Presentation is loading. Please wait.

Presentation is loading. Please wait.

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.

Similar presentations


Presentation on theme: "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."— Presentation transcript:

1 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

2 Financial Disclosure INTERMACS SpeakerCompany AffiliationRelationship Francis Pagani, MDHeartWareResearch Support David Naftel, PhDHeartWare, ThoratecConsultant Don MiddlebrookThoratecEmployee David Hathaway, MDHeartWareEmployee 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 2 INTERMACS Annual Meeting, April 2013

3 Session 1 Friday, April 5 5:30pm – 9:00pm 3 5:30 Registration/Dinner 6:00 Welcome 6:10 INTERMACS: Accomplishments & Challenges 7:00 INTERMACS Data Collection: Expansions & Clarifications 7:30 Break 7:45 Waiver of Consent: Is it Possible? 8:00 The Latest Hospital Quarterly QA Report: An Evaluation Tool for Local Programs 8:45 INTERMACS Awards INTERMACS Annual Meeting, April 2013

4 Welcome James Young 4 INTERMACS Annual Meeting, April 2013

5 INTERMACS: Accomplishments & Challenges James Kirklin 5 INTERMACS Annual Meeting, April 2013

6 Original Contract May 31, 2005 – May 30, 2010 Contract Extension May 31, 2010 – November 30, 2010 Latest Contract December 1, 2010 – November 30, 2015 6 INTERMACS Annual Meeting, April 2013

7 Original Contract and Deliverables May 31, 2005 – May 30, 2010 (Highlights) Article C.1. Statement of Work 7 INTERMACS Annual Meeting, April 2013

8 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 8 INTERMACS Annual Meeting, April 2013

9 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 9 INTERMACS Annual Meeting, April 2013

10 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 10 INTERMACS Annual Meeting, April 2013

11 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 11 INTERMACS Annual Meeting, April 2013

12 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 12 INTERMACS Annual Meeting, April 2013

13 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 13 INTERMACS Annual Meeting, April 2013

14 Contract Extension Deliverables May 31, 2010 – November 31, 2010 14 INTERMACS Annual Meeting, April 2013

15 Latest Contract and Deliverables December 1, 2010 – November 31, 2015 (Highlights) 15 INTERMACS Annual Meeting, April 2013

16 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 16 INTERMACS Annual Meeting, April 2013

17 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 investigators 9.Prepare and distribute quarterly reports for sites including patient recruitment, status of follow-up, data compliance, etc. 10.Quarterly individualized industry data reports 17 INTERMACS Annual Meeting, April 2013

18 11. Semi-annual progress reports of the registry 12. Plan and conduct annual conference 13. Prepare interim limited data sets consistent with NHLBI policies 14. Six months before end of contract, provide a final copy of de-identified data in hard copy and computerized disc formats along with support documents 15. Conduct site visits to 100% of sites. Perform record audits to determine accuracy of WBDE and conduct for-cause visits/audits as needed 16. Work with sites and investigators to prepare abstracts and manuscripts 17. Extend research collaborations beyond the current INTERMACS investigators 18. 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 18 INTERMACS Annual Meeting, April 2013

19 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 Support December 1, 2010 – March 29, 2013 19 INTERMACS Annual Meeting, April 2013

20 COST SHARING REPORT December 1, 2010 – March 29, 2013 20 INTERMACS Annual Meeting, April 2013

21 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, 2012INTERMACS Re-Launch (Protocol v3.0) INTERMACS Form Revisions 21 Workshop for the Executive Committee, FDA, and Industry INTERMACS Annual Meeting, April 2013

22 1.Quality Assurance Reports 2.Medical Device Reports 3.Medical Event Review Additional Initiatives 22 INTERMACS Annual Meeting, April 2013

23 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 results for the term INTERMACS: 1,33 0 INTERMACS Annual Meeting, April 2013

24 # of abstracts/publications 24 Publications June 2006 - March 2013 Year 48 18 (Thru March) INTERMACS Annual Meeting, April 2013

25 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. 25 INTERMACS Annual Meeting, April 2013

26 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 4 INTERMACS Annual Meeting, April 2013

