Pediatric ICD Registry Next Steps

1
Pediatric ICD RegistryNext Steps

• Ralph Brindis, MD, MPH, ACC
• Stephen Hammill, MD, HRS
• Kathleen Hewitt, RN, MSN, CPHQ
• Christine Lang, RN, MSN

2
What is the NCDR?

• 17 years in Evolution
• Benchmarks and Quality Improvement
• Standardized, evidence-based data collection
• Quarterly benchmark reports
• Performance Measurement Tool
• Supports P4P and Pay for Reporting Programs
• Platform for Outcomes Research
• Solution of Post-Market Surveillance

3
NCDR Management Board
Advisory Council Industry Federal Health
Plans Patients
NCDR Operations Leadership Team
Scientific Oversight Committee
Data Safety Monitoring Board
Registry Projects
Registries
QI Projects
ambulatory
Committee structure for each registry
ACTION Registry
IC3 Program Steering Committee
Take ACTION Campaign Planning Work Group
Steering Committee
longitudinal
CathPCI Registry
ACHIEVE Registry Steering Committee
NCDR-D2B Project Managed by ACTION and CathPCI
Steering Committees
Research Publications
longitudinal
ICD Registry
Clinical Support.Team
ICD Longitudinal Program Steering Committee
QualityKIT/ CathKIT TBD
QI Subcommittee
CARE Registry
Includes 30day outcomes
Version 10/29/07
4
NCDR is
Ped. Registry
Achieve
Building a true
National CardioVascularDataRegistry
ICD Long
EP Registry
Imaging Registry
PracMgt Registry
Congenital Registry
PAD Registry
IC3 CAD
ACTION Registry
HF Registry
CARE Registry
CathPCI Registry
ICD Registry
1998.. 2004 2005 2006 2007 2008 beyond
5
Magnitude of SCA in the U.S.
167,366
Stroke3
SCA claims more lives each year than these other
diseases combined
450,000
SCA4
Lung Cancer2
157,400
40,600
Breast Cancer2
42,156
AIDS1
1 U.S. Census Bureau, Statistical Abstract of
the United States 2001. 2 American Cancer
Society, Inc., Surveillance Research, Cancer
Facts and Figures 2001. 3 2002 Heart and Stroke
Statistical Update, American Heart Association. 4
Zheng Z. Circulation. 20011042158-2163.
6
CMS (Medicare) Coverage for ICDs1990s

• Cardiac arrest due to VF, not due to a reversible
  cause (effective 1991)
• Spontaneous or induced VT, not associated with an
  acute MI or reversible cause (effective 1999)
• Familial conditions at high risk such as LQTS,
  HCM (effective 1999)

7
The results of SCD-HeFT and MADIT I-II indicate
that ICDs are effective for the primary
prevention of sudden death. What we dont know
is if the results reflect the ICD experience in
the real world outside the confines of the
controlled trials.

• What we dont know..

8
Expanded CMS Coverage for Primary Prevention ICDs
Registry Hypothesis

• Are the clinical characteristics, indications for
  ICD implantation, and in-hospital procedure
  related complications of the ICD Registry
  patients similar to those of patients involved in
  the primary prevention randomized trials
• (MADIT I-II, SCD-HeFT )?

9
ICD Data Reporting

• What will CMS do with the data?
• Data will be used to determine that services
  provided are reasonable and necessary.
• Address hypotheses related to patient
  characteristics, clinical indications, provider
  competency, complication variation across
  implanters, hospitals and device manufacturers.

