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Seventh Annual Meeting New Data, New Thoughts, New Directions April 5-6, 2013 5:30pm to 9:00pm Crowne Plaza National Airport Arlington, VA 1 INTERMACS Annual Meeting, April 2013
Seventh Annual MeetingNew Data, New Thoughts, New Directions
April 5-6, 2013
5:30pm to 9:00pm
Crowne Plaza National AirportArlington, VA
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Financial Disclosure
INTERMACS Speaker Company Affiliation RelationshipFrancis Pagani, MD HeartWare Research Support
David Naftel, PhD HeartWare, Thoratec Consultant
Don Middlebrook Thoratec Employee
David Hathaway, MD HeartWare Employee
Disclosure: Current guidelines state that INTERMACS member make aware any affiliation or financial interest that may affect that associate’s participation. Each member has been requested to complete a disclosure statement. The names of the members that have indicted a relationship which could be perceived as a potential conflict of interest (e.g. ownership of stock, significant honoraria/consulting fees, or direct research support from a commercial organization) are listed below.
Additionally, all presentation speakers have been asked to disclose any financial interest or affiliations and to indicate if a product they are discussing is not labeled for the used under discussion or is still investigational.
INTERMACS Seventh Annual Meeting April 2013
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INTERMACS Annual
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Session 1Friday, April 5
5:30pm – 9:00pm
3
5:30 Registration/Dinner
6:00 Welcome6:10 INTERMACS: Accomplishments & Challenges7:00 INTERMACS Data Collection: Expansions & Clarifications7:30 Break7:45 Waiver of Consent: Is it Possible?8:00 The Latest Hospital Quarterly QA Report: An Evaluation Tool for Local Programs8:45 INTERMACS Awards
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Welcome James Young
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INTERMACS: Accomplishments &
ChallengesJames Kirklin
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Original ContractMay 31, 2005 – May 30, 2010
Contract ExtensionMay 31, 2010 – November 30, 2010
Latest ContractDecember 1, 2010 – November 30, 2015
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Original Contract and Deliverables
May 31, 2005 – May 30, 2010(Highlights)
Article C.1. Statement of Work
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The Contractor shall Collect information pertaining to patients, care providers, hospitals,
devices and provide customized data sets.
Develop protocols to collect data to answer research questions.
Establish a Steering Committee to include at least 1 representative from CMS, FDA, a study chair, DCC PI, members from representative participating hospitals and the NHLBI Project Officer. Develop drafts and the final protocol, establish standard procedures and forms and provide and distribute the forms. Submit the protocol and any
amendments thereto, to the DSMB for review and the NHLBI for approval.
Original Contract: May 2005 – May 2010
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Work with the SC to develop criteria for certification and approval of each participating hospital as a member of the Registry. Develop methods to expeditiously implement certification and to monitor hospital performance. Work with the SC to establish policies and procedures to ensure satisfactory performance by participating
hospitals. Train staff of participating hospitals in Registry methods of data, blood and tissue collection such that eligible hospitals can be certified to participate in the Registry. Eliminate hospitals failing to meet or maintain performance standards and identify and certify replacement hospitals.
Work with the SC to develop a manual of operations based on the Registry protocol for the participating hospitals and obtain NHLBI approval of the MOO. The MOO shall include plans for collecting patient data in compliance with patient privacy regulations and for proper cross referencing to the source documents. (Protect proprietary information while analysis of safety and outcomes is enabled); Include policies and procedures including standard definitions of adverse events and other key definitions of endpoint of interest. Include
operating policies such as publications, conflict of interest and data sharing.
Original Contract: May 2005 – May 2010
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Work with the SC to develop an informed consent document (with required elements) for use by each participating hospital.
Ensure that consents contain NIH elements and IRB approvals are current.
Serve as the repository for the clinical data collected
This will require the following:
Develop procedures to inform appropriate personnel at each participating hospital of the requirements for data
collection; Monitor hospitals to ensure the data are forwarded to the DCC in a timely manner; Review all clinical data transmitted by the participating hospitals to ensure completeness and quality control prior to processing; Develop a procedure for analysis of a large number of
clinical measures needed to characterize patients enrolled and their outcomes including functional status, adverse events, subsequent
hospitalizations, quality of lie and survival; Maintain liaison with each participating hospital to assist in the resolution of operational problems involved in collecting and reporting data; Develop computer software necessary to process and store all clinical data electronically;
Original Contract: May 2005 – May 2010
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Provide statistical analysis of the data and develop the necessary software for this analysis.
