Ralph G. Brindis, MD, FACCChief Medical Officer

ACC-NCDRNovember 4, 2007

NNational

CCardiovascular

DData

RRegistry

NCDR:Physicians Leading

the Effort To Quantify Quality

CVS.42: Quality Improvement Initiatives in Cardiology

NCDR:Physicians Leading

the Effort To Quantify Quality

CVS.42: Quality Improvement Initiatives in Cardiology

Disclosure Information

NCDR: Physicians Leading the Effort To

Quantify Quality

Ralph Brindis, MD, MPH, FACC, FSACI

Grant support (GS), consultant (C), speakers bureau (SB), stock options (SO), equity interest (EI):

NONE

Off label use of products will (not) be discussed in this presentation:

NONE

Mission of the NCDR™

To improve the quality of cardiovascular patient care by

providing information, knowledge and tools; implementing quality

initiatives; and supporting research that improves

patient care and outcomes.

NCDR is…

National CardioVascular

Data

Registry

1998….. 2004 2005 2006 2007 2008 beyond

CathPCICathPCIRegistryRegistry

ICDICDRegistryRegistry

CARECARERegistryRegistry

ACTIONACTIONRegistryRegistry

IC3 CADIC3 CAD

ImagingRegistry

HFRegistry

PracMgtRegistry

PADRegistry

EPRegistry

Ped.Registry

Congenital

Registry

Building a true…Building a true…

ICD LongICD Long

AchieveAchieve

Registry ProjectsRegistries QI Projects

NCDRManagement

BoardNCDR Operations Leadership Team

Data Safety Monitoring Board

Scientific Oversight Committee

Research &Research &PublicationsPublications

Clinical Clinical Support.Team Support.Team

SteeringSteeringCommitteeCommittee CathPCCathPC

I I RegistrRegistr

yy

CARE CARE RegistrRegistr

yy

ICD ICD RegistrRegistr

yy

Committee structurefor each registry

Includes 30dayoutcomes

ACTIOACTION N

RegistrRegistryy

ICIC3 3 ProgramProgramSteering Committee

ACHIEVE RegistryACHIEVE RegistrySteering Committee

ICD Longitudinal ICD Longitudinal ProgramProgram

Steering Committee

Take ACTION Take ACTION CampaignCampaign

Planning Work Group

NCDR-D2B ProjectNCDR-D2B ProjectManaged by ACTION and

CathPCI Steering Committees

ambulatory

longitudinal

longitudinal

QualityKIT/QualityKIT/CathKITCathKIT

TBDQI Subcommittee QI Subcommittee

Version 10/29/07

Advisory CouncilIndustryFederal

Health PlansPatients

Executive Summary Page

CathPCI™ Report: Executive Summary

Median

75 Pctl25 Pctl

90 Pctl10 Pctl

Your Hospital

Best Practice

Indicator

Detail Line Number

Rank percentile

Rank

Your Hospital

Registry/QI• >985 hospitals• 6 million patient records• 2 millions PCI records• Online data entry tool • Support D2B AllianceAnalytic Reporting

Services• States – MA, OH, WV, ?

CT, ?NJ• Payers – United, BCBSA,

WellPointResearch and Publications• DCRI analytic center• Over 100 publications

190272

321 362

472547

658

825

1000

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Facil

ities

1999 2000 2001 2002 2003 2004 2005 2006 2007F

CathPCI Registry Enrollment

Participants

• Registry• 1425 enrolled• 200,000 patient records• Analytic Reporting Services• UHC • Discussions with BCBSA• Provide data to CMS for

reimbursement• Research• Abstracts at AHA• ICD Longitudinal Study• Performing analysis for

FDA

110

325

746

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12431324 1338 1350

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2/1/2006 4/1/2006 6/1/2006 8/1/2006 10/1/2006 12/1/2006 2/107

ICD Registry Enrollmennt

Participants

• Registry• 235 Participants• > 3,000 patient

records• Data entry tool• CMS data requirement• Research• Analysis for FDA• Discussion with

industry - PMS8 13

2542 45

5774

8798

154

198

235

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Sep-06

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CARE Registry Participationt

