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Using the ICD Registry to Evaluate Practice Patterns and Improve Quality Overview of the Development of the ICD Registry

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Title: Using the ICD Registry to Evaluate Practice Patterns and Improve Quality Overview of the Development of the ICD Registry


1
Using the ICD Registry to Evaluate Practice
Patterns and Improve QualityOverview of the
Development of the ICD Registry
Heart Rhythm 2008 San Francisco May 15,
2008 Stephen Hammill, MD
CP1262561-1
2
ICD RegistryHighlights to Date
  • 1,490 hospitals
  • gt260,000 implants (10,000/month)
  • 55 are primary prevention CMS patients
  • 88 of implants from hospitals entering all
    patients (1 and 2 prevention, all ages)
  • Version 2.0 in development
  • Longitudinal registry developed (CED)
  • Research and publications in progress

Getting to this pointand moving forward
CP1262561-2
3
ICD RegistryDeveloping the Baseline Registry
  • 9/28/04 CMS published proposed NCD
  • Following SCD-HeFT release
  • National data base proposed
  • HRS asked to chair the Working Group to develop
    the registry

CP1262561-3
4
National ICD Registry Working Group
  • HRS, chair ACC
  • HFSA AHA
  • Medtronic Biotronik
  • Guidant St Jude
  • BCBS NCDR
  • United HealthCare Aetna
  • Am Hlth Ins Plans AHRQ
  • FDA Am Hosp Assoc
  • CMS At large members

5
ICD RegistryDeveloping the Baseline Registry
  • 9/28/04 CMS published proposed NCD
  • Following SCD-HeFT release
  • National data base proposed
  • HRS asked to chair the Working Group to develop
    the registry
  • 11/22/04 Working Group recommendations sent to
    CMS
  • Purpose of the registry
  • Patients to be enrolled
  • Patient and device data elements to be collected
  • Defining providers as competent and qualified to
    implant ICDs

CP1262561-3
6
ICD RegistryDeveloping the Baseline Registry
  • 1/27/05 CMS published final NCD
  • Expanded ICD indications
  • CED process described
  • Data collection using QNet
  • Temporary data collection tool

CP1262561-4
7
What does CMS hope to gain from the
Registry?CMSs goal is to determine whether
primary prevention ICDs are appropriate for the
Medicare beneficiaries who meet the clinical
conditions identified in the agencies NCD of
1/27/05.Coverage with evidence development(CED)
Hammill, Phurrough, Brindis. HeartRhythm, 2006
8
CEDCoverage with evidence development Develop
evidence on what works best in clinical practice
. . . explicit, rapid, evidence based on a
process that is predictable with transparency . .
. to improve the knowledge base by which patients
and providers can make better treatment
decisions. Mark McClellan Administrator,
CMS 2/14/05 Conference call
9
ICD RegistryDeveloping the Baseline Registry
  • 1/27/05 CMS published final NCD
  • Expanded indications
  • CED process described
  • Data collection using QNet
  • Temporary data collection tool
  • 3/05 HRS asked to reconvene the Working Group
  • Define questions that should be answered
  • Define the core characteristics of a national
    clinical registry
  • 5/19/05 Recommendations sent to CMS

CP1262561-4
10
ICD RegistryDeveloping the Baseline Registry
10/27/05 CMS selected the ICD Registry
developed by ACC and HRS based on the NCDR
CP1262561-5
11
ICD RegistryDeveloping the Baseline Registry
  • 10/27/05 CMS selected the ICD Registry
    developed by ACC and HRS based on the NCDR
  • 1/1/06 All data submitted to ICD Registry QNet
    phased out 4/1/06
  • Hospitals encouraged to submit data on all
    patients
  • SCD-HeFT median age 60 yrs
  • Medicare median age 74 yrs

