1. CP1262561-1 CARE Registry Insights to the Future

2. High Risk for CEA SIR National Coverage Decision Post-Procedure LOS Hypertension AANS and CNS Audit Software Vendors Site Profile CAPTURE FAQs Institutional Repositories ARCHeR Symptomatic CMS Participant Training Insurance Payors Submitting Data Anti-Platelet Therapy Carotid Stenting Partners Carotid Duplex Ultrasound Follow-up ACC Institutional Reports NASCET Trial Arterial Access Closure Method Stroke FDA Search Engines and Research EVA-3s Trial Carotid Endarterectomy Organization of Data Executive Summary Embolic Protection Device SCAI User Interface Design SVMB Proposed Coverage Decision Transient Ischemic Attack AAN What’s important RIGHT NOW?

3. We cannot move forward without first knowing our past ….

4. Carotid Stenting Unique programmatic issues Why is this procedure different from all other procedures? Organ system and Disease stateOrgan system and Disease state –Unique anatomy, pathol, access, response to intervention ProcedureProcedure –New skill sets and different equipment –Unique access considerations –High risk; no room for error…Little errors cause a lot of hurt –Must be “on” all the time…never let guard down…

5. Carotid Stenting Unique programmatic issues (cont.) Milieu –Multidisciplinary disease –many specialties traditionally involved and have “stake” –unprecedented level of peer review and scrutiny –unique opportunity to set quality standards and benchmarks which cross specialty lines

6. CMS Coverage Decision March 2005 – New coverage decision released CMS agreed: –CAS with embolic protection is reasonable & necessary for certain populations of symptomatic and asymptomatic patients –Must use FDA approved devices –Covered under Category B IDE clinical trials and post- approval studies

7. March 2005 Medical Societies Unite AAN AANS/CNS ACC ACR ASITN ASNR SCAI SIR SVMB SVS In March 2005 stakeholder organizations met to discuss carotid stentingIn March 2005 stakeholder organizations met to discuss carotid stenting All agreed to support the development of standardized data elements and definitions that would be used by Carotid RegistriesAll agreed to support the development of standardized data elements and definitions that would be used by Carotid Registries

8. May 2005 Created a Definition Workgroup Workgroup Charge Identify key questions to guide development of data elements and definitions Create a standard set of elements and definitions

9. May – December 2005 Evidenced-Based Definitions The Workgroup Reviewed Clinical trials data elements CMS coverage decision Other occlusive disease registries Clinical literature

10. Dec. 2005 Type or Data Included Patient demographics (e.g. age, race) Patient identification – links patient records across data tables Clinical risk factors Procedural description Outcomes reporting Performance measurement Risk Adjustment – Mortality/Adverse Outcomes Health Services Research Follow-up

11. Jan – May 2005 CEA Added Workgroup recognized the value of being able to compare Carotid Stent and CEA outcomes

12. Aug. 2006 Alpha Test Review 8 Participants reviewed the data elements, data collection form, and definitions

13. Aug. 2006 Alpha Test Review 8 Participants reviewed the data elements, data collection form, and definitions The Purpose of the Alpha Test “ Feasibility Check” Assess flow of form Identify gaps or difficulties in data collection Comprehension of data elements and definitions in practice Who’s collecting data?

14. The CARE Registry was Launched September 2006 !!

17. Moving Forward Meeting with CMS, FDA, Industry Stakeholders and Competitors –Focusing on Data Harmonization –Meet CMS-recommended benchmarks to Determine appropriateness Reimbursement Measure for Data Consistency and Completeness Begin using Outcomes Data for future research “Make Success Measurable”

18. Data Harmonization Guiding Principles: 1.Data harmonization is a process not a project and should begin as early as possible. 2.Identify key internal and external stakeholders. 3.Engage existing and potential stakeholders. 4.Understand and agree on scope of initiative. 5.Define requirements. 6.Review best practices. 7.Select a methodology and appropriate tools. 8.Identify relevant information exchanges and the data systems that support them. 9.Concepts and definitions must be universally accepted within the Community of Practice. 10.Publish work product so it can be consumed by practitioners and technologists.

19. Thank You Questions?

20. For Additional Information NCDR Website:www.ncdr.com Service Center:(800) 257-4737 Monday –Friday, 8:00 am – 5:00 pm ET E-mail:ncdr@acc.org Fax:(202) 375-6843 Mailing address:2400 N Street NW Washington, DC 20037