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

Sixth Annual MeetingMarch 12, 20128:00am to 4:00pm

Crowne Plaza National AirportArlington, VA

INTERMACS Annual MeetingMarch 2012

Welcome

James Young, MDINTERMACS Study Chair

Sixth Annual Meeting, March 12, 2012INTERMACS Annual MeetingMarch 2012

We would like to welcome our new INTERMACS hospitals in CanadaINTERMACS Annual MeetingMarch 2012

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.Sixth Annual Meeting, March 12, 2012INTERMACS Annual MeetingMarch 2012

Folder Contents Agenda Slide Handouts ? ISHLT 2012 Abstracts and itinerary Publication, J. Kirklin List of all INTERMACS Publications, Abstracts and Authors EvaluationSixth Annual Meeting, March 12, 2012INTERMACS Annual MeetingMarch 2012

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. Sixth Annual Meeting, March 12, 2012INTERMACS Annual MeetingMarch 2012

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 RegistryINTERMACS Annual MeetingMarch 2012

INTERMACS Annual Meetings133178150176Registered170Sixth Annual Meeting, March 12, 2012INTERMACS Annual MeetingMarch 2012

Original ContractMay 31, 2005 May 30, 2010

Contract ExtensionMay 31, 2010 November 30, 2010

Second ContractDecember 1, 2010 November 30, 2015 Sixth Annual Meeting, March 12, 2012INTERMACS Annual MeetingMarch 2012

Impact of INTERMACS

> 700 publications refer to INTERMACSSixth Annual Meeting, March 12, 2012INTERMACS Annual MeetingMarch 2012

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 GapsFrederic S. Resnic, M.D., and Sharon-Lise T. Normand, Ph.D.February 14th, 2012INTERMACS Annual MeetingMarch 2012

INTERMACS 2012: Past, Present and FutureSixth Annual Meeting, March 12, 2012INTERMACS Annual MeetingMarch 2012

Overview of INTERMACS

INTERMACS Re-LaunchINTERMACS PediMACSINTERMACS Website: A New LookBusiness Plan Update


What is on the horizon?Revisit Adverse Event DefinitionsNew Data Elements Revamped Auditing Quality Assurance Reports including benchmarkingExpand and AugmentCollection of Functional Capacity, Quality of Life and Neurocognitive AssessmentsRevisit Process for Submitting Research RequestsStandardized Data Sets

INTERMACS RENEWAL: April 2011INTERMACS Annual MeetingMarch 2012

DONEINTERMACS RENEWAL: April 2011What is on the horizon?Revisit Adverse Event DefinitionsNew Data Elements Revamped Auditing Quality Assurance Reports including benchmarkingExpand and AugmentCollection of Functional Capacity, Quality of Life and Neurocognitive AssessmentsRevisit Process for Submitting Research RequestsStandardized Data Sets


Overview of INTERMACS

INTERMACS Re-LaunchNaftelINTERMACSPediMACS


Coordinator Training Session: March 11, 2012 Status of INTERMACS Re-Launch*INTERMACSNaftel

pediMACSNaftelINTERMACS Annual MeetingMarch 2012

Coordinator Training Session: March 11, 2012

INTERMACS Re-launch Status

*Our Goals:Reduce the number of elements and forms Streamline the data entry processClarify elements that were confusing in the pastExamine the AE definitions for current clinical relevance




*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 definitionsScreens / FormsData Elements Patient Flow through the WBDE




*

Live test siteCurrently available (March 9, 2011)Testing by INTERMACS Nurse MonitorsTesting by the DCC Data ManagersTesting by the INTERMACS Co-PIsTesting by 3 Hospitals (Beta Sites)Testing NOW during this live training sessionTarget Launch Date: April 4, 2012Training will be available before launch date

Live Test SiteMarch 9, 2012LAUNCHApril 4, 2012Mar 11 - Mar 30March MadnessINTERMACS Annual MeetingMarch 2012

Coordinator Training Session: March 11, 2012 pediMACS

Will be discussed later today

David C. Naftel, PhD*INTERMACS Annual MeetingMarch 2012

INTERMACS Website: A New Look

Mary Lynne ClarkINTERMACS Annual MeetingMarch 2012

Sixth Annual Meeting, March 12, 2012



InvestigatorsINTERMACS Annual MeetingMarch 2012


Enrolled SitesINTERMACS Annual MeetingMarch 2012



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Documents

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