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The Journey for INTERMACS The Journey For MCS The Journey for the Patient

The Journey for INTERMACS The Journey For MCS The Journey for the Patient. INTERMACS Annual Meeting March 2012. Directions of Progress Strategies – Profiles - Decisions. Dynamic states Dramatic improvement in MCS progress Evolving strategy and intent of MCS at implant

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The Journey for INTERMACS The Journey For MCS The Journey for the Patient

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  1. The Journey for INTERMACSThe Journey For MCSThe Journey for the Patient INTERMACS Annual Meeting March 2012

  2. Directions of ProgressStrategies – Profiles - Decisions • Dynamic states • Dramatic improvement in MCS progress • Evolving strategy and intent of MCS at implant • Profiles of patients – for risk, for benefit, for decisions • Decision-making • New dimensions beyond survival • Function/QOL outcomes now highly relevant • Individual patient-centered INTERMACS Annual Meeting March 2012

  3. Directions of ProgressStrategies – Profiles - Decisions • Dynamic states • Dramatic improvement in MCS progress • Less recent change in optimal “medical” therapy • No change in cardiac transplantation except candidate status • Evolving strategy and intent of MCS at implant • Profiles of patients – for risk, for benefit, for decisions • Decision-making • New dimensions beyond survival • Function/QOL outcomes now highly relevant • Individual patient-centered INTERMACS Annual Meeting March 2012

  4. Slow Increase in Profiles of Ambulatory Patients % pts In INTERMACS Inotropes Home Oral 4 INTERMACS Annual Meeting March 2012 Adapted from Marissa Miller et al, Circ 2009, updated through 2011

  5. INTERMACS Annual Meeting March 2012

  6. INTERMACS Profiles Risk Stratify Ambulatory Advanced Heart Failure Patients 100 75 P<0.001 Survival Free of VAD or Transplant 50 INTERMACS 6/7 INTERMACS 5 INTERMACS 4 25 INTERMACS Annual Meeting March 2012 0 0 2 4 6 8 Months since Enrollment Stewart et al. ISHLT 2012

  7. Profiles Quantified-2010 INTERMACS Annual Meeting March 2012

  8. Pre-Albumin in Profiles INTERMACS Annual Meeting March 2012 Liszkowski et al, ISHLT 2010

  9. Devices Under InvestigationCandidates for Transplant (Bridge)Differ from Patients For Lifetime Support (Destination) INTERMACS Annual Meeting March 2012

  10. Progress of Strategies INTERMACS Annual Meeting March 2012

  11. Cumulative ExperienceWith Lifetime Therapy INTERMACS Annual Meeting March 2012

  12. IS IT TIME BLOW UP THE BRIDGE? INTERMACS Annual Meeting March 2012

  13. Strategies And Outcomes INTERMACS Annual Meeting March 2012

  14. Mature Citizens On The Putting Green At St. Andrews:Which Ones Are VAD Candidates? INTERMACS Annual Meeting March 2012

  15. Multiple Dimensions of Decisions Beyond Survival INTERMACS Annual Meeting March 2012

  16. What Does the Patient with Advanced Heart Failure Want? INTERMACS Annual Meeting March 2012

  17. EQ-5D Grady et al, ISHLT Prague 2012 Self Care – Any Problems Mobility – Any Problems Grady et al, ISHLT 2012 INTERMACS Annual Meeting March 2012

  18. Euroqol VAS Score by HF Severity INTERMACS Annual Meeting March 2012 INTERMACS; Grady K, et al J Heart Lung Trans 2009;28:S269. MEDAMACS: Patel P, et al. ISHLT 2012. HF Action; Flynn K, et al. Am Heart J 2009;158:564-71.

  19. Even The Most Fantastic Electronic Data Entry INTERMACS Annual Meeting March 2012

  20. Who Are Your Patients? Device Or Death Profile 1 Early Days Of Implantable Devices And INTERMACS Profile 2 Different Decisions Re-launch into a new era Growing Need to Refine Profiles of disease severity Urgent need to find out function and quality outcomes to support shared decision-making Profile 3 Stable on Ino Profile 4 Oral Rx home Profile 5 Profile 6 INTERMACS Annual Meeting March 2012 Profile 7

  21. INTERMACS Annual Meeting March 2012

  22. Directions of ProgressStrategies – Profiles - Decisions • Dynamic states • Dramatic improvement in MCS progress • Less recent change in optimal “medical” therapy • No change in cardiac transplantation except candidate status • Evolving strategy and intent of MCS at implant • Profiles of patients – for risk, for benefit, for decisions • Decision-making • New dimensions beyond survival • Function/QOL outcomes now highly relevant • Individual patient-centered INTERMACS Annual Meeting March 2012

  23. Sixth Annual Meeting, March 12, 2012 • Overview of INTERMACS • Business Plan Update Collum INTERMACS Annual Meeting March 2012

  24. 6th Annual Meeting – March 12, 2012 • Business Plan Update • Craig Collum, MPH • Executive Director INTERMACS Annual Meeting March 2012

  25. 6th Annual Meeting – March 12, 2012 • Contract requires the development of a cost sharing plan • The Cost Sharing plan is a collaboration plan not limited to a Public/Private partnership that integrates industry and other non-NHLBI collaboration (hospitals) and financial support for the INTERMACS enterprise on an increasing scale so that at the end of the five years the NHLBI financial contribution to maintain the registry would be significantly reduced. INTERMACS Annual Meeting March 2012

  26. 6th Annual Meeting – March 12, 2012 • Plan should provide for the following: • Financial support for maintenance of data quality and completeness and data access, and the rigor and objectivity of the database and registry policies and procedures • An external advisory board to advise on integration of industry and hospital involvement in the Registry and long-term sustainability plans. • Business Advisory Committee INTERMACS Annual Meeting March 2012

  27. 6th Annual Meeting – March 12, 2012 • Who makes up the Business Advisory Committee? • Representatives from INTERMACS • PI, DCC Director, Executive Director & Chair • Representatives from NHLBI • Project Officer • Representatives from Industry • Thoratec, Syncardia and Heartware • Representatives from Hospitals • Hospital Representatives (TBD) • Regional (West, Central and East) INTERMACS Annual Meeting March 2012

  28. 6th Annual Meeting – March 12, 2012 • What is the charge of the Business Advisory Committee? • The committee is charged with advising INTERMACS on the integration of industry and hospital involvement in the Registry and long-term sustainability plans INTERMACS Annual Meeting March 2012

  29. 6th Annual Meeting – March 12, 2012 • INTERMACS Budget (2010-2015) • Labor (Salary + Fringe) $8,832,339 • Supplies $91,080 • Travel $313,476 • Other Direct Costs $213,141 • IT Support, Server Costs, Teleconferences, etc. • Subcontracts $2,357,621 • MedaMACS Site Payments* $395,500 • Indirect Costs $1,566,730 • Total$13,769,886 • * Sponsored by Thoratec INTERMACS Annual Meeting March 2012

  30. 6th Annual Meeting – March 12, 2012 • How do we pay for INTERMACS? • NHLBI Component • Contract with UAB to serve as Data Coordinating Center • $5,299,999 • Hospital Component • Hospital participation fees • $10,000 annually • Meets CMS/Joint Commission Requirement for Destination Therapy Certification • Provides quarterly QA reports to hospitals • Provides benchmarking to hospitals • Provides clinical summaries of patients INTERMACS Annual Meeting March 2012

  31. 6th Annual Meeting – March 12, 2012 • How do we pay for INTERMACS? • Industry Component • Approved Devices • $100 per device record • Allows a company access to device records on approved devices entered into the registry manufactured by the requesting company • Pre-Market Approval Studies • $3000 Per Device Record • Allows a company access to device records on devices not manufactured by requesting company for use as control data for a pre-market approval study requirement INTERMACS Annual Meeting March 2012