Prepare and distribute monthly reports to include patient recruitment in various categories and the hospitals providing the data, status of follow-up data
collection, data analysis, problems encountered, if any, with the quality of data received.
Develop standard reports for CMS.
Develop standard reports for FDA in accordance with FDA requirements.
Every 3 months provide to the NHLBI a summary of data collected and received during that period on patients receiving MCSDs. - Part of Quarterly reports.
Prepare and distribute to the participating hospitals brief semi-annual summaries of the progress of the Registry.
Arrange meetings of the DSMB to be held at least twice a year, provide summaries of the data analysis and specific patient data sets as requested
by NHLBI and DSMB Members. Prepare and distribute minutes of the meetings.
Coordinate with the NHLBI and manage meetings and conference calls of the SC; prepare and distribute minutes of the meetings.
Original Contract: May 2005 – May 2010
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Plan and conduct an annual conference for Registry and other interested investigators to present and review MCSD Registry data.
Prepare interim limited access data sets, consistent with NHLBI policies. Provide interim data sets to NHLBI approved investigators.
Provide a final consolidate copy of patient data in hard copy and computerized tape formats, along with the supporting documents.
Transcribe into Registry forms and enter into the Registry data base, information on patients that received MCSDs as destination therapy for heart failure prior to the initiation of the MCSD Registry.
Perform site visits with record audits to determine the accuracy of web-based data submitted and information contained in source documents.
Work with participating hospitals to prepare for publication abstracts and manuscripts resulting from the Registry.
Original Contract: May 2005 – May 2010
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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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Contract Extension Deliverables
May 31, 2010 – November 31, 2010
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Latest Contract and Deliverables
December 1, 2010 – November 31, 2015(Highlights)
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1. Implementation of a collaboration plan that integrates Industry and other non-NHLBI groups for financial support
• Data quality and completeness, data access, objectives, policies and procedures • External advisory board
2. Maintaining Registry/Data Coordinating Center• Continue data collection on current and new patients• Maintain above• Develop and maintain a computer system• Website (distribution of info) • Section 508 compliance • Develop software for future government use – • Submit information system security plan – • Revise protocol and informed consent to reflect INTERMACS as the recipient,
verify required elements, re-consent all current patients • Maintain procedures to inform sites of requirements for data collection per protocol
and Manual of Operations • Monitor hospitals to ensure data are forwarded to DCC in a timely manner- • Maintain data quality and reporting compliance by reviewing all clinical data
transmitted by sites to ensure completeness and quality control.• Maintain liaison with sites to assist in resolution of problems collecting and
reporting data.
Latest Contract: Dec 2010 - Nov 2015
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3. Maintain and support existing OC and SC structure and function including NIH, CMS, FDA, PIs, Sites, Sub-committees. Schedule meetings, conference lines, meeting facilities, materials, bulletin area on password protected website, meeting minutes and reports.
4. Arrange conference calls for OSMB, provide summaries, prepare and distribute minutes
5. Maintain certification of new and existing sites, monitor hospital performance, develop and train new sites/staff and provide review program, institute remedial actions for hospitals failing to meet or maintain performance standards or eliminate sites unable to maintain standards in collaboration with the Hosp. Training and Standards Committee
6. Maintain and support regulatory requirements for patient privacy and good clinical practices, new site IRB submission and regulatory documents for existing sites. Assure consents have NIH required elements
7. Expand and augment collection of functional capacity, health status (qual. of life) and neurocognitive assessments
8. Provide statistical analyses to Federal partners and DAAP approved investigators9. Prepare and distribute quarterly reports for sites including patient recruitment, status
of follow-up, data compliance, etc.10. Quarterly individualized industry data reports
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11. Semi-annual progress reports of the registry12. Plan and conduct annual conference13. Prepare interim limited data sets consistent with NHLBI policies14. Six months before end of contract, provide a final copy of de-identified data in
hard copy and computerized disc formats along with support documents15. Conduct site visits to 100% of sites. Perform record audits to determine accuracy of WBDE and conduct for-cause visits/audits as needed16. Work with sites and investigators to prepare abstracts and manuscripts17. Extend research collaborations beyond the current INTERMACS investigators18. Develop and execute procedures to made data collection software and associated documentation transportable for future government or non- government use. 19. Conduct Pilot registry (MedaMACS)
Latest Contract: Dec 2010 - Nov 2015