10
CMS (Medicare) Coverage for ICDsExpanded
Coverage, 1/27/05

• Cardiac arrest due to VF, not due to a reversible
  cause (effective 1991)
• Spontaneous or induced VT, not associated with an
  acute MI or reversible cause (effective 1999)
• Familial conditions at high risk such as LQTS,
  HCM (effective 1999, (Registry required)

11
CMS (Medicare) Coverage for ICDsExpanded
Coverage, 1/27/05

• CAD, prior MI, EF 35 or less, inducible
  sustained VT (EP test and ICD implant gt4 weeks
  after MI, (Registry required)
• Documented prior MI, EF 30 or less (Registry
  required)
• IDCM, prior MI, Class II-III, EF 35 or less
  (Registry required)

12
CMS (Medicare) Coverage for ICDsExpanded
Coverage, 1/27/05

• Non-IDCM, gt3 months, Class II-III, EF 35 or less
  (Registry required)
• CRT candidates, Class IV
• (Registry required)

13

• Partnership with The Heart Rhythm Society which
  is the preeminent professional advocacy society
  for cardiac arrhythmia professionals and
  patients, and the primary information resource on
  heart rhythm disorders.
• HRS represents more than 4,200 specialists in
  cardiac pacing and electrophysiology in 78
  countries Its mission is to improve the care of
  patients by promoting research, education and
  optimal health care policies and standards.

14
CMS Expands ICD Coverage ICD Registry Mandated

• September, 2004
• Draft CMS Coverage Policy indicates interest in
  ICD Registry
• October, 2004
• CMS names Heart Rhythm Society to lead National
  ICD Registry Working Group. Working Group (ACC,
  HRS, HFSA, registry experts, private insurance
  co, device manufacturers, AHA) advises CMS on ICD
  Registry issues
• January, 2005
• CMS Announces and Implements new expanded ICD
  coverage policy with new mandated registry
  requirement (QNET)
• Why CMS required data submission?
• Clinical trials (MADIT I-II, SCD-HeFT etc)
  results were promising but not definitive.
• Additional data may allow CMS to broaden policy.

15
CMS Expands ICD Coverage ICD Registry Mandated

• May, 2005
• National ICD Registry Working Group submits
  recommendations to CMS
• June, 2005 NCDR ICD Registry Launches!
• October, 2005 CMS Announcement that ICD
  Registry sponsored by ACC/HRS will be the
  official ICD Registry replacing QNET
• April 30, 2006 QNET sunsets, ICD Registry
  becomes the sole data repository for hospitals
  across the US.

16

• Registry
• 1493 enrolled
• 200,580 patient records
• 74 are submitting all pts. premier
• 26 CMS limited
• Funding
• 2007 support from WellPoint
• Hospital fee 1,895
• Analytic Reporting Services
• In May UHC added ICD Registry participation for
  sites with EP Labs
• Discussions underway with BCBSA
• Provide data to CMS for reimbursement
• Research
• ICD Longitudinal Study TBD
• Funding Industry and Payors
• YALE CRO/Analytics
• Performing analysis for FDA

17
(No Transcript)
18

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

19
ICD Registry Operations Update

• Software Vendors ( indicates certified)
• Axis Clinical Software, Inc.
• Emageon (formerly Camtronics Medical Systems)
• Cedaron Medical, Inc.
• GE Healthcare
• Goodroe Healthcare Solutions, LLC
• Heartbase
• Intelligent Business Solutions
• LUMEDX
• Philips Medical Systems
• TenFold Corporation
• Velos, Inc.

20
The First ICD Outcomes Report Launched
21
The First ICD Outcomes Report Launched

• Each facility has a choice in which patients they
  submit to the NCDR.
• Each ICD Registry participant will receive two
  reportsan ICD Premier report and a CMS Limited
  report. These reports contain data on different
  populations of patients.

22
Complications Reported
23
Support

• Dedicated IT staff
• Dedicated Clinical staff
• Dedicated Customer Service staff
• Professionally-Driven

24
Training

• Annual User Group Meetings
• Annual Workshops
• Training Manual
• Webinars
• NCDR Online

25
Focus Towards Innovation and Improvement

• Streamline data collection continuum of care
  v2.0
• New online query tools
• Real-time reporting

26
Pediatric ICD Registry The Challenge

• Assess and understand the dynamic changes in the
  diagnosis, treatment, and outcomes of pediatric
  ICD patients who are at risk for sudden cardiac
  death and congenital heart disease.
• Provide a basis for measuring performance,
  designing quality improvement initiatives, and
  improving the outcomes of Pediatric ICD patients.