  32. 6th Annual Meeting – March 12, 2012 • How do we pay for INTERMACS? • Industry Component • Post-Market Approval Studies • $500 Per Device Record • Allows a company access to device records on devices manufactured by the requesting company if the data is needed to meet a condition of approval (CoA) post market study requirement • Allows a company access to device records on devices not manufactured by the requesting company for use as control data for a CoA post market study requirement • MedaMACS Support • Contract between Thoratec and UAB • Allows up to $395,500 for site reimbursement INTERMACS Annual Meeting March 2012

  33. 6th Annual Meeting – March 12, 2012 • Business Plan Update • Anticipated Funding • NIH Contract $5,299,999 • Hospital Fees $6,150,000 • Industry Fees $2,320,000 • Grand Total $13,769,999 INTERMACS Annual Meeting March 2012

  34. 6th Annual Meeting – March 12, 2012 INTERMACS Annual Meeting March 2012

  35. 6th Annual Meeting – March 12, 2012 • Business Plan Update • Actual Funding (As of 11/30/2011) • NIH Contract $5,299,999 • Hospital Fees $1,200,000 • Industry Fees $125,000 Grand Total $6,624,999 INTERMACS Annual Meeting March 2012

  36. 6th Annual Meeting – March 12, 2012 INTERMACS Annual Meeting March 2012

  37. 6th Annual Meeting – March 12, 2012 • How close are we to our Goal? • Budget $13,769,886 • Money Received $ 6,624,999 • AdditionalFunds Needed $ 7,144,887 • How are we going to fund the remaining $7,144,887? • NIH Contract $0 • Hospital Fees $4,950,000 • Industry Fees $2,195,000 INTERMACS Annual Meeting March 2012

  38. Sixth Annual Meeting, March 12, 2012 Awards and Recognition of New Members James Young, MD INTERMACS Annual Meeting March 2012

  39. INTERMACS Vanguard Centers Regulatory Compliance = 100% Participated in INTERMACS = 1Year Minimum Enrollment = 20 Patients Data Compliance = 95% Currently Activated INTERMACS Annual Meeting March 2012

  40. Vanguard Centers • Integris Baptist Med. Center, Oklahoma City, OK • Baptist Memorial Hospital, Memphis, TN • Ochsner Medical Center, New Orleans, LA • Johns Hopkins Hospital, Baltimore, MD • Robert Wood Johnson Univ., New Brunswick, NJ • Yale-New Haven Hospital, New Haven, CT • Sentara Norfolk General Hosp., Norfolk, VA • Henry Ford Hospital, Detroit, MI • Univ. of Iowa Hosp. & Clinics, Iowa City, IA INTERMACS Annual Meeting March 2012

  41. Vanguard Centers • Strong Mem/Univ of Rochester, Rochester, NY • Univ. of Colorado Hosp., Aurora, CO • Univ. of Washington Med. Center, Seattle, WA • Mayo Clinic, Jacksonville, FL • St. Luke’s Med. Center/Aurora, Milwaukee, WI • Northwestern University, Chicago, IL • Univ. of Michigan, Ann Arbor, MI • Seton Medical Center, Austin, TX • Temple University Hospital, Philadelphia, PA INTERMACS Annual Meeting March 2012

  42. Vanguard Centers • Univ. Virginia Health, Charlottesville, VA • Tufts Medical Center, Boston, MA • Baptist Health Medical, Little Rock, AR • Mayo Clinic, Phoenix, AZ • Univ. of Pittsburgh, Pittsburgh, PA • Cedars-Sinai Med. Center, Los Angeles, CA • Columbia-Presbyterian, New York, NY • Massachusetts General, Boston, MA • Cleveland Clinic, Cleveland, OH INTERMACS Annual Meeting March 2012

  43. Vanguard Centers • Providence Sacred Heart, Spokane, WA • Emory University Hosp., Atlanta, GA • UT Southwestern, Dallas, TX • Univ. of Alabama at B’ham, B’ham, AL • Mayo Clinic, Rochester, MN INTERMACS Annual Meeting March 2012

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