27 Pre- and Post Market Studies Using INTERMACS Summary Post Market Studies Thoratec, HMII BTT Post Market Study complete Nov 2011 Results confirm pivotal trial Thoratec, HMII DT Post Market Study will be complete 2013 Pre-Market Studies Berlin Heart, EXCOR Pre-MarketFDA Approval 12/16/2011 (INTERMACS provided statistical support) Heartware, HVAD Pre-Market FDA Approval 11/20/2012 27 Workshop for the Executive Committee, FDA, and Industry INTERMACS Annual Meeting, April 2013

28 The ‘MACS’ Family INTERMACS o INTERMACS: Adults o pediMACS: Pediatric o CanaMACS: Adults + Pediatric IMACS (ISHLT Initiative) MEDAMACS (Medically treated patients) JMACS BENEMACS 28 INTERMACS Annual Meeting, April 2013

29 29 Seventh Annual Meeting, April 5-6, 2013 INTERMACS MedaMACS PediMACS U-MACS IMACS INTERMACS Annual Meeting, April 2013

30 30 Seventh Annual Meeting, April 5-6, 2013 Partnerships Federal Partners – FDA, CMS, NHLBI Industry Member Institutions/Centers INTERMACS Annual Meeting, April 2013

31 Panel Discussion: NIH Marissa Miller 31 INTERMACS Annual Meeting, April 2013

32 A Dialogue on Current Budget Challenges and Their Impact on INTERMACS Marissa A. Miller, DVM, MPH Chief, Advanced Technologies and Surgery Branch National Heart, Lung, and Blood Institute Financial disclosures: None INTERMACS Annual Meeting April 5, 2013 INTERMACS Annual Meeting, April 2013

33

34 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% INTERMACS Annual Meeting, April 2013

35 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 INTERMACS Annual Meeting, April 2013

36 The Sequester 36 INTERMACS Annual Meeting, April 2013

37 Explicit Challenges 37 http://nexus.od.nih.gov/all/2013/03/04/nih-operations-under-the-sequester/ Rock Talk Helping connect you with the NIH perspective NIH Operations Under the Sequester Posted on March 4, 2013 by Sally Rockey March 4, 2013Sally 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. INTERMACS Annual Meeting, April 2013

38 Explicit Challenges 38 Per Diane J. Frasier: Head of the Contracting Activity, NIH Sequestration notice sent out to all NIH Contractors Monday 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.” INTERMACS Annual Meeting, April 2013

39 The Elephant 39 INTERMACS Annual Meeting, April 2013

40 Our Failing Business Models 40 INTERMACS Annual Meeting, April 2013

41  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 41 INTERMACS Annual Meeting, April 2013

42 42 INTERMACS Annual Meeting, April 2013

43 Explicit Challenges 43 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; 388:171 INTERMACS Annual Meeting, April 2013

44 Even More Explicit 44 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 as expensive clinical and epidemiological research. Rosbash M. Science 2011; 333:136 INTERMACS Annual Meeting, April 2013

45 In Progress: Comparisons on Percentiles 45 Percentile Cites/$M Thanks to Simhan Danthi, Colin Wu, and Peibei Shi INTERMACS Annual Meeting, April 2013

46 Panel Discussion: FDA Anchal Kaushiva 46 INTERMACS Annual Meeting, April 2013

47 FDA Perspective on INTERMACS Anchal Kaushiva, M.S. Division of Cardiovascular Devices Office of Device Evaluation Food and Drug Administration INTERMACS Annual Meeting April 5-6, 2013 47 INTERMACS Annual Meeting, April 2013

48 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-market Surveillance (MDRs) OC (Compliance/Inspections) INTERMACS Annual Meeting, April 2013

49 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 INTERMACS Annual Meeting, April 2013

50 INTERMACS Accomplishments Adverse Event Definitions Creation of INTERMACS patient profiles Data collection has tracked: –Evolution of MCSD technology –Patient risk profiles –Patient outcomes Expansion to PediMACS, MedaMACS, IMACS INTERMACS Annual Meeting, April 2013

51 Challenges of Using INTERMACS Registry Data for FDA Data Quality Data Access Data Collected MDR Reporting INTERMACS Annual Meeting, April 2013

52 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 INTERMACS Annual Meeting, April 2013

53 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 INTERMACS Annual Meeting, April 2013

54 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 INTERMACS Annual Meeting, April 2013

55 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 INTERMACS Annual Meeting, April 2013

56 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 INTERMACS Annual Meeting, April 2013

57 Contact Information for Questions anchal.kaushiva@fda.hhