1. Ralph G. Brindis, MD, FACC Chief Medical Officer ACC-NCDR November 4, 2007 N C D R N ational C ardiovascular D ata R egistry 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

2. 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

3. 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.

4. NCDR is… N ational C ardioVascular D ata R egistry 1998…..20042005200620072008beyond CathPCIRegistry ICDRegistry CARERegistry ACTIONRegistry IC3 CAD Imaging Registry HF Registry PracMgt Registry PAD Registry EP Registry Ped. Registry Congenital Registry Building a true… ICD Long Achieve

5. Registry ProjectsRegistriesQI Projects NCDR Management Board NCDR Operations Leadership Team Data Safety Monitoring Board Scientific Oversight Committee Research & Publications Clinical Support.Team SteeringCommittee CathPC I Registr y CARE Registr y ICD Registr y Committee structure for each registry Includes 30day outcomes ACTIO N Registr y IC 3 Program Steering Committee ACHIEVE Registry Steering Committee ICD Longitudinal Program Steering Committee Take ACTION Campaign Planning Work Group NCDR-D2B Project Managed by ACTION and CathPCI Steering Committees ambulatory longitudinal QualityKIT/CathKIT TBD QI Subcommittee Version 10/29/07 Advisory Council Industry Federal Health Plans Patients

6. Executive Summary Page

7. CathPCI™ Report: Executive Summary Median 75 Pctl 25 Pctl 90 Pctl 10 Pctl Your Hospital Best Practice Indicator Detail Line Number Rank percentile Rank Your Hospital

8. Registry/QI >985 hospitals 6 million patient records 2 millions PCI records Online data entry tool Support D2B Alliance Analytic Reporting Services States – MA, OH, WV, ?CT, ?NJ Payers – United, BCBSA, WellPoint Research and Publications DCRI analytic center Over 100 publications

9. 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

10. Registry 235 Participants > 3,000 patient records Data entry tool CMS data requirement Research Analysis for FDA Discussion with industry - PMS

11. 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

12. Concept Outcomes Clinical Trials Guidelines Performance Indicators Performance Indicators PerformancePerformance QUALITY NCDR: ICD, ACTION, CARE, CathPCI & STS NCDR: ICD, ACTION, CARE, CathPCI & STS The Cycle of Clinical Therapeutic Effectiveness

13. Benchmarking: Primary PCI % <90 Minutes

14. 2004 STEMI ACC/AHA Guideline Update & JCAHO Core Measure D2B Alliance Launch

15. ACC-Quality/CathKIT™ CQI Tutorial Meeting Standards Reporting & Outcomes Implementing CQI

17. Hospital PCI Volume and In-Hospital Mortality ACC-NCDR ® 2001-2004 Hospital PCI STEMI Non-STEMI Elective Volume (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 Elective Volume (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) Zhang et al Circulation 2005 Suppl II;112:792.

18. Performing Percutaneous Coronary Interventions at Facilities Without On-Site Cardiac Surgical Backup is Increasing A Report From The American College of Cardiology - National Cardiovascular Data Registry Dehmer GJ, et.al. Am J Cardiol 2007;99:329-332.

19. Proportion of Urgent PCIs with and without On-site Surgical Back-up Jan 2001 Dec 2004 Calendar Quarter

20. Proportion of Elective PCIs with and without On-site Surgical Backup Jan 2001 Dec 2004 Calendar Quarter

21. 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

22. 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

23. 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

24. Improving Continuous Cardiac Care Office-Based Registry

25. 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.

26. 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

27. Measuring CAD Care Patient with stable angina Onset of Acute Coronary Syndrome Post-Hospitalization: Risk factor modification Cardiac rehabilitation D/C PCI/CABG Admit AMI Care NCDR ACTION Cath/PCI IC 3 ACTION Follow-up

28. The IC 3 Registry Pt presents for visit, reports med changes Vitals, health status assessed Physicia n Visit & Rx Data entered and Clinic Visit Form Generated Treatment plan Data entered Patient Letter & Visit Summary dispensed Visit Summary sent to other care providers Data Entered through NCDR IC 3

29. 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

30. 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

31. 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

32. ACC’s Appropriateness Criteria: SPECT-MPI Cardiac CT Cardiac MRI Echo: TTE/TEE & Stress Coronary Revascularization: PCI/CABG

34. 64 Slice Coronary CT 64 Slice Coronary CT

35. Tools for Achieving Quality in Imaging Patient Test selection Image acquisition Image interpretation Results communication Better patient care ACC-Duke Think Tank 2006 JACC 2006 48: 2141 Registries Research Appropriateness criteria Benchmarking Provider education Lab accreditation Technologist cert. Lab accreditation Physician training Physician competency Key data elements Uniform structured reports Timeliness standards

36. Pilot Study: Evaluation of Appropriateness of SPECT MPI The American College of Cardiology The American Society of Nuclear Cardiology NCDR

37. 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

38. SPECT MPI Appropriateness Criteria Implementation Program  Paper 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

39. \ Appropriateness Based on Physician Ordering

40. Anderson et al. Circulation 2005; 112:2786 Indications Relationship between Procedure Relationship between Procedure Indications & Outcomes of PCI: ACC/AHA Guidelines ACC-NCDR

41. Anderson et al. Circulation 2005; 112:2786 Adverse Events Relationship between Procedure Indications and Outcomes of PCI by ACC/AHA Guidelines ACC-NCDR

42. 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

43. 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

44. 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

45. 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

46. 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

47. 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