of CER will be ideally achieved

Appropriate Use Appropriate Use Criteria Criteria

•

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

Development of CPG’s, Performance Measures, and Appropriate Use Documents

Development of CPGDevelopment of CPG’’s, Performance Measures, s, Performance Measures, and Appropriate Use Documentsand Appropriate Use Documents

Antman, Circulation 2009:119:1180-1185.

Guidelines and AUC• Clinical Practice Guidelines (State of Science)

• 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 • Selective indications• Largely guideline based• Clinical scenarios/frequency • “Reasonable to do”

• Used to evaluate practice patterns

• Clinical Practice Guidelines (State of Science)• 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 • Selective indications• Largely guideline based• Clinical scenarios/frequency • “Reasonable to do”

• Used to evaluate practice patterns

• SPECT-MPI• CCT/MRI• TTE/TEE Echocardiography• Stress Echocardiography • Coronary Revascularization: PCI/CABG • Implementation of AC Pilot(s) • Congestive Heart Failure• Acute Chest Pain• CV imaging Cross Modality Appropriateness

Appropriate Use Criteria

“Quality assessment is a complex process that includes more than mere tabulation of success and complication rates. Components of quality…includeappropriateness of case selection… A quality program performs appropriatelyselected procedures…”

“Quality assessment is a complex process that includes more than mere tabulation of success and complication rates. Components of quality…includeappropriateness of case selection… A quality program performs appropriatelyselected procedures…”

2005 ACC/AHA/SCAIPCI Guidelines

Quality Assessment Process

Median = 8 / 1000

Range = 3 -

Median = 8 / 1000

Range = 3 -Wennberg, D. The Dartmouth Atlas of Cardiovascular Health Care 1999

Six-Fold Geographic Variations in Age-Adjusted Coronary Interventional

Procedure Rates

Six-Fold Geographic Variations in Age-Adjusted Coronary Interventional

Procedure Rates

Median = 8 / 1000

Range = 3 - 20

Redding

UnprotectedLeft Main PCIUnprotectedUnprotected

Left Main PCILeft Main PCI

Potential Impact ofInappropriate PCI

Potential Impact ofInappropriate PCI

• 900,000 PCI/yr in US

• 6% inappropriate and 38% uncertain (NY/Rand)

• 0-25% of uncertain PCI are actually inappropriate

• 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~700 - 1700 deaths avoidable by eliminating inappropriate PCI

Inappropriate PCI

Indications Class Frequencies*

Anderson et al. , Circulation 2005; 112:2786

21%

7%8%

64%Class IIa

Class I

Class IIb

Class III

Procedure Indications and Outcomes of PCIs

* Including only classified procedures

Adverse Events Rates by Indications Class

Anderson et al. , Circulation 2005; 112:2786

0

0.5

1

1.5

2

I IIa IIb III

MICABGDeath

p<0.0001for all

Adv

erse

Eve

nts

(%)

ACC/AHA Class

Procedure Indications and Outcomes of PCIs

Framework for Decision MakingFive Core Variables

Framework for Decision MakingFive Core Variables

SYM

PTO

MS

SYM

PTO

MS

STA

BIL

ITY

STA

BIL

ITY

ISC

HEM

IAIS

CH

EMIA

MED

ICA

L R

xM

EDIC

AL

Rx

AN

ATO

MY

AN

ATO

MY

Stable angina

STEMISTEMI

Class IASx

Class IVClass IV

NoneLow risk

HighHighriskrisk

None

MaxMax

No sig.CAD

LM +LM +3v CAD3v CAD A

U

I

LowLow--Risk Findings on Noninvasive Imaging Study Risk Findings on Noninvasive Imaging Study And Asymptomatic And Asymptomatic

(Patients Without Prior Bypass Surgery)(Patients Without Prior Bypass Surgery)Noninvasive testingNoninvasive testing

Symptoms/RxSymptoms/Rx

Burden of diseaseBurden of disease

Stress or Imaging Studies Performed5100 : O No O Yes →If Yes, Specify Test Performed:

Test Performed No Yes Result Risk/Extent Of Ischemia

Standard Exercise Stress Test5200,5201,5202: (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 Echocardiogram5210,5211,5212: 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/SPECTMPI5220,5221,5222 :

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/CMR5230,5231,5232: O O →If Yes,O Negative O Positive O Indeterminant O Unavailable → If Positive,

O Low O Intermediate O High O Unavailable

Cardiac CTA5240,5241: O O →If Yes, O No disease O 1VD O 2VD O 3VD O Indeterminant O Unavailable

Coronary Calcium Score5250: O O → If Yes, Calcium Score:5251____________

Noninvasive testing v4 Data Set

Successful AUC Implementation

• Use the evidence we have to build an informed evaluation or treatment decision

• Quality, cost, and outcomes driven by informed evaluation or treatment decision

• Involve the patient to extent possible• Should ideally then reduce both geographic

variation and disparities of care (over and under use)

• Increase (in a good way) patient-centered variation in procedures

• Use the evidence we have to build an informed evaluation or treatment decision

• Quality, cost, and outcomes driven by informed evaluation or treatment decision

• Involve the patient to extent possible• Should ideally then reduce both geographic

variation and disparities of care (over and under use)

• Increase (in a good way) patient-centered variation in procedures

Evaluations of Appropriateness in Coronary Revascularization

•• AHA Outcomes Grants :AHA Outcomes Grants :–– Spertus MAHI, KaiserSpertus MAHI, Kaiser--StanfordStanford

•• California COIN initiativeCalifornia COIN initiative–– Payers, Leapfrog, Hospitals, ? Cal ACC Payers, Leapfrog, Hospitals, ? Cal ACC

Chapter, UCSF IHPSChapter, UCSF IHPS•• Northern New England ConsortiumNorthern New England Consortium•• NY State RegistryNY State Registry•• Washington State and moreWashington State and more

Challenges with Challenges with Appropriateness Use RatingsAppropriateness Use Ratings

•• Rely on collection of currently unavailable clinical Rely on collection of currently unavailable clinical data to map patients to appropriateness ratingsdata to map patients to appropriateness ratings•• Can the data be collected?Can the data be collected?

•• Can patients be mapped to the prototypical scenarios?Can patients be mapped to the prototypical scenarios?

•• Still being validatedStill being validated

•• No data demonstrating improved outcomes with No data demonstrating improved outcomes with their applicationtheir application

“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

“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