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COST SHARING REPORT
NIH $8,995,130.00
• Original $5,299,999.00• Supplement $3,695,131.00
Cost Share $3,401,520.00
• Hospital Dues $3,107,520.00• Industry $ 294,000.00
Total $12,396,650.00
Funding SupportDecember 1, 2010 – March 29, 2013
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NIH 72%
Industry2%
Hospitals25%
Actual Funding Support
COST SHARING REPORTDecember 1, 2010 – March 29, 2013
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1. May 31, 2007 Minor revisions to web-based data entry (Protocol v2.2)
2. March 5, 2009 Significant form revision (e.g. bleeding form)(Protocol v2.3)
3. May 2, 2012 INTERMACS Re-Launch (Protocol v3.0)
INTERMACS Form Revisions
Workshop for the Executive Committee, FDA, and Industry
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1.Quality Assurance Reports 2.Medical Device Reports3.Medical Event Review
Additional Initiatives
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Seventh Annual Meeting, April 5-6, 2013
Publication Record
Number of co-authors: 154
Number of abstracts: 48
Number of published papers: 18
Number of citations: 824
Google Scholar search resultsfor the term INTERMACS: 1,330INTERMACS Annual
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10
8
14
6
0
23 3
2
6
2
0
2
4
6
8
10
12
14
16
18
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2007 2008 2009 2010 2011 2012 2013
Abstracts Papers
# of
abs
trac
ts/p
ublic
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24
Publications June 2006 - March 2013
Year
48 18
(Thru March)
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Fifth Annual Meeting, April 12, 2011
INTERMACS for Pre and Post Market Studies
From the beginning of INTERMACS, FDA has been an active partner and has been “at the table” during all discussions of adverse event definitions, quality of life assessment, neurological assessment, functional capacity measurements, follow-up schedule, audit process, medical event review, etc.
FDA has encouraged device manufacturers to review all aspects of INTERMACS as they plan their pre-market and post market studies.
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Benefits of using INTERMACS for post market studies– FDA receptive to using INTERMACS registry in order to meet PMA conditions of
approval post market studies– INTERMACS study protocol already approved by the Institutions IRB– Institution personnel involved in MCS therapy already trained and familiar with
INTERMACS data entry requirements– Reduces the burden for study sites because they don’t have multiple study CRFs
to complete to meet the PAS requirements– INTERMACS registry data can serve as a contemporaneous control group to
evaluate new MCS performance in a commercial setting– Enrollment can begin immediately after MCS device manufacturer receives FDA
approval for their PAS protocol– INTERMACS provides periodic data summaries to allow MCS manufacturer to
quickly summarize and prepare PMA post approval periodic reports– INTERMACS can assist enrolling centers in meeting MDR User Facility reporting
requirements– INTERMACS PAS data can be used to update labeling with real world
experience– Use of INTERMACS registry is the least burdensome and most cost effective
means to gather required PAS data to meet PMA condition of approval study requirements
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Pre- and Post Market Studies Using INTERMACS Summary
Post Market StudiesThoratec, HMII BTT Post Market Study complete Nov 2011
Results confirm pivotal trial
Thoratec, HMII DT Post Market Study will be complete 2013
Pre-Market StudiesBerlin Heart, EXCOR Pre-Market FDA Approval 12/16/2011 (INTERMACS provided statistical support)Heartware, HVAD Pre-Market FDA Approval 11/20/2012
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Workshop for the Executive Committee, FDA, and Industry
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The ‘MACS’ Family• INTERMACS
o INTERMACS: Adultso pediMACS: Pediatrico CanaMACS: Adults + Pediatric
• IMACS (ISHLT Initiative)• MEDAMACS (Medically treated patients)• JMACS• BENEMACS
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Seventh Annual Meeting, April 5-6, 2013
INTERMACS
MedaMACS
PediMACS U-MACS
IMACS
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Seventh Annual Meeting, April 5-6, 2013
Partnerships
• Federal Partners – FDA, CMS, NHLBI
• Industry
• Member Institutions/CentersINTERMACS Annual
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Panel Discussion: NIHMarissa Miller
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A Dialogue on Current Budget Challenges and Their Impact on
INTERMACS
Marissa A. Miller, DVM, MPHChief, Advanced Technologies and Surgery Branch
National Heart, Lung, and Blood Institute
Financial disclosures: None
INTERMACS Annual MeetingApril 5, 2013
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Budget Control Act of 2011
***Gross Public Debt stood at $14.3 trillion ***Immediate $400 billion increase in debt ceiling, additional
increases of $1.7 trillion ***Initial $900 billion cut in spending over ten years, largely
from discretionary spending. Capped discretionary spending going forward
***Established the Joint Select Committee on Deficit Reduction, the “Super Committee” tasked with Identifying $1.2 to $1.5 trillion in additional cuts
***Failure to do so would lead to automatic cuts starting, 50% defense/50% non-defense
***Excluded Medicaid, Social Security, and Medicare Beneficiaries. Provider cuts limited to 2%
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The Sequester
“[Congress] and the administration knew that this sequester would be destructive…. [T]he sequester wasn’t meant to be implemented….
