Implantable

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• 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
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Objectives

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

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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.

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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

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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
IC3 Steering Committee
TAKE ACTION Planning Work Group
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 nations CV Outcomes experts
involved
CARE Registry
Includes 30day outcomes
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Governance NCDR Management Board

• Each NCDR Registry is governed by NCDRs
  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 Registrys activities and
• Set the high level agenda for the NCDR within the
  ACC community.

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The ICD Steering Committee shall provide
scientific and clinical support to the
development of the National ICD Registry.
Committee Structure for each Registry
Steering Committee
Research Publications
Clinical Supp.Team

• 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.

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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 LiasonHRS 2007-2010
• Christine Lang, RN, MSN LiasonACC 2007-2010
  

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It Takes a Team!How many people are involved
prior to an NCDR Registry product launch?
Staff
Staff
CMO
External Peer reviewers
a-testers
CSO
Working Group
?-testers
Registry Steering Committee
Science oversight Committee
Vendors
Data Set
Registry Product
Launch
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• 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
Scientific Development
Testing
Tool Release
Charter Development
Technical Development
Maintenance
Alpha Pilot
IT Application Development Testing
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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!
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Scientific Development Data Elements
Scientific Development

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

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ICD Registry Key Outcomes MeasuresIncidence of
Lead Dislodgement
Scientific Development
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Scientific Development
Scientific Development

• Dataset review, recommendations and approval
• Alpha testers
• Steering Committee
• Science Oversite Committee
• Chief Medical Officer
• Chief Science Officer

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

• 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

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Technical Development data dictionary
Technical Development
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• Online data collection tool features include
• Access from any web browser
• Submit data to the NCDR
• Data completeness reminders

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Data Collection

• 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

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

• Training and Roll out needed Webinars, Training
  Manuals, FAQs 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

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ICD Registry V1.08 Development Timeline
Launch
Scientific Development
Testing
Maintenance
Charter Development
Technical Development
Tool Release
Alpha Pilot
IT Application Development Testing
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Maintenance Phase- Evaluation
Maintenance

• Quarterly Outcome Reports
• Participant FAQs for clarification
• Feedback from Committees
• Steering Committee
• Research and Publications Committee
• Metric change
• Literature Review
• Guideline Recommendations

Is it Time for a Revision?
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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

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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.

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Coming Soon!Version 2.0 Peds and Leads

• Includes pediatric 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.

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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

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Maintenance Phase- Audit
Maintenance

• 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 participants 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.

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Maintenance Phase- Audit
Maintenance

• 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.

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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!

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THANK YOU