PPT - International Society for Heart and Lung Transplantation

Document Sample
PPT - International Society for Heart and Lung Transplantation Powered By Docstoc
					              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 decision-
  making 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               655
Inter-agency Registry for Mechanically Assisted Circulatory   N       2006→        120       4,500
          Assisted Circulatory Devices (INTERMACS)
BeneMACS (Benelux countries with Thoratec)                    Y       2009→              5         6
MedaMACS (End stage heart disease: medical treatment)         N       2011→         12         400
                          IMACS Registry

 Costs of Registries

                                                    Annual
                          Institutions   Patients            Cost ($)
ISHLT Tx                                                     202,000
    •Registry mechanics   46 (35 US)     170
    •Analysis
ISHLT MCSD                 60             655                75,000
INTERMACS                 120            1,500               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

				
DOCUMENT INFO
Shared By:
Categories:
Tags:
Stats:
views:76
posted:2/15/2012
language:English
pages:22