A Proposal for the
IMACS
(ISHLT Mechanically Assisted Circulatory Support)
Registry
James K. Kirklin
April 2011
Historical Development of
ISHLT MCS Registries
• 2002-2006 First MCS Registry. Ill-fated
attempt to stage collection of tier 1
(demographics) and tier 2 (outcomes) data.
• Registry discontinued in 2006.
• 2005- consortium of ISHLT stakeholders in
MCS therapy asked me and colleagues at
UAB to lead response to NIH RFP for US
database in MCS.
• Result- INTERMACS, which earlier this year
was awarded a 5 year renewal.
Historical Development of
ISHLT MCS Registries
• Subsequent efforts for an international
MCS database focused on the Tx Registry
model (collect incompletely validated data
from all possible centers)
• Efforts within ISHLT unsuccessful in a
landscape of polarized views about US vs
European location of database. No traction
from EuroMacs or EuroTransplant in
establishing a viable database.
• 2007 – Revised ISHLT mission statement
established MCS at equal priority level as
Hrt and Lung Tx
Historical Development of
ISHLT MCS Registries
• Dec, 2010 – the Board reaffirmed its interest in
establishing an MCS registry to further position
ISHLT as the “home” for MCS clinical science and
practice.
• Further, emanating from the strategic planning
process, the ISHLT Board pledged to reject
“international politics” as an agenda for decisionmaking in favor of merit/quality-based decisions
regarding initiatives of global ISHLT interest.
Extending this principle to the MCS registry
initiative, the board invited me to provide a formal
proposal at this Board meeting.
MCS Registry Proposal
• The novel concept I presented in December with
agreement of the Board was the development of an
ISHLT MCS Registry that focuses on collecting
accurate, complete, and verifiable data from any
non-US centers willing to commit to our data
quality process. (This contrasts with the previous
principle of getting any possible data, regardless of
quality). This data would be combined with the
INTERMACS data set to provide “scientific quality”
analyses to seek truths in the global application of
durable MCS , all under the ISHLT brand.
• It is with the spirit of this historical evolution in the
current ISHLT mission that I make the following
proposal.
UMACS
• Established in 2009 at the recommendation of NHLBI,
UMACS is a not-for-profit group based at UAB for the sole
purpose of contracting with national and international
entities for the collection and/or analysis of data about
outcomes in MCS therapy.
• UMACS is NOT supported by the NHLBI and is not a part of
INTERMACS.
• This proposal is from UMACS.
• UNOS would be subcontracted by UMACS (by prior
agreement) only for data collection.
• Center interactions, data management, and analyses would
be performed by UMACS.
IMACS Registry
UAB’s Experience with Registries (Why you should trust us)
Int’l
Years
Inst
Pts
Congenital Heart Surgeons Society Registry (CHSS)
Y
1984-1987
30
2,750
Cardiac Transplant Research Database (CTRD)
N
1990-2010
46
10,000
Pediatric Heart Transplant Study (PHTS)
Y
1993→
44
4,000
ISHLT MCSD Registry (participated in the analysis)
Y
2002-2005
Inter-agency Registry for Mechanically Assisted Circulatory
N
2006→
120
4,500
BeneMACS (Benelux countries with Thoratec)
Y
2009→
5
6
MedaMACS (End stage heart disease: medical treatment)
N
2011→
12
400
655
Assisted Circulatory Devices (INTERMACS)
IMACS Registry
Costs of Registries
Annual
Institutions
Patients
ISHLT Tx
•Registry mechanics
Cost ($)
202,000
46 (35 US)
170
•Analysis
ISHLT MCSD
60
655
INTERMACS
120
1,500
75,000
2.7 million
IMACS Registry
Governance
ISHLT Board of Directors
IMACS Registry Director
UMACS
UNOS
IMACS Registry
Hospital Enrollment
During the last five years we have been contacted by a
number of non-US hospitals desiring to either join
INTERMACS or join an MCSD registry that had similar
definitions and major data elements as INTERMACS.