27
A Growing Need

• Information is limited on pediatric patients with
  or at risk for sudden cardiac death, particularly
  with respect to the use and outcomes of ICD
  procedures.
• Accumulation of pediatric data would allow for
  significant contributions to the knowledge and
  outcomes associated with pediatric sudden cardiac
  death.
• Collection of these data would facilitate
  performance measurement, benchmarking, and
  quality improvement efforts.

28
A Growing Need

• The rapid evolution in medical technology/procedur
  es and the continued growth of the adult
  population with congenital heart disease suggest
  that considerable knowledge may be gained from a
  broad assessment of the Pediatric ICD population.
• Significant need to characterize variability in
  procedures and impact on patient outcomes.

29
National Pediatric ICD Registry

• US registry of pediatric patients undergoing
  implantation of Implantable Cardioverter
  defibrillators.
• Prevalence
• Demographics
• Acute management
• Peri-procedural outcomes
• In-hospital outcomes

30
Registry Data

• A review of the ICD Registry Q1 2005 to Q4 2006
  data showed that there were 135 pediatric
  patients originally listed ( lt18 yr). Of the
  listed patients, 94 of those patients were key
  errors and 41 of those patients were in fact
  pediatric patients. Of note, the majority of
  Pediatric patients receiving ICDs are not entered
  into the ICD Registry at this time since they are
  not Medicare beneficiaries.
• Following are the ages for the correctly
  documented implanted pediatric ICDs in the
  Registry
• 9 years old (1)
• 10 years old (1)
• 11 years old (4)
• 12 years old (5)
• 13 years old (2)
• 14 years old (4)
• 15 years old (8)
• 16 years old (8)
• 17 years old (8)

31
Proposal

• Initial focus would include inpatient data
  collection for pediatric patients receiving ICDs
  for Primary or Secondary Prevention.
• At this time no longitudinal data would be
  collected.
• Inclusion of the pediatric population achieved by
  expanding current ICD Registry sites and a
  stand-alone pediatric ICD centers.

32
Proposal

• Multi-center registry that would be web-based,
  with simple data collection variables.
• Collection of data relating to a growing but
  poorly understood subset population of patients
  who benefit from ICD implantation procedures that
  have not been adequately controlled or measured
  from a quality perspective.
• To date, no registry has successfully collected
  sufficient data to provide reliable information
  relating to the broader pediatric population
  undergoing ICD implantation procedures or
  real-world procedural outcomes.

33
Proposal

• Estimated 120 dedicated pediatric care hospitals
  in the US, an additional 180 hospitals perform
  procedures for patients with CHD.
• ICD Registry Steering Committee continue to
  engage national thought leaders in Pediatric
  Cardiology and Electrophysiology (PACES) to
  provide guidance and facilitate recruitment of
  the leading Pediatric ICD centers in the US.
• Comprehensive communication and recruitment
  program will be developed to ensure rapid and
  successful recruitment of target hospitals.

34
In Conclusion

• ICD Registry Steering Committee requests feedback
  and endorsements to expand the scope .
• Purpose to assess prevalence, demographics,
  management, and outcomes of peds patients
  undergoing implantation for ICDs for sudden
  cardiac death.
• Initial focus to include inpatient data
  collection for Primary or Secondary Prevention.
  At this time no longitudinal data would be
  collected.
• Steering Committee members believe implementing
  will expand the NCDR registry network, and will
  significantly increase the ability to conduct
  outcomes research across the continuum of
  cardiovascular adult and pediatric patient care.

35
If I can ditch them by 4pm I can still play The
front nine!!
Do I always have to wear this Red Dress?
When do we get to go to Disney World?
36
Questions