Sixth Annual Meeting March 12, 2012 8:00am to 4:00pm Crowne Plaza National Airport Arlington, VA

Sixth Annual MeetingMarch 12, 2012

8:00am to 4:00pm

Crowne Plaza National AirportArlington, VA

INTERMACS Annual Meetin

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Welcome

James Young, MDINTERMACS Study Chair

Sixth Annual Meeting, March 12, 2012


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We would like to welcome our new INTERMACS hospitals in Canada


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Conflict of InterestPresenters and panel members are members of Hospitals, National Heart, Lung and Blood Institute, Food and Drug Administration, United Network for Organ Sharing, and Device Manufacturers.

Financial Disclosures from presenters and panel members include equity interests in the form of stocks and employment, and significant payments to individuals and institutions for consulting and clinical trials.

Please contact INTERMACS for a full list of disclosures.



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Folder Contents• Agenda• Slide Handouts ?• ISHLT 2012 Abstracts and itinerary• Publication, J. Kirklin• List of all INTERMACS Publications, Abstracts and Authors• Evaluation



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What is INTERMACS ?INTERMACS is the United States national registry for patients who are receiving durable, FDA approved mechanical circulatory support device therapy to treat advanced heart failure. This registry was devised as a joint effort of the National Heart, Lung and Blood Institute (NHLBI), the Centers for Medicare and Medicaid Services (CMS), the Food and Drug Administration (FDA), clinicians, scientists and industry representatives.



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• Facilitate the refinement of patient selection to maximize outcomes with current and new device options.

• Identify predictors of good outcomes as well as risk factors for adverse events after device implantation.

• Develop consensus “best practice” guidelines to improve clinical management by reducing short and long term complications of MCSD therapy.

• Guide clinical application and evolution of next generation devices.

• Utilize Registry information to guide improvements in technology, particularly as next generation devices evolve.

Goals of the Registry


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INTERMACS Annual Meetings

020406080

100120140160180200

2007(ISHLT)

2008(ISHLT)

2009(ACC)

2010(ISHLT)

2011(ISHLT)

133

178

150

176Registered170



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Original ContractMay 31, 2005 – May 30, 2010

Contract ExtensionMay 31, 2010 – November 30, 2010

Second ContractDecember 1, 2010 – November 30, 2015



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Impact of INTERMACS

•> 700 publications refer to INTERMACS



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“Perhaps the most successful example of a coordinated effort to study newly introduced devices has been the Interagency Registry

for Mechanically Assisted Circulatory Support (INTERMACS), established to capture

detailed clinical data on all patients receiving implantable ventricular assist pumps in

the United States.”Postmarketing Surveillance of Medical Devices - Filling in the Gaps

Frederic S. Resnic, M.D., and Sharon-Lise T. Normand, Ph.D.February 14th, 2012


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INTERMACS 2012: Past, Present and Future



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Overview of INTERMACS

•INTERMACS Re-LaunchINTERMACS PediMACS

•INTERMACS Website: A New Look•Business Plan Update



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• What is on the horizon?– Revisit Adverse Event Definitions– New Data Elements – Revamped Auditing – Quality Assurance Reports including benchmarking– Expand and Augment

• Collection of Functional Capacity, Quality of Life and Neurocognitive Assessments

– Revisit Process for Submitting Research Requests– Standardized Data Sets

INTERMACS RENEWAL: April 2011


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DONE

INTERMACS RENEWAL: April 2011

• What is on the horizon?– Revisit Adverse Event Definitions– New Data Elements – Revamped Auditing – Quality Assurance Reports including benchmarking– Expand and Augment

• Collection of Functional Capacity, Quality of Life and Neurocognitive Assessments

– Revisit Process for Submitting Research Requests– Standardized Data Sets


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Overview of INTERMACS

•INTERMACS Re-Launch NaftelINTERMACSPediMACS



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Coordinator Training Session: March 11, 2012

Status of INTERMACS Re-Launch

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INTERMACS Naftel

pediMACS Naftel


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INTERMACS Re-launch Status

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Our Goals: Reduce the number of elements and forms Streamline the data entry process Clarify elements that were confusing in the past Examine the AE definitions for current clinical

relevance


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We (INTERMACS PIs, NIH, various committees, Site Coordinators, Site Administrators, etc.) have spent 1 year reviewing the WBDE in all aspects: AE definitions and other definitions Screens / Forms Data Elements Patient Flow through the WBDE


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Live test site Currently available (March 9, 2011) Testing by INTERMACS Nurse Monitors Testing by the DCC Data Managers Testing by the INTERMACS Co-PIs Testing by 3 Hospitals (Beta Sites) Testing NOW during this live training session

Target Launch Date: April 4, 2012 Training will be available before launch date

Live Test SiteMarch 9, 2012

LAUNCHApril 4, 2012

Mar 11 - Mar 30

“March Madness”


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pediMACSWill be discussed later today

David C. Naftel, PhD

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INTERMACS Website: A New Look

Mary Lynne Clark


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Investigators


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Enrolled Sites


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Documents

Sixth Annual Meeting March 12, 2012 8:00am to 4:00pm Crowne Plaza National Airport Arlington, VA