Participants

Registry• 300 participants• Over 30,000 records by

9/07• Funding provided by

– Genentech– Bristol-Myers

Squibb/Sanofi Partnership

– Schering Plough Corporation

Analytic Reporting Services• Early discussions with

payers

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Jan-07 Feb-07 Mar-07 Apr-07 May-07 Jun-07 Jul-07 Aug-07

ACTION Registry Participationt

Participant

ConceptConcept

OutcomesOutcomes

Clinical Trials

Clinical Trials

GuidelinesGuidelines

PerformanceIndicators

PerformanceIndicators

PerformancePerformancePerformancePerformance

QUALITYQUALITY

NCDR: ICD,ACTION, CARE,CathPCI& STS

NCDR: ICD,ACTION, CARE,CathPCI& STS

The Cycle of Clinical Therapeutic Effectiveness

Benchmarking: Primary PCI % <90 Minutes

Percentage of Primary PCI with D2B <= 90 minutesNCDR CathPCI v3

0%

10%

20%

30%

40%

50%

60%

70%

80%

Timeframe

Perc

enta

ge

2004 STEMI ACC/AHA Guideline Update &JCAHO Core Measure

D2B Alliance Launch

ACC-Quality/CathKIT™

CQI TutorialMeeting Standards

Reporting & OutcomesImplementing CQI

Hospital PCI Volume and In-Hospital MortalityACC-NCDR® 2001-2004

Hospital PCI STEMI Non-STEMI ElectiveVolume (pts) n=90,256 pts n=94,587 pts

n=482,960 pts

≤200 vs >800 0.99 (0.75,1.31) 0.64 (0.38,1.06) 1.17 (0.81,1.71)

201-400 vs >800 0.96 (0.83,1.12) 0.87 (0.68, 1.10) 1.12 (0.96, 1.31)

401-800 vs >800 0.95 (0.85,1.07) 0.96 (0.81,1.14) 1.10 (0.99,1.22)

Mortality 4.83% 2.09% 0.41%

Hospital PCI STEMI Non-STEMI ElectiveVolume (pts) n=90,256 pts n=94,587 pts

n=482,960 pts

≤200 vs >800 0.99 (0.75,1.31) 0.64 (0.38,1.06) 1.17 (0.81,1.71)

201-400 vs >800 0.96 (0.83,1.12) 0.87 (0.68, 1.10) 1.12 (0.96, 1.31)

401-800 vs >800 0.95 (0.85,1.07) 0.96 (0.81,1.14) 1.10 (0.99,1.22)

Mortality 4.83% 2.09% 0.41% (Odds Ratio, 95% CI)(Odds Ratio, 95% CI)Zhang et al Circulation 2005 Suppl II;112:792.Zhang et al Circulation 2005 Suppl II;112:792.

Performing Percutaneous Coronary Interventions at Facilities Without On-Site Cardiac Surgical Backup is IncreasingA Report FromThe American College of Cardiology - National Cardiovascular Data Registry

Dehmer GJ, et.al. Am J Cardiol 2007;99:329-332.

URGENT NON-ELECTIVE PCI

y = 1.28x + 2.934R2 = 0.97, P<0.0001

y = -1.28x + 97.07R2 = 0.97, P<0.0001

0

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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16

(1='2001Q1', 2='2001Q2',…,16='2004Q4')QUARTER

PR

OP

OR

TIO

N (

%)

With no Surgical Backup

With Surgical Backup

Proportion of Urgent PCIs with and withoutOn-site Surgical Back-up

Jan 2001 Dec 2004 Calendar Quarter

Proportion of Elective PCIs with and without On-site Surgical Backup

ELECTIVE PCI

y = -0.63x + 99.37R2 = 0.71, P<0.0001

y = 0.63x + 0.63R2 = 0.71, P<0.0001

0

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1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16

(1='2001Q1', 2='2001Q2',…,16='2004Q4')QUARTER

PR

OP

OR

TIO

N (

%)