“[N]o amount of planning or reports will turn the sequester into anything other than the devastating cut in defense and domestic investments that it was meant to be.”
Jeffrey Zients, acting director, Office of Management and Budget, Politico, 7/10/12
Nonetheless, it is the law
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The Sequester
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Explicit Challenges
37 http://nexus.od.nih.gov/all/2013/03/04/nih-operations-under-the-sequester/
Rock TalkHelping connect you with the NIH perspective
NIH Operations Under the SequesterPosted on March 4, 2013 by Sally Rockey
Dear NIH Signing Official,As you are likely aware, in accordance with the Budget Control Act of 2011, a series of spending cuts, called sequestration, will cancel approximately $85 billion in budgetary resources across the Federal government for the remainder of the Federal fiscal year. As a partner with you in accomplishing the NIH mission, we are writing to provide you with information about what this reduction means for the funds provided to your organization.
At this time, the Department of Health and Human Services and NIH are taking every step to mitigate the effects of these cuts, but based on our initial analysis, it is possible that your grants or cooperative agreement awards may be affected. Examples of this impact could include: not issuing continuation awards, or negotiating a reduction in the scope of your awards to meet the constraints imposed by sequestration. Additionally, plans for new grants or cooperative agreements may be re-scoped, delayed, or canceled depending on the nature of the work and the availability of resources.
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Explicit Challenges
38 Per Diane J. Frasier: Head of the Contracting Activity, NIH
Sequestration notice sent out to all NIH ContractorsMonday March 04, 2013
To All NIH Contractors:
…”it is possible that your contract(s) may be affected. Examples of this impact could include: not exercising an option on your contract(s); or negotiating lower prices or other terms via a bilateral modification to meet the constraints imposed by sequestration. Additionally, plans for new contract(s) may be re-scoped, delayed, or canceled depending on the nature of the work and the availability of resources.”
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The Elephant
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Our Failing Business Models
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What to expect in times of reduced funding Fewer dollars especially for Institute Initiated Programs
(substantial cuts to contracts) Necessity to be creative (large simple trials/EMR) Critical assessment of how and what is funded
INTERMACS Strengthening the Public Private Partnership Improving Quality Systems Streamlining Regulatory Activities Leveraging Resources and Partnerships Thinking Outside the Box
The New Normal
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Explicit Challenges
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The U.S. system for funding research was designed to function well in times of growth. It is failing now because the system as a whole is contracting. Much of today’s proposal pressure is caused by underfunded investigators who must compete for multiple grants to survive professionally. Such scientists have little time or incentive to be innovative. What is to be done? The funding agencies must admit that it is not humanly possible to predict, with high accuracy, which research projects ultimately will have the most impact. When there are too many of these, as at present, the agencies must find other ways to decide which to support. That will be hard.
Langer J. Science 2012; 388:171INTERMACS Annual
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Even More Explicit
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With 10 to 15% paylines at some institutes (or even less), the current situation makes grant evaluation nearly impossible and is putting truly excellent laboratories out of business. In the spirit of “never waste a good crisis,” a serious evaluation of many NIH extramural policies and programs is warranted. They include centers and other large collective funding efforts as well asexpensive clinical and epidemiological research.
