I mplantable C ardioverter D efibrillator: Overview of the NCDR Data Methodology

1. Implantable Cardioverter Defibrillator: Overview of the NCDR Data Methodology Christie Lang, RN, MSN Associate Director, ICD Registry American College of Cardiology Heart Rhythm Society Conference San Francisco, California May 15, 2008

2. Objectives • Review the development process of an NCDR Registry Product • Understand NCDR committee structures • Provide update regarding V2.0 Leads and Peds.

3. National Cardiovascular Data Registry • NCDR is initiative of the American College of Cardiology with partnerning support from many societies, for the ICD Registry: Heart Rhythm Society. • NCDR mission is to improve the quality of CV patient care by providing information, knowledge and tools, implementing quality initiatives; and supporting research that improves patient care and outcomes.

4. Uses of NCDR Data Registries • Quality Improvement • Measure/manage individual patient care • Study, develop and monitor care processes • Track outcomes of care. • Assess hospital and provider performance • Public Reporting • Quality-base payment • Certification & privileging, meet regulatory needs • Post Market Surveillance & Clinical Trials • Influence Clinical Practice Guidelines

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

6. Governance: NCDR Management Board • Each NCDR Registry is governed by NCDR’s Management Board and a committee structure that provide oversight and direction dedicated to its mission. • NCDR Management Board provides oversight and direction for NCDR activities, which include: • Accountability for financial performance, • Accountability for the quality of the Registry products and services. • Review and approval of Registry policies and strategic and operational plans, • Advocate, promote and influence key groups regarding the Registry’s activities; and • Set the high level agenda for the NCDR within the ACC community.

7. Committee Structure for each Registry The ICD Steering Committee shall provide scientific and clinical support to the development of the National ICD Registry. Steering Committee • Their tasks include the following: • Identify and approve list of quality indicators reported to participating institutions as well as CMS. • Identify data elements /definitions needed to calculate selected quality indicators and enhance the utility of the registry. • Determine appropriate report content and display format. • Provide guidance in developing content for training manuals. • Assist in providing relevant and consistent answers to user questions on data elements. Research & Publications Clinical Supp.Team

8. Governance: ICD Steering Committee The Steering Committee consists of a chair and 6-8 members including 2 ACC representatives, 2 HRS representatives, and one biostatistician specializing in cardiovascular care. • Stephen Hammill, MD, FHRS Chair 2007-2010 • Ralph Brindis, MD, MPH, FACC Member 2007-2010 • Alan Kadish, MD, FACC Member 2007-2010 • Mark Kremers, MD, FACC Member 2007-2010 • Bruce Lindsay, MD, FACC Member 2007-2010 • Michael Mirro, MD, FACC Member 2007-2010 • Martha Radford, MD, FACC Member 2007-2010 • Lynne Warner Stevenson, MD, FACC Member 2007-2010 • Joel Harder, MBA Liason:HRS 2007-2010 • Christine Lang, RN, MSN Liason:ACC 2007-2010

9. It Takes a Team!How many people are involved prior to an NCDR Registry product launch? Staff Staff CMO External Peer reviewers α-testers CSO Working Group Β-testers Registry Steering Committee Science oversight Committee Vendors Data Set Registry Product Launch

10. Each Registry develops a Charter that provides: • Purpose • Business Case • Project Overview • Goals and Objectives • Budget • Stakeholder Identification • Milestone Schedule • Project Assumptions • Project Constraints • Risks • Source Documents • Document Version History ICD Registry V1.08 Product Development Launch Charter Development Scientific Development Testing Tool Release Technical Development Maintenance Alpha Pilot IT Application Development & Testing

11. Scientific Development Scientific Development During Scientific Development Phase: • Steering Committee reviews list of key outcomes measures, clinical questions, etc to be reported: • ICD Registry was developed as part of CED by CMS to determine if patients receiving ICDs in the general population (“real world”) were comparable to patients enrolled in the randomized clinical trials of ICD therapy? • Specifically were the Patients, hospitals, indications, complications, and outcomes comparable to the studies MEASUREMENT IS KEY!

12. Scientific Development Scientific Development: Data Elements • Based on Hypothesis and Executive Summary Metrics establish preliminary list of data elements for registry inclusion • Use existing Clinical Data Standards. ICD Registry data elements are derived from ACC/AHA Electrophysiology Data Standards. • Review clinical trials, practice guidelines, performance measures, existing registries • Include fields for patient, device, facility and provider information, disease process.

