NCDR Registries - Integrated Healthcare Association

NCDR Registries:
The Present and the Future
Role in Device Surveillance and
Cardiac Service Line Quality Oversight
Ralph Brindis, MD, MPH, FACC
Chief Medical Officer, ACC National Cardiovascular Data Registry
Vice President, American College of Cardiology
Senior Advisor for Cardiovascular Disease, Northern California Kaiser Permanente
May 22, 2008
UC Irvine, California

National Cardiovascular Data Registry
Imaging
Registry
Timeline and growth…
ICD Long
IMPACT
Registry
EP
Registry
IC3-Office
PAD
Registry
CathPCI
Registry
ICD
Registry
CARE
Registry
ACTION
Registry
HF
Registry
1998….. 2004 2005 2006 2007 2008 beyond

What is the National Cardiovascular Data Registry?
Registries
Analytic
Reporting Services
WellPoint CMS BCBSA
CathPCI
IMPACT
WVMI
United
BMC2
Aetna
ICD
IC3
HCA
Research
& Publication Services
CARE
FDA
Yale
ACC
ACTION
Industry
DCRI
MAHI
Ad hoc
Registry Studies
Quality Improvement
TAKE ACTION
SPECT MPI
QI KIT
ICD Long.
Field Base Consultants

Committee Structure and Project Summary
NCDR Management Board
Scientific Oversight Committee
Data Monitoring Board
Committee Structure for
each Registry
Steering
Committee
Registries
Registry Projects
QI Projects
Clinical Supp.Team
Research &
Publications
ACTION
Registry
ambulatory
IC3
Steering Committee
TAKE ACTION
Planning Work Group
CathPCI
Registry
longitudinal
ACHIEVE
Steering Committee
D2B
Project managed through
ACTION and PCI Steering
committees
ICD
Registry
longitudinal
ICD Longit.
Steering Committee
CARE
Registry
Includes 30day
outcomes
Over 130 of our nation’s
CV Outcomes experts involved

NCDR Founding Father
Bill Weintraub

“Science tells us what we can do;
Guidelines what we should do;
Registries what we are actually doing.”

The Cycle of Clinical
Therapeutic Effectiveness
Concept
Clinical
Trials
Guidelines
NCDR:
ACTION
Cath PCI
& STS
Outcomes
QUALITY
Performance
Performance
Indicators

Uses of Registry Data
• Quality Improvement
• Research/Clinical Practice Guidelines
• Post-Market Surveillance
• Informed Decision Making in Real Time
• Maintenance of Certification & Privileging
• Meet Regulatory Needs
• Pay for Participation, Reporting, and Performance
• Utilization Data and Metrics

Registry/QI
• 1000 hospitals
• >6 million patient records
• Online data entry tool
• Support D2B Alliance
ARS
• States – MA, OH, WV,
?CT, ?NJ, ?CA
• Payers – United, BCBSA,
WellPoint
Research and Publications
• DCRI analytic center
• Over 100 publications
Facilities
1000
900
800
700
600
500
400
300
200
100
0
CathPCI Registry Enrollment
825
658
547
472
362
321
272
190
1000
1999 2000 2001 2002 2003 2004 2005 2006 2007F
Participants

CON/Legislative Mandate
• Massachusetts Department of Health
• West Virginia Health Care Authority
• Michigan Department of Community Health
• New Jersey Department of Health

States Considering
CathPCI Registry Adoption
• Maryland Health Care Commission
• California
– Health care reform legislation
• OSHPD desire following success of CABG program
– Elective PCI Pilot Programs
– Counties creating STEMI coordinating center models
• Washington State Department of Health

Analytic and Reporting Services
• Blue Cross Blue Shield Association
• HCA Mountain Star Division
• United Healthcare
• WellPoint (Q-HIP, QP3, and CSC programs)
• West Virginia Medical Institute (for WV and PA
mandates)

Acute Coronary Syndromes
Registry
• 325 participants
• Over 55,000 records
• No charge
• Funding provided by
– Genentech
– Bristol-Myers
Squibb/Sanofi Partnership
– Schering Plough
Corporation
AHA GWTG-CAD Merger to ACTION 2009

Purpose of the ACTION Registry
• A national surveillance system
– Assess characteristics, treatments, and outcomes of patients
hospitalized with ACS
– Focusing on high risk patients with STEMI and NSTEMI
• Optimize outcomes and management of ACS patients
– Implement evidence-based guideline recommendations in
clinical practice
• Facilitate efforts to improve quality & safety of ACS care
• Investigate novel quality improvement methods

The CARE Registry ®
A hospital-wide data collection tool for all carotid
revascularization procedures:
Carotid artery stent (CAS)
Carotid endarterectomy (CEA)
Objectively elements of care for both CAS or CEA
Meets reimbursement requirements for CMS
Provides national benchmarks for quality
improvement

Benefits of Enrolling with
CARE Registry ®
• Proven track record
• National in scope
• Applies to both carotid surgery and stenting
• Receive quarterly benchmarking information
– Patient specific
– Provider specific
– Institution specific
• Free online data collection tool
• Online data submission

How Do Clinical Registries Impact Practice?
1. How do I, or my facility, measure up?
(a.k.a. benchmarking)
2. Registries are a resource to answer
practical “real world” questions that
impact your everyday practice.
3. Registries are tool to help you and your
facility improve.

The NCDR Dashboard Report

Advantages of a Registry
• Standard data definitions (comparing apples to apples)
• Data audit program - An NCDR feature
• Provides data that are
– Relevant, Credible, Timely, Actionable
• Help facilities meet consumer, payer, and
regulator demands for reporting and quality care
• Counts for ABIM maintenance of certification
It’s All About Improving QUALITY!

How Do Clinical Registries Impact My
Practice?
1. How do I, or my facility, measure up?
(a.k.a. benchmarking)
2. Registries are a resource to answer
practical “real world” questions that
impact your everyday practice.
3. Registries are tool to help you and your
facility improve.

Answers Important Questions: Are we doing better?
Percentage of Primary PCI with D2B

Risk of Local Adverse Effects
Following Cardiac Catheterization
by Hemostasis Device and Gender
A Report from the NCDR in
Partnership 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

Registries as a Data Resource
• Other questions addressed by NCDR data
– DES/BMS utilization rates & stents/procedure
– Hospital volume and PCI mortality
– PCI outcome in patients > 85 years
– Safety of PCI without on-site surgical
backup
• Future questions to be addresses
– Optimal duration of clopidogrel (prasugrel)
• CODA- and 3P CODA-DES
– AHRQ/FDA Long-term Outcome of
Coronary Stents Study

Trends in DES vs. BMS Use for PCI for NSTEMI
%
100
90
80
70
60
50
DES Debate Begins
40
30
FDA Advisory Panel
DES
BMS
20
10
0
Q1 06 Q2 06 Q3 06 Q4 06 Q1 07 Q2 07 Q3 07 Q4 07

Hospital PCI Volume and In-Hospital Mortality
ACC-NCDR® 2001-2004
Hospital PCI
Volume (pts)
STEMI Non-STEMI Elective
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%
Zhang et al Circulation 2005 Suppl II;112:792.
(Odds Ratio, 95% CI)

PCI without Surgery On Site
Percutaneous Coronary Interventions
in Facilities
without On-Site Cardiac Surgery:
A Report from the National
Cardiovascular Data Registry (NCDR)
ACC/SCAI – i2 Summit
Late Breaking Clinical Trials
March 29, 2008

PCI without Surgery On Site
Study Population
NCDR CathPCI Registry
Consecutive PCI cases
January 1, 2004 to March 30, 2006
308,161 patients
465 centers
OFF-SITE Surgery Back-Up
9,029 patients
61 centers
ON-SITE Surgery Back-up
299,132 patients
404 centers

Risk Adjusted Outcomes
Odds Ratio (OR): outcomes for patients at On-Site (vs. Off-Site) facilities
adjusting for site correlations and potential confounding variables

PCI without Surgery On Site
Conclusions
• Off-Site PCI centers participating in the NCDR
are well organized with good logistical plans:
‣ Dedicated staff and facilities.
‣ Travel time, distances, and modality of transport are
appropriate for timely transfer to the off-site surgery
center.
‣ 92% provide 24/7 coverage.
‣ All sites are committed to provide primary PCI for
STEMI.

PCI without Surgery On Site
Conclusions
• Compared to On-Site PCI centers, Off-Site PCI
programs participating in the NCDR:
‣ Have smaller bed capacities.
‣ Are predominantly located in rural and suburban areas.
‣ Have lower annual PCI volume.
‣ Treat a higher percentage of patients who present with
subsets of MI (STEMI and NSTEMI).
‣ Have better reperfusion times in primary PCI.

Conclusions
• Compared to On-Site PCI centers, Off-Site PCI
programs have similar observed:
‣ Procedure success
‣ Morbidity
‣ Emergency surgery rates
‣ Mortality in cases that require emergency surgery
• The risk-adjusted mortality rate in Off-Site
facilities was comparable to those PCI centers
that have cardiac surgery on-site.