Rosbash M. Science 2011; 333:136INTERMACS Annual
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In Progress: Comparisons on Percentiles
45
Percentile
Cites/$M
Thanks to Simhan Danthi, Colin Wu, and Peibei Shi
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Panel Discussion: FDAAnchal Kaushiva
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FDA Perspective on INTERMACS
Anchal Kaushiva, M.S.Division of Cardiovascular Devices
Office of Device EvaluationFood and Drug Administration
INTERMACS Annual MeetingApril 5-6, 2013
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FDA Center for Devices
Center for Devices(CDRH)
ODE(Pre-market Device
Evaluation)
Division of Epidemiology
(Post-approval studies)
OSB(Surveillance and
Biometrics)
Division of Post-marketSurveillance
(MDRs)
OC(Compliance/Inspections)
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INTERMACS Utility to FDA
• Has been used for post-approval studies
• Served as the concurrent control for a pre-market study
• Provides MDR reports on behalf of user facilities– Has allowed for detection of adverse event signals
• Provides quarterly reports of the data collected
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INTERMACS Accomplishments• Adverse Event Definitions
• Creation of INTERMACS patient profiles
• Data collection has tracked: – Evolution of MCSD technology– Patient risk profiles– Patient outcomes
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Challenges of Using INTERMACS Registry Data for FDA
• Data Quality
• Data Access
• Data Collected
• MDR Reporting
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Data Quality• For the registry to support a clinical study,
FDA would need to review the data management plan and data monitoring plan
• Missing data– Need to know what and how much data is missing
• Adverse event adjudication at a subset of sites would be ideal
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Data Access
For use as a control arm in a pre-market study, access to patient line item data is essential
• Comparative analyses – Patient ID number or date implanted– Site or regional identifiers
• Office of Compliance audits
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Data Collected
• For use in clinical trials, the inclusion and exclusion criteria need to be aligned
• Data points collected in the registry need to be aligned with those collected in the trial
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MDR Reporting
• Use of FDA patient and device problem codes would make reports more useful
• ‘Other’ problem code is difficult to interpret
• Timeline of submission
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Potential Future Uses of INTERMACS
• Continuing to better understand the bridge-to-decision patient population
• Can INTERMACS be used as a concurrent control or performance goal for an “all comers” trial?
• Collecting more information on device malfunctions and quality of life
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Panel Discussion: ClinicalEduardo Rame
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J. Eduardo Rame MD MPhilMCSD Program
University of Pennsylvania
INTERMACS THEN AND NOW: CLINICAL PERSPECTIVE
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THE FIRST: DeBakey 1966
DeBakey ME. Left ventricular bypass pump for cardiac assistance: clinical experience. Am J Cardiol 1971;27:3–11
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THE EXTRAORDINARY: Frazier 1994
• Long-Term Application of a V-E HeartMate LVAD• 33 year old man with end-stage IDCM• 505 Days of Circulatory Support• Untethered Freedom – “enabled patient the
Possibility to eat in restaurants, go to movies, and practice basketball shots.”
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THE EXPECTED
Implantable
Pump
Controller
PercutaneousLead
Batteries INTERMACS Annual
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Thomas Carlyle
“Our main business is not to see what lies dimly at a distance but to do what is clearly at hand.” INTERMACS Annual
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:Confidence in Real-World Practice
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:Tracking Changes in the Practice of MCS
* Cardiovascular includes RHF, VT/VF, Cardiogenic Shock** Other is primarily Multi-organ system failure
Adapted from Intermacs: Federal Partners Quarterly Reports 2008 /2012
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0102030405060708090
100
0 3 6 9 12 15 18 21 24Months Post Implant
% S
urvi
val
Event: Death (censored at Transplant and Explant due to Recovery
High Risk:“Risk Factors”: BiVAD, Cancer, BMI>32, BUN > 50, Dialysis, Age > 75 yrsN=334, deaths=67
Medium Risk: “Risk Factors”=No; Prior Card Surg=YesN=167, deaths=31
p (Low Risk v Others) = 0.06
Months % SurvivalPost implant High Medium Low 6 83% 88% 94% 12 77% 81% 89% 24 72% 65% 80%
Continuous Flow LVAD* Destination TherapyWith INTERMACS Levels 3-7, n= 613
June 2006 – December 2011: “Low Risk DT” –ROADMAP to REVIVE-IT
Low Risk: “Risk Factors” = No; Prior Card Surg = No n=112, deaths=12
p (overall) = 0.13
James Kirklin, J. Thorac Cardiovasc Surg May 2012
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UnderweightNormal
Obese Class II
OverweightObese Class I
Obese Class III
LOG RANK p = 0.82
UNADJUSTED SURVIVAL
:Expanding Patient Eligibility
Donnelly, et al. Does the Obesity Paradox Fade After MCS, ISHLT 2011
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J. Eduardo Rame, Circulation June 2012
Transition to MCS in Heart Failure : MEDAMACS to INTERMACS
: Future Expectations
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Panel Discussion: IndustryDon Middlebrook, Thoratec
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7373
INTERMACS Seventh Annual Meeting New Data, New Thoughts, New Directions
INTERMACS: Accomplishments and Challenges
Donald A. MiddlebrookVice President, Corporate Quality, Regulatory and Clinical Affairs
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INTERMACS: Accomplishments and Challenges
ACCOMPLISHMENTS:• INTERMACS has become a premier source of clinical outcomes data• Well positioned now to remain self-sustaining• Database now accounts for more than 7,700 prospective implants• Rich source for MCS device publications now and in the future• Standardization of Adverse Events remains an important achievement• Thoratec has completed two large post market studies using INTERMACS:
– BTT Conditional Approval study completed and accepted by FDA– DT Conditional Approval study completed and currently under
review by FDA• Established potential for use in future prospective device trials
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INTERMACS: Accomplishments and Challenges
Challenges:• Data compliance and completeness (All implants, outcomes and AEs at all
INTERMCS participating centers)• “Limited dataset” does not provide manufacturers with enough information to
match patient and AEs to internal databases• Device malfunction reporting could become an issue given variety of MCS devices
and complexity of each system• How to provide the most useful information back to meet the needs of
participating centers• Keeping INTERMACS as “a minimum dataset necessary to characterize the safety
and performance of MCS devices in a commercial setting” given ever growing desire for more information
• Ensuring adequate resources available to maintain data quality at highest possible level as registry expands (IMACS, PediMacs, MediMacs etc.)
