the journey for intermacs the journey for mcs the journey for the patient
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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 - PowerPoint PPT PresentationTRANSCRIPT
The Journey for INTERMACSThe Journey for INTERMACSThe Journey For MCSThe Journey For MCS
The Journey for the PatientThe Journey for the Patient
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Directions of ProgressDirections of ProgressStrategies – Profiles - DecisionsStrategies – 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
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Directions of ProgressDirections of ProgressStrategies – Profiles - DecisionsStrategies – 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
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Slow Increase in Profiles Slow Increase in Profiles of Ambulatory Patientsof Ambulatory Patients
0
5
10
15
20
25
30
35
40
45
1 2 3 4 5,6
Year 1Year 2Year 3Year 4Thru 2011
Adapted from Marissa Miller et al, Circ 2009, updated through 2011
% ptsInINTERMACS Inotropes
HomeOral 4
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Su
rviv
al F
ree
of
VA
D o
r T
ran
spla
nt
0
25
50
75
100
0 2 4 6 8
Months since Enrollment
INTERMACS Profiles Risk Stratify AmbulatoryAdvanced Heart Failure Patients
INTERMACS 6/7
INTERMACS 5
INTERMACS 4
P<0.001
Stewart et al. ISHLT 2012INTERMACS A
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Profiles Quantified-2010 1: Crash + Burn 2: Sliding on Ino 3: Stable on Ino 4: Home not dep
N=182 N=212 N=82 N=62
LVDD mm 66 70 71 69
MR mod-sev 42% 62% 50% 47%
TR mod-sev 32% 52% 31% 35%
C.O. L/min 4.7 4.4 4.2 4.5
RAP mm 15 14 9 RAP 13
PAS mm 46 51 53 52
IABP 67% 30%
Ventilator 46% 8%
Creat/BUN 1.6/34 1.6/33 1.4/33 Creatinine 1.6/34
Albumin mg/dl 2.95 3.20 3.60 3.50
Pre-alb mg/dl 12.5 15 21 21
Bilirubin mg/dl 2.2 1.3 1.4 1.1
SGOT 428 72 51 47
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Pre-Albumin in Profiles
0
5
10
15
20
25
1 2 3 4
Liszkowski et al, ISHLT 2010
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Devices Under InvestigationCandidates for Transplant (Bridge)
Differ from Patients For Lifetime Support (Destination)
Trial Population
Bridge to Transplant-
Miller JM 2007
Device as Destination
Slaughter 2009
Age 50 62
% CAD 37% 66%
LVEF 0.16 0.17
Albumin 3.7 3.3
SCreat 1.4 1.6
Hct 35 35IV inotropes 89% 77%
IABP 41% 23%
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Progress of Strategies
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Cumulative ExperienceWith Lifetime Therapy
0102030405060708090100
2008 2009 2010 2011
%DT+Unlikely/Total%DT+Unlikely-Surv
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IS IT TIME BLOW UP THE BRIDGE?
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Strategies And Outcomes
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Mature Citizens On The Putting Green At St. Andrews:
Which Ones Are VAD Candidates?
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Multiple Dimensions of Decisions Multiple Dimensions of Decisions Beyond SurvivalBeyond Survival
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What Does the Patient What Does the Patient with Advanced Heart Failure Want?with Advanced Heart Failure Want?
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EQ-5D EQ-5D Grady et al, ISHLT Prague 2012Grady et al, ISHLT Prague 2012
0.0%10.0%20.0%30.0%40.0%50.0%60.0%70.0%80.0%90.0%
100.0%
Level 1: Level 2: Level 3: Level 4: Levels 5-7
Pre-Implant
3 months post implant
1 year post implant
Grady et al,ISHLT 2012
0.0%10.0%20.0%30.0%40.0%50.0%60.0%70.0%80.0%90.0%
100.0%
Level 1: Level 2: Level 3: Level 4: Levels 5-7
Pre-Implant
3 months post implant
1 year post implant
Self Care – Any Problems Mobility – Any Problems
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Euroqol VAS Score by HF SeverityEuroqol VAS Score by HF Severity
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.IN
TERMACS Annual M
eeting
March 2012
Even The Most Fantastic Electronic Data EntryEven The Most Fantastic Electronic Data Entry
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2020
Profile 1
Profile 4Oral Rx home
Profile 5
Profile 6
Profile 2
Profile 3Stable on Ino
Profile 7
DeviceOr Death
DifferentDecisions
Early DaysOf Implantable DevicesAnd INTERMACS
Re-launch into a new era
Growing Need to Refine Profilesof disease severity
Urgent need to find out function and quality outcomesto support shared decision-making
Who Are Your Patients?
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Directions of ProgressDirections of ProgressStrategies – Profiles - DecisionsStrategies – 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
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Overview of INTERMACS
•Business Plan Update Collum
Sixth Annual Meeting, March 12, 2012
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6th Annual Meeting – March 12, 2012
Business Plan Update
Craig Collum, MPH
Executive Director
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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.
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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
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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)
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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
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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 $213,141IT 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
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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
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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
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6th Annual Meeting – March 12, 2012
INTERMACS A
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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
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6th Annual Meeting – March 12, 2012
INTERMACS A
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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
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6th Annual Meeting – March 12, 2012
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6th Annual Meeting – March 12, 2012
How close are we to our Goal?
Budget $13,769,886
Money Received $ 6,624,999
Additional Funds 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
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Awards and Recognition of New Members
James Young, MD
Sixth Annual Meeting, March 12, 2012
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INTERMACS Vanguard Centers
• Regulatory Compliance = 100%• Participated in INTERMACS = 1Year• Minimum Enrollment = 20 Patients• Data Compliance = 95%• Currently Activated
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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
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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
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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
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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
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