A Proposal for the IMACS

(ISHLT Mechanically Assisted Circulatory Support)

Registry

James K. KirklinApril 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.

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

UAB’s Experience with Registries (Why you should trust us)

IMACS Registry

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

Costs of Registries

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

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

Cost for the Registry*

IMACS Registry

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

Cost for the Registry and Statistical Report and Analyses*

IMACS Registry

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

Cost for the Registry If Statistical Report and Analyses Begin in Year 2*

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.

IMACS Registry

Registries for Evaluating Patient Outcomes:A User’s GuideSecond Edition

347 pagesPublication: September 2010

Agency for Healthcare Research and QualityAdvancing Excellence in Health Care www.ahrq.gov

ISHLT MACS Registry