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INTERMACS Data Collection: Expansions & ClarificationsKathryn Hollifield
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Interagency Registry for Mechanically Assisted Circulatory Support
Clinical AffairsINTERMACS Annual
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Coordinator Training Session, April 05, 2013
Nurse Monitors
Kathryn Hollifield, BSN, RN
Gail Mertz, BS, RN, CCRC
Tammy Davis, BS, RN
Janella Miller, BSN, RN
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Site Compliance
2010=69% > 90% Compliance 2012=85%> 90% Compliance
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Patient Transfers
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Coordinator Training Session, April 05, 2013
Patient TransfersSending Institution
Ensure All Forms and Visits Have Been Completed
Date of last contact, whether by phone or office visit, is the patient transfer date.
Complete Patient Registry Status Form
Receiving Institution
Patient must agree to continued participation in INTERMACS at the new institution
Receiving institution must have IRB approval for Protocol Version 3.0
Obtain “Patient Authorization for INTERMACS to Release Information Consent” at the receiving institution. This located in Appendix C on the INTERMACS website.
Obtain INTERMACS Registry Consent Form at receiving institution.
Please forward copies of both consents to Mary Lynne Clark at the INTERMACS DCC
Receiving institution must verify patient’s date of birth, implant date, gender and race before the patient can be transferred.
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PATIENT REGISTRY STATUS FORM
To be completed by the sending institution, after all the patients forms and visits have been completed. The Receiving hospital will have ‘read only’ access to the pre-transfer records.
To access Patient Registry Status Form
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Reminder: All forms must be completed and submitted, for the transfer process to be completed.
Coordinator Training Session, April 05, 2013
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Patient Transfer Successful!
Coordinator Training Session, April 05, 2013
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Device Exchange
Coordinator Training Session, April 05, 2013
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Click here, after 1) All follow-up
forms have been submitted
2) Explant Form has been completed
Coordinator Training Session, April 05, 2013
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Incomplete form, it is not going to work!
Coordinator Training Session, April 05, 2013
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EXPLANT
Device malfunction
Infection
Device Thrombosis
Other, Specify
Expanded Options
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After you click ‘Add A Device’ you must complete an updated pre-implant for this new device. On the implant form if you only have an RVAD for a device type option, and this is for an LVAD device exchange, then you most likely have a follow-up form due. Be mindful of the visit windows.
Device Exchange
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Events/Form Lag Time
• INTERMACS is a prospective Registry
• All data needs to be entered “As it Happens”
• Generally, within 7 days and always within 30 days.
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Coordinator Training Session, March 11, 2012
QUESTIONS?
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Coordinator Training Session, March 11, 2012
Please complete the Evaluation Form
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Waiver of Consent: Is it Possible?Wendy Taddei-Peters
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Waiver of Consent: Is It Possible?
Wendy Taddei-Peters, Ph.D.Clinical Trial Specialist
National Heart, Lung, and Blood Institute
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I have no relevant financial relationships to disclose.
Disclosure
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Informed Consent has been required since the establishment of the registry because not all INTERMACS® procedures were considered standard of care when the registry was established (e.g., quality of life questionnaires, functional capacity testing).
INTERMACS® was originally introduced as a prospective research registry.