CP1262561-5
12
ICD RegistryDeveloping the Baseline Registry
  • 10/27/05 CMS selected the ICD Registry
    developed by ACC and HRS based on the NCDR
  • 1/1/06 All data submitted to ICD Registry QNet
    phased out 4/1/06
  • Hospitals encouraged to submit data on all
    patients
  • SCD-HeFT median age 60 yrs
  • Medicare median age 74 yrs
  • 4/07 Quarterly benchmarking reports sent to
    hospitals
  • Data Quality Reporting process
  • Random auditing

CP1262561-5
13
ICD Registry Data Quality Program
  • National Onsite Audit Program
  • Annual review
  • 10 random sample of eligible sites
  • Comparative analysis of audit findings and sites
    original data submission (MD training
    discrepancy, lack of complications, etc)

14
Why is Benchmarking Important to Hospitals?
  • Quarterly benchmarking compares a hospitals
    outcomes with hospitals of similar size and a
    national aggregate
  • Improved Patient Care
  • Meet State Regulations and Payer Requirements
  • Detect Inefficiencies
  • Improved resource utilization

15
Potential Benefits of the Registry
  • Reveal the degree to which clinicians are
    managing a disease in accordance with
    evidence-based medicine
  • Enable clinicians to compare their own outcomes
    with those of other MDs
  • Provide insights for clinical investigation
  • Highlight a products performance outside of
    clinical trial constraints

Hammill, Phurrough, Brindis. HeartRhythm, 2006
16
Potential Benefits of the Registry
  • Provide a detailed view of the morbidity,
    mortality, and resource utilization associated
    with a particular disease
  • Perform local hospital needs for QA and QI
  • Serve as a hospital and physician response to
    Pay for Performance initiatives of health plans

Hammill, Phurrough, Brindis. HeartRhythm, 2006
17
ICD RegistryA Quality Improvement Tool AHRQ
Observational registries can quickly accumulate
large amounts of data on real-world practice and
effectiveness of new treatments and procedures.
Physicians and hospitals can use these data to
further QI efforts at a local level and physician
associations can evaluate data to determine the
effectiveness of existing clinical guidelines.
Registries for Evaluating Patient Outcomes A
Users Guide. Agency for Health Care Research
and Quality
CP1262561-5
18
National ICD Registry 2006
Age (yr) 68 Male/female () 74/26 Race
() White 83 Black/African American 12 Hispanic
5 Asian 1 American Indian/Alaska Native
0.4 Native Hawaiian 0.2 Other 4
Hammill et al Heart Rhythm, 2007
CP1281777-3
19
National ICD Registry 2006
Total implants (no.) 206,604 Hypertension ()
74 Diabetes () 36 Chronic lung
disease () 22 Ischemic heart disease
() 66 Non-ischemic dilated
cardiomyopathy () 31 Hx of cardiac
arrest () 11 Hx of CHF, no. ()
77 NYHA class II-III () 81 QRS
duration (ms) 129 Ejection fraction ()
28
Hammill et al Heart Rhythm, 2007
CP1281777-2
20
National ICD Registry 2006
Total implants (no.) 108,341 Single chamber
ICD () 23 Dual chamber ICD ()
39 Biventricular ICD ()
38 Adverse procedure-related event ()
3.24 Death in laboratory
0.02 Cardiac perforation
0.07 Hematoma 0.99 Lead
dislodgement 0.97 Hemo/pneumothor
ax 0.54 Transient ischemic
attack/stroke 0.06 Other
0.61
Hammill et al Heart Rhythm, 2007
CP1281777-1
21
National ICD Registry 2006
3,899 implanting physicians 206,604 procedures
Implants performed
Physicians
Training category EP fellowship boards 51
77EP fellowship only 6
6 Surgery residency 11
2 HRS ICD Guidelines 17
9 None of the above 15
6
CP1281777-5
Hammill et al Heart Rhythm, 2007
22
Are payors and providers adversaries or
partners?
23
State and Federal Lawmakers
Patients And Families
Hospital and Physician Profiling
Health Plans
CMS
Insurers
State Departments Of Health
24
Administrative data versus Clinical data
25
CP1265452-1
26
State Regulators Are Using the Cath NCDR
Regulation Passed Regulation Pending
MA
MI
NJ
IL
O
IA
PA
MD
CA
WV
AL
FL
27
Payers and the ICD Registry
  • May 24, 2007 United Health Care, ACC and HRS
    announced an initiative that will improve patient
    care by expanding the collection and use of
    clinical outcomes data for heart rhythm devices
    by cardiac care facilities, cardiac surgeons,
    cardiologists, and other healthcare
    professionals
  • Hospitals seeking designation as a United Health
    Premium Cardiac Specialty Center will be required
    to submit data to the National ICD Registry