Implications
• The safety and effectiveness of Off-Site PCI
programs is a very important issue which
requires ongoing evidence-based assessment.
• The results of this study should not be used to
encourage the expansion of more Off-Site PCI
programs, rather it should confirm the
appropriateness of an Off-Site strategy for
programs that have made a commitment to
excellence in organization and logistics.

The Future is Now !!
CODA
Clopidogrel Optimal Duration Dual Anti-Platelet
Therapy- and 3-arm Prasugrel Clopidogrel Optimal
Duration Anti-Platelet Therapy after DES
Study Goal
Examine the role of dual Clopidogrel & aspirin and,
possibly, the role of Prasugrel & aspirin antiplatelet
therapy as a class effect across all DES platforms.
- NCDR Patient Recruitment Strategy

•DES & Extended Dual Antiplatelet Therapy:
What It Would Take: Collaboration: CODA-DES
• Regulatory
• FDA:
– CDER
– CDRH
– Off Comm
• E.U.
– Austria
– U.K.
– Sweden
• MHLW/PMDA
• Japan
• Academia
• Industry
• Duke
• BSCI
• Harvard
• Medtronic
• Cleveland •NCDR
• Abbott
Clinic
•
•Hospitals,
Cordis/J&J
• Columbia
• Eli Lilly
• U of NM
(Daichi)
• Wash Hrt Ctr
• Sanofi
• London School
• BMS
of Hyg & Trop
Med
• CVPath
•Physicians and Patientss
• Societies
• ACC
• SCAI
• ESC
• Federal
• NIH
• AHRQ

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

How Do Clinical Registries Impact My
Practice?
1. How do I, or my facility, measure up?
(a.k.a. benchmarking)
2. Registries are a resource to answer
practical “real world” questions that
impact your everyday practice.
3. Registries are tool to help you and your
facility improve.

Benchmarking: Primary PCI %

What Are Our Opportunities for Improvement?
Your hospital vs. the nation

The Future is Now
• Episodic in-Hospital Registries
– Assess In-hospital procedural complications/outcomes
TO:
• Longitudinal Registries allowing:
– Evaluation of clinical outcomes long-term
– Develop “disease oriented” Registries through linkage
with relevant Registries
– Outcomes assessments by varying treatment
strategies
– Ability for post-market device and drug surveillance

CMS- Yale- NCDR- ACC
Public Performance Measure Development
• Initial effort - NCDR CathPCI outcomes measures
– 30 day mortality following PCI
– 30 day readmission following PCI
• Linkage with CMS claims data for 30 day
longitudinal assessment
– Probabilistic Matching –unique patient admission by
hospital, admission date, age, gender
– HIPAA Compliant

NCDR Data Merging Partnerships
• Society of Thoracic Surgery
– Opportunity to merge PCI and CABG Databases !!!
– Better understanding practice patterns and longitudinal
outcomes
– Cross match patients with CMS data
– Cross match patients with Health Plans
• Wellpoint, Aetna, BCBS, UnitedHealthcare:
– Hospital, longitudinal, and pharmacy data
– Funded Longitudinal projects- Symptoms/QAL via SAQ

Six-Fold Geographic Variations in Age-Adjusted Coronary
Interventional Procedure Rates
Redding
Median = 8 / 1000
Range = 3 - 20
Wennberg, D. The Dartmouth Atlas of Cardiovascular Health Care 1999

64 Slice
Coronary CT

APPROPRIATENESS CRITERIA
• SPECT-MPI
• CCT/MRI
• TTE/TEEchocardiography
• Stress Echocardiography Fall 2007
• Coronary Revasc: PCI/CABG – Summer 2008
• Implementation of AC Pilot(s) Spring 2008
• CV imaging Cross Modality Appropriateness 2008

Future Challenges for National Registries
• Use of Registries for:
Public Reporting & Physician-level Reporting
– Validity of the Performance Measure reported
• Risk of the use other important but not “valid”
performance metrics or utilization data
– Accuracy
– Transparency
– Attribution
– Minimize negative unintended consequences

Future Challenges for National Registries
• Use of Registries for:
Public Reporting & Physician-level Reporting
We need systematic change designed to engage
physicians and track scientific and meaningful
measures:
1. Pay for Participation
2. Test the Performance Measures
3. Baseline Reporting
4. Valid Performance Measurement

Future Challenges for National Registries
• Achieve data standardization
• Streamline data collection-100% EHR integration
• Unique Patient identifier – Legislative Approach
• Linkage of relevant Registries
• Longitudinal strategies – develop viable business
cases
• GOAL: Convert procedural or episodic
hospital based Registries to “disease state”
patient-centric registries

Can’t wait to stop wearing these
red dresses once
George’s Presidency is over !!
Love that
new CV
Technology!
I thought
I was going to meet
Obama !