We have also been contacted by “groups” of hospitals
usually at the national level.
We would create, in collaboration with ISHLT, a proactive
plan for hospital enrollment.
IMACS Registry
Inclusion Criteria
All approved MCSDs (country by country)
Exclusion Criteria
None
IMACS Registry
Adverse Events
Major Events
Device malfunction
Death
Infection episode
Transplant
Bleeding episode
Recovery
Neurological event
Device exchange
IMACS Registry
Data Structure and Elements
•Pre-implant Form
•Implant Form
•Discharge Form
•Follow-up (every 6 months) Form
Adverse Events will be captured in the discharge form
and the follow-up forms.
Note: Exchange of an LVAD or TAH will terminate the first record and will
start a new record.
IMACS Registry
Data Entry: Two Mechanisms
•Direct Entry: The hospital enters data into the ISHLT VAD
Registry.
•Indirect Entry: The hospital enters data into another
database (a national database or consortium database:
known as a collective). The data from the collective is
imported into the ISHLT VAD Registry according to a precise
technical protocol that will be created by UNOS. The
collective would generate the “export file” that meets the
UNOS specifications. This would be similar to the data
transfers for the Tx registry.
IMACS Registry
Deliverables
•A registry
•Quarterly progress reports to ISHLT
•Statistical Reports to ISHLT, hospitals, collectives,
countries
•Data Quality: create and implement a plan
•Disciplined definitions of Outcome Events
•Science/Research
•Web Site (an addendum to the current ISHLT website)
IMACS Registry
Collective Enrollment
During the first year of registry
•Identify and contact any existing MCSD registries (e.g.
JMACS, BeneMACS)
•Create technical document to specify the parameters for
export files (collective to the IMACS Registry)
•Implement the “download”
IMACS Registry
Cost for the Registry*
First Year
Year 2
Year 3
UMACS
$61.500
$50,000
$50,000
UNOS
$133,500
$16,000
$16,000
Total
$196,000
$66,000
$66,000
*excludes collective downloads
IMACS Registry
Cost for the Registry and Statistical Report and Analyses*
First Year
Year 2
Year 3
UMACS
$121.500
$94,000
$94,000
UNOS
$133,500
$16,000
$16,000
Total
$255,000
$110,000
$110,000
*excludes collective downloads
IMACS Registry
Cost for the Registry If Statistical Report and Analyses
Begin in Year 2*
First Year
Year 2
Year 3
UMACS
$61,500
$110,000
$94,000
UNOS
$133,500
$16,000
$16,000
Total
$195,000
$126,000
$110,000
*excludes collective downloads
IMACS Registry
Guiding Principles
•High Quality Database
•Create and implement the registry
•Match implants at a hospital with implants from industry
•Require > 90% compliance with follow-up
•Respond to queries about data inconsistencies or errors
•Conduct training sessions
•Provide Benefits to ISHLT
•Own and direct an international high quality MCSD registry
•Will complement the ISHLT transplant registry as ISHLT
emphasizes it’s role in MCSD research
•Provides Statistical Reports and Research Analyses to
ISHLT Researchers
•Provide Benefits to the hospital
•Statistical summaries of their experience
•Benchmark against the international experience
•Participate in device research
IMACS Registry
RECOMMENDATIONS
• Select proposal with data analyses and hospital reports
beginning in year ($195,000 - 126,000 – 110,000)
• Commit to a 3 year trial period to fully explore this
concept , after which the Board reassesses all aspects
before going further.
• I would act as IMACS registry director for years I through
3 to make sure things are running well and that UMACS is
maximally effective
• An MCS committee would be formed to outline initial
expectations and enrollment goals as well as
opportunities for collective data downloads in MCS.
ISHLT MACS Registry
Registries for Evaluating
Patient Outcomes:
A User’s Guide
Second Edition
347 pages
Publication: September 2010
Agency for Healthcare Research and Quality
Advancing Excellence in Health Care
www.ahrq.gov