28
Developing the Longitudinal Registryto Answer
the CED Questions
CP1262561-6
29
It is particularly important that these factors
(ICD firing data and survival) be determined in
the actual population receiving ICDs, who are
older and present more comorbidities than
represented in the trial populations.
Fortunately, these key factors will be tracked in
the ICD Registry
Lynne Warner Stevenson, MD Circulation.
2006114101
30
CED Questions
  • EF 31-15
  • Non-ischemic cardiomyopathy lt9 months
  • Class IV CRT-D patients

31
Longitudinal RegistryStudy Design
  • Primary endpoint
  • First delivery of an appropriate ICD therapy
    (shock, ATP)
  • Secondary endpoint
  • Survival probability at 3 and 5 years
  • Death from CV cause
  • Total and rate of device therapies
  • Ratio of inappropriate to total device therapies

CP1262561-13
32
Longitudinal RegistryStudy Design
  • 350 randomly selected implanting MDs
  • 3,500 patients followed 3 years for events and 5
    years for survival
  • Based on 10 rate of appropriate therapy at 3
    years (15 at 3 years in SCD-HeFT)
  • Device therapy follow-up
  • Every 3 months for a minimum of 3 years
  • Adjudication process
  • Data combined with NDI and Medicare claims data

CP1262561-14
33
ICD RegistryVersion 2.0 Updating the Registry
  • Redefine the registry purpose, target audience
  • Enhance the data collection forms
  • Add leads -- implant, revision, replacement
  • Make the registry a performance reporting tool
    (Guidelines)
  • Post market surveillance (FDA Sentinel Network)
  • Coordinate with longitudinal data Medicare
    Claims Data, National Death Index

CP1262561-17
34
ICD RegistryResearch and Publications
  • Research requests are reviewed and prioritized
    by RP Subcommittee
  • 34 requests to date
  • ICD-Registry provides financial support for data
    analysis
  • Yale CORE assists with data analysis
  • 6 abstracts presented at AHA, 11/07
  • 5 manuscripts

CP1262561-20
35
ICD RegistryResearch and Publications
  • Sample research proposals
  • How do the baseline characteristics of patients
    receiving ICD therapy in the general population
    (real world) compare with the characteristics
    of patients enrolled in randomized clinical
    trials of ICD therapy?
  • Are patient outcomes such as morbidity and
    mortality affected by patient baseline clinical
    characteristics such as ejection fraction, QRS
    duration, NYHA class, gender, age, and race?

CP1262561-21
36
ICD RegistryResearch and Publications
  • Sample research proposals
  • What are the characteristics of the physicians
    implanting ICDs regarding training, experience,
    and volume and how does this relate to
    implantation outcomes?
  • Does age, race, and sex distribution of patients
    undergoing ICD implantation differ among
    different regions of the country and different
    size of hospitals?

CP1262561-22
37
Why a Registry?
  • Science tells us what we can doGuidelines what
    we should do and Registries what we are
    actually doing.
  • Lukas Kappenberger MD
  • HRS ICD Policy Conference
  • Washington DC, 9/16/05

38
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