INTERMACS® Background
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Written informed consent cannot be obtained from approximately 12% of MCSD-implanted patients, which may skew the data and undermine the goals of the registry (OSMB Report, August 17, 2012): Patient refused to consent (5%) Patient not approached (4%) Patient too sick to approach (3%) Patient did not speak English/Other (0.3%)
Reason to Obtain Waiver of Consent
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Short name for “The Federal Policy for the Protection of Human Subjects”, adopted by a number of Federal Agencies in 1991.
The Department of Health and Human Services (HHS) made this policy into a regulation - 45 CFR Part 46, Subpart A.
The Common Rule
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Applies to human subjects research conducted, supported, and subject to regulation by Federal Agencies
Describes the types of research subject to regulation
Defines key terms such as research, human subject, and minimal risk
Requires written assurance of compliance with the common rule in the form of a Federal Wide Assurance (FWA)
The Common Rule (cont’d)
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Sets forth requirements for an IRB’s membership, authority, review procedures, records and criteria for approval
Lists the general requirements for informed consent
Allows for waiver of consent under specific circumstances
The Common Rule (cont’d)
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An IRB may . . . waive the requirement to obtain informed consent provided the IRB finds and documents that:(1) The research project is . . . designed to study,
evaluate, or otherwise examine:(i) Public Benefit or service programs(ii) Procedures for obtaining benefits or
services under those programs
45 CFR 46.116(c)
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(iii) Possible changes in or alternatives to those programs or
procedures; or(iv) possible changes in methods or levels
of payment for benefits or services under those programs; and (2) The research could not practicably be carried
out without a waiver or alteration.
45 CFR 46.116(c) (cont’d)
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An IRB may . . .waive the requirements to obtain informed consent provided the IRB finds and documents that:(1) The research involves no more than minimal risk to
the subjects;(2) The waiver or alternation will not adversely affect the
rights and welfare of the subjects;(3) The research could not practicably be carried out
without the waiver or alteration; and (4) Whenever appropriate, the subjects will be provided
with additional pertinent information after participation.
45 CFR 46.116(d)
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CMS mandated that one of the conditions for hospital certification as a destination therapy center is that the hospital be an active, continuous member of INTERMACS® in March 2007.
Written consent cannot be obtained from critically ill patients (or their legally authorized representative) who undergo emergent MCSD implantation and/or die within the first 24-48 hours.
Justification for Waiver of Consent
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Participation in the registry is of minimal risk and will not negatively impact the welfare of patients.
The information gained from this registry is of great value to the public as compared to the low risk faced by patients.
The registry collects data primarily through medical record abstraction (retrospectively).
Justification for Waiver (cont’d)
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Follow-up examinations, evaluations, and interviews have become or should be considered as the standard of care now that INTERMACS® is in its 8th year of existence.
The data collected for this registry are for quality improvement purposes.
Any potential research studies must be approved by INTERMACS® leadership and will use de-identified datasets unless written informed consent is obtained.
Justification for Waiver (cont’d)
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Waiver of Consent is clearly possible and needed to capture all patients receiving FDA-approved MCSDs.
NHLBI is in the process of completing Protocol Version 4.0, the accompanying manual of operations, and justification for waiver in collaboration with the DCC and independent OSMB and anticipates completion in Summer 2013.
Conclusion and Status
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The Latest Hospital Quarterly QA Report: An Evaluation Tool for Local Programs
David C. Naftel
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Hospitals• What services do the hospitals receive for their
participation fee?• Services
• Meets CMS/Joint Commission requirement for Destination Therapy Certification
• Meets FDA required submission of Medical Device Reports (MDRs) by hospitals
• Provides clinical summaries of patients• Provides quality assurance reports• Provides electronic data transfer• Provides standardized datasets• Provides benchmarking• Provides training and continuing education units
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Hospitals (Continued)
• What benefits do the hospitals receive for their participation fee?• Benefits
• Become part of the national dialogue on the evaluation and evolution of MCSDs
• Invited to participate in the INTERMACS Annual Meeting
• Invited to join the INTERMACS Committees• Coordinators Council and other committees
• Select Hospital Administrators will have the opportunity to serve on the Business Advisory Committee
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Quarterly Quality Assurance Report • One of the benefits for participating in
INTERMACS• These reports have evolved through the
years• These reports provide benchmark
statistics• These reports are a good mechanism for
the local VAD team to visualize and understand the outcomes of their patients
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INTERMACS and the Joint Commission• Will be discussed tomorrow by Dr.
