Title: Using the ICD Registry to Evaluate Practice Patterns and Improve Quality Overview of the Development of the ICD Registry
1Using 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
2ICD 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
3ICD 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
4National 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
-
5ICD 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
6ICD 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
8CEDCoverage 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
9ICD 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
10ICD RegistryDeveloping the Baseline Registry
10/27/05 CMS selected the ICD Registry
developed by ACC and HRS based on the NCDR
CP1262561-5
11ICD 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
12ICD 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
13ICD 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)
14Why 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
15Potential 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
16Potential 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
17ICD 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
18National 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
19National 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
20National 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
21National 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
22Are payors and providers adversaries or
partners?
23State and Federal Lawmakers
Patients And Families
Hospital and Physician Profiling
Health Plans
CMS
Insurers
State Departments Of Health
24Administrative data versus Clinical data
25CP1265452-1
26State Regulators Are Using the Cath NCDR
Regulation Passed Regulation Pending
MA
MI
NJ
IL
O
IA
PA
MD
CA
WV
AL
FL
27Payers 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
28Developing the Longitudinal Registryto Answer
the CED Questions
CP1262561-6
29It 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
30CED Questions
- EF 31-15
- Non-ischemic cardiomyopathy lt9 months
- Class IV CRT-D patients
31Longitudinal 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
32Longitudinal 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
33ICD 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
34ICD 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
35ICD 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
36ICD 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
37Why 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(No Transcript)