13. ICD Registry Key Outcomes Measures:Incidence of Lead Dislodgement Scientific Development

14. Scientific Development Scientific Development • Dataset review, recommendations and approval: • Alpha testers • Steering Committee • Science Oversite Committee • Chief Medical Officer • Chief Science Officer

15. ICD Registry V1.08 Product Development Timeline Launch Charter Development Scientific Development Testing Technical Development Tool Release Maintenance Alpha Pilot IT Application Development & Testing

16. Technical Development Technical Development: Data Collection Tool • Map dataset against current NCDR registries for consistency of key core data elements • Format data elements in consistent sections • Patient demographic • History/risk factors • ICD Procedural information • Medications • Device • Adverse Events • Discharge • Technical Specifications created

17. Technical Development Technical Development – data dictionary

18. Online data collection tool features include: • Access from any web browser • Submit data to the NCDR™ • Data completeness reminders

19. Hospital collects and submits to DQR Successfully submitted data is analyzed Data is pooled for many uses Algorithms are used to combine data for participants’ reports and other uses Data is returned to Hospital as an Outcome Report Data Collection

20. ICD Registry V1.08 Product Development Timeline Launch Charter Development Scientific Development Testing Technical Development Tool Release Maintenance Alpha Pilot IT Application Development & Testing

21. Testing Testing Feasibility Check • Alpha Testing • Pilot testing of the form • Assessing flow of form in practice • Feasibility of data collection • Comprehension of data elements and definitions in practice • Beta Testing • Vendor certification Usability Check Consistency Check

22. ICD Registry V1.08 Product Development Timeline Launch Charter Development Scientific Development Testing Technical Development Tool Release Maintenance Alpha Pilot IT Application Development & Testing

23. Tool Release Release • Training and Roll out needed: Webinars, Training Manuals, FAQ’s developed. • Client and Contract support for Participants. • Software Vendors go thru intensive certification process. • Medications and devices tables are up to date and subject for review as needed

24. ICD Registry V1.08 Development Timeline Launch Charter Development Scientific Development Testing Maintenance Technical Development Tool Release Alpha Pilot IT Application Development & Testing

25. Maintenance Maintenance Phase- Evaluation • Quarterly Outcome Reports • Participant FAQ’s for clarification • Feedback from Committees • Steering Committee • Research and Publications Committee • Metric change • Literature Review • Guideline Recommendations Is it Time for a Revision?

26. Enhancements needed for V 1.08 • Specific data element oversights • Long QT, HCM etc • Pulse generator focused • No lead information except CS lead placement • Medicare primary prevention focus • Secondary prevention, non-Medicare • Pediatric

27. Coming Soon!Version 2.0: Peds and Leads • The ICD Registry Working Group met bi-weekly for the past year to revise the data collection form. • May 07: Working Group met with the FDA to begin discussion to incorporate Leads. • November 07 at AHA ICD Registry Working group met with PACES (Pediatric and Congenital Electrophysiology Society ) and the FDA to incorporate Pediatrics and Leads in to the ICD Registry. • Version 2.0 launch scheduled mid 2009.

28. Coming Soon!Version 2.0: Peds and Leads • Includespediatric patients receiving ICDs • Data will provide insight on pediatric SCD and ICD impact • Adding Leads will clarify the benefits, risks and performance of this technology in adults and pediatric patients.

29. Version 2.0: Leads and Pediatrics Data to be collected will include: • Atrial, ventricular, defibrillator, and left ventricular leads at the time of implantation, revison, replacement and removal. • This will improve lead surveillance following implantation. • Lead ID • Lead Data • Lead Location • Lead Placement Issues • Lead Function Issues • Lead Integrity Issues

30. Maintenance Maintenance Phase- Audit • The purpose of the Data Quality Program is to ensure that data submitted to the NCDR are complete, consistent, and accurate ultimately to improve the overall quality of the Registry. • For a participant’s data submission to be included in national and peer group benchmarks, the submission must pass all composite category inclusion thresholds of completeness established in the threshold reports. • This report presents the threshold results for all core elements, as well as the number of unique records, % valid and invalid values, as well as missing values. • Inclusion threshold criteria were chosen for their clinical and structural pertinence.

31. Maintenance Maintenance Phase- Audit • Onsite Auditing will begin 2008. • 10% Hospitals will be randomly selected for the audit to compare the data entered into the Registry with the original patient data in the hospital record system. • Also, auditing will include selected hospitals where the data is inconsistent. • Examples of inconsistent data will include hospitals reporting no complications or reporting an MD as board certified in EP who is not listed with the ABIM • Each hospital will receive a confidential audit report which displays their audit score and individual accuracy for each element.

32. Take Home Message • Process is long, thorough, but 100% guided by science. • Incredible teamwork needed for ultimate success. • Your feedback and involvement is the key to its success!

33. THANK YOU