Kormos• We have modified our reports to be more
useful to the local hospital for the DT certification process
• We are anxious to continue to work with the Joint Commission and the local hospitals to provide useful reports
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Seventh Annual Meeting, April 5-6, 2013
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Seventh Annual Meeting, April 5-6, 2013
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Seventh Annual Meeting, April 5-6, 2013
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Seventh Annual Meeting, April 5-6, 2013
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1. May 31, 2007 Minor revisions to web-based data entry (Protocol v2.2)
2. March 5, 2009 Significant form revision (e.g. bleeding form - Protocol v2.3)
3. May 2, 2012 INTERMACS Re-Launch (Protocol v3.0)
INTERMACS Form Revisions
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Workshop for the Executive Committee, FDA, and Industry
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Seventh Annual Meeting, April 5-6, 2013
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Seventh Annual Meeting, April 5-6, 2013
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Seventh Annual Meeting, April 5-6, 2013
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Seventh Annual Meeting, April 5-6, 2013
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Seventh Annual Meeting, April 5-6, 2013
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Seventh Annual Meeting, April 5-6, 2013
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Seventh Annual Meeting, April 5-6, 2013
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Future Changes:• Add screening summary• Provide summaries of non-primary
patients• Produce summaries for only continuous
flow pumps• Enhancements directed towards Joint
Commission requirements• Separate report for pediatric patients
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Data Quality ReportThis report is a mechanism for the site to see patient level data, including events, deaths and follow-up for each patient included in the report. The INTERMACS auditors use this report to identify data inconsistencies and incomplete data.
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Seventh Annual Meeting, April 5-6, 2013
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INTERMACS AwardsJames Young
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2013 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• Univ. of Alabama at Birmingham, Birmingham, AL• Baptist Health Medical Center, Little Rock, AR• Mayo Clinic Hospital, Phoenix, AZ• Cedars Sinai Medical Center, Los Angeles, CA• Sutter Memorial Hospital, Sacramento, CA• Sharp Memorial Hospital, San Diego, CA• Stanford University Medical Center, Stanford, CA• Univ. of Colorado Hospital, Aurora, CO
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Vanguard Centers• Yale-New Haven Hospital, New Haven, CT• Mayo Clinic Hospital, Jacksonville, FL• Emory University Hospital, Atlanta, GA• Piedmont Hospital, Atlanta, GA• St. Joseph's Hospital of Atlanta, Atlanta, GA• Loyola University Medical Center, Maywood, IL• Northwestern Memorial Hospital, Chicago, IL• Methodist Hospital, Indianapolis, IN
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Vanguard Centers• Jewish Hospital, Louisville, KY• Brigham and Women's Hospital, Boston, MA• Henry Ford Hospital, Detroit, MI• Univ. of Michigan Health System, Ann Arbor, MI• Mayo Clinic Hospital - St. Mary's, Rochester, MN• Univ. of Minnesota Medical Center - Fairview, Minneapolis, MN• Duke Univ. Medical Center, Durham, NC• Univ. of Minnesota Medical Center - Fairview, Minneapolis, MN
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Vanguard Centers• Duke Univ. Medical Center, Durham, NC• Univ. of Nebraska Medical Center, Omaha, NE• Barnabas Health, Newark, NJ• Morristown Memorial Hospital Atlantic Health Morristown, NJ• Robert Wood Johnson Univ., New Brunswick, NJ• Columbia Univ. Medical Center-NY Presbyterian, New York, NY• Univ. of Rochester MC - Strong Memorial Hosp., Rochester, NY• Montefiore Medical Center, Bronx, NY
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Vanguard Centers• Weill Cornell MC- New York Presbyterian MC, New York, NY• Cleveland Clinic Foundation, Cleveland, OH• The Christ Hospital, Cincinnati, OH• Integris Baptist Medical Center, Oklahoma City, OK• Oregon Health & Sciences Univ., Portland, OR• Penn State Milton S. Hershey Medical Center, Hershey, PA• Univ. of Pittsburgh Medical Center, Pittsburgh, PA• Temple Univ. Hospital, Philadelphia, PA• Hospital of the Univ. of Pennsylvania, Philadelphia, PA
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Vanguard Centers• St. Thomas Hospital, Nashville, TN• Seton Medical Center, Austin, TX• St. Luke's Episcopal Hosp. - Texas Heart Institute Houston, TX• UT Southwestern Medical Center, Dallas, TX• Inova Fairfax Hospital, Falls Church, VA• Sentara Norfolk General Hospital, Norfolk, VA• Inland NW Thoracic Organ Transplant Program, Spokane,
WA• St. Luke's Medical Center, Milwaukee, WI
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