With no Surgical Backup

With Surgical Backup

Jan 2001 Dec 2004 Calendar Quarter

PCI With or Without Onsite Surgery Standby

ACC-NCDR® 2001-2004

In-hospital Mortality : Offsite vs Onsite CVSx

Mortality Odds Ratio 95% CI P-value

No Acute MI (n=482,018) 0.54% vs 0.41% 1.04 (0.67,1.62) 0.87

STEMI (n= 90,050) 4.65% vs 4.83% 0.96 (0.72,1.26) 0.75

NSTEMI (n=94,347) 1.94% vs 2.09% 0.67 (0.40,1.11) 0.12

PCI With or Without Onsite Surgery Standby

ACC-NCDR®: January 2004 - March 2006

• 404 centers with Surgical Back-up• 61 centers without Surgical Back-up

• 299,132 pts from centers with SOS• 9,029 pts from centers without SOS

– 13% of Registry PCI patients

• Data verified via Quality Initiative Query

PCI With or Without Onsite Surgery Standby

ACC-NCDR® January 2004-March 2006

• Unadjusted and Risk Adjusted Mortality• Emergency CABG rate and CABG Mortality• Elective and Emergent PCI • Procedural success• Door to Balloon times• Descriptors of care:

– PCI Volume, distance/time/mode of travel for off site Surgery, hospital characteristics, lesion risk, clinical variables for risk adjustment

Improving Continuous Cardiac Care

Office-Based Registry

Improving Continuous Cardiac Care –In the Office

• The first CAD office-based registry– assess physician adherence to ACC/AHA clinical

practice guidelines – includes patients with Hx of ACS, prior PCI

and/or CABG.

• Powerful tool that allows MD/Payer to assess and improve current office-based clinical care.

Philosophy of the IC3 Program

• Make it easier for busy clinicians to do the right thing for the right patient at the right time– Track key performance measures

• Internal QI and P4P reporting at the practice level

– Make care more efficient• A worksheet that readily identifies opportunities to

apply CAD guideline recommendations and performance measures

– Coordinate care• Create a visit summary to communicate with patients

and other providers

Measuring CAD Care

Patient withstable angina

Onset of AcuteCoronary Syndrome

Post-Hospitalization:Risk factor modificationCardiac rehabilitationD/C

PCI/CABGAdmit

AMI Care

NCDR

ACTIONCath/PCI

IC3IC3

ACTION Follow-up

The IC3 Registry

Pt presents for visit, reports

med changes

Vitals, health status

assessed

Physician Visit & Rx

Data entered

and Clinic Visit Form Generate

d

Treatment plan Data

entered

Patient Letter &

Visit Summary dispensed

Visit Summary

sent to other care

providers

Data Entered through

NCDR IC3

IC3 Program Goals

• Provide QI tools designed for the entire office-based clinical care team

• Create QI tools directed at patients to become active participants and advocates for their own healthcare

• Explore strategies to support continuity of care among the multiple providers caring for an individual patient

• Provide real-time reporting of office-based quality indicators derived from clinical practice guidelines recommendations

IC3 Program Goals

• Create a trusted mechanism for measuring performance

• Serve as a valuable resource for research aimed at improving the treatment and outcomes of ACS/CAD patients in an ambulatory setting

• Support evolving CMS outpatient quality measures and regulatory reporting initiatives

• Support Pay-for-Performance programs

Sample QI Strategies

• Patient education resources– Overview of ACS/CAD– Explanation of treatment recommendations

• Visit-based summaries of treatment plans– Printable versions for patients – Encourage physician to physician

communication

• Office identification and tracking systems• Dissemination of best practices Health

status tools and reporting features

ACC’s Appropriateness Criteria:

SPECT-MPICardiac CTCardiac MRIEcho: TTE/TEE & Stress Coronary Revascularization: PCI/CABG

64 Slice 64 Slice Coronary CTCoronary CT

64 Slice 64 Slice Coronary CTCoronary CT

Tools for Achieving Quality in Imaging

Patient Testselection

Image acquisition

Imageinterpretation

Resultscommunication

Better patient

care

ACC-Duke Think Tank 2006 JACC 2006 48: 2141

RegistriesResearch

Appropriateness criteriaBenchmarkingProvider education

Lab accreditationTechnologist cert.

Lab accreditationPhysician trainingPhysician competency

Key data elementsUniform structured reportsTimeliness standards

Pilot Study:Evaluation of Appropriatenessof SPECT MPI

The American College of Cardiology The American Society of Nuclear

CardiologyNCDR

Purpose of the Project

• Facilitate quality improvements– Efficient, effective patient care

• Evaluate & promote awareness of appropriateness criteria in practice

• Provide feedback reports to improve both practice-level and individual physician-level adherence to the criteria

• Establish benchmarks to guide performance improvement

• Provide an alternative to prior authorization

SPECT MPI Appropriateness Criteria

Implementation ProgramPaper form and web-based portal for SPECT-MPI data collection, including indications for tests and test results

Analysis of practice patterns based on appropriateness criteria

Feedback of benchmarked practice patterns to physicians

\

0%

20%

40%

60%

80%

100%

Cardiologist PCP

Inapprop

Uncertain

Approp

Appropriateness Based on Physician Ordering

21%

7%

8%

64%

Class IIb

Class IIa

Class I

Class III

Anderson et al. Circulation 2005; 112:2786 Indications

Relationship between Procedure Relationship between Procedure Indications & Outcomes of PCI: ACC/AHA GuidelinesIndications & Outcomes of PCI: ACC/AHA Guidelines

ACC-NCDR

0

0.5

1

1.5

2

I IIa IIb III

ACC/AHA Class

%

MI

CABG

Death

p<0.0001for all

Anderson et al.

Circulation 2005; 112:2786

Adverse Events

Relationship between Procedure Indications and

Outcomes of PCI by ACC/AHA Guidelines

ACC-NCDR

Special Efforts in PCI Outcomes Evaluation: DES/BMS Dual Antiplatelet Therapy• NCDR Strengths:

– Consecutive patients– Audited data– Widespread participation > 1 million/year vs

15k clinical trial– “Real life” patients (co-morbid conditions,

older)– “Real life” physicians (ask Rob Califf)– Successful FDA – NCDR Groin closure study– Analytical centers/CV outcomes experts

Special Efforts and DES/DAP going Forward

• Missing Elements/Challenges

– Longitudinal Projects/Registries difficult to launch• Patient, Hospital, MD, Industry incentives• Burden of longitudinal data collection- varying models• HIPAA issues- unique patient identifiers• IRB approval - not required for “In hospital” QI Registries

but would most likely required for longitudinal f/u• Funding, funding, funding, funding

– Registries- good for QI, safety, and measuring and benchmarking many outcomes but not ideal/challenging for use in clinical trials

NCDR Data Merging Partnerships

AHRQ- DEcIDE Collaborative with DCRI

– NCDR patients• 600 sites, 2002-2006- 900,000 PCI’s of which 712,000

DES

– Linkage of NCDR with complete Medicare files• Creating a longitudinal database

– Linkage with HMORN• Kaiser patient data-pharmacy, costs, and longitudinal

results

– Real world outcomes assessment tracking DES use/outcomes

AHRQ- DEcIDE Collaborative with DCRI

• Linkage procedure via probabilistic matching

– Provider #, record #(unique encrypted identifier), DOB, sex, admit/discharge dates

– Match with CMS with very high degree of accuracy

– HIPAA compliant- “limited dataset” without patient direct identifiers (no name or SSN)

– Longitudinal records: f/u hospitalizations, death

AHRQ- DEcIDE Collaborative with DCRI

• Goals

– Describe temporal trends of DES/BMS– Analyze downstream DES/BMS patient outcomes

• readmissions, MI’s, repeat revascularizations, and death• Role of DAT- length of use post implantation

– Create conceptual model of stent decision making– Feedback to clinicians-outcomes, workshops,

publications, education tools, etc

AHRQ- DEcIDE Collaborative with DCRI

• Advantages of NCDR large patient base– Assess low frequency adverse events– Subgroup patients of interest:

• Women• Minorities• Diabetes• Acute coronary syndromes• Very elderly (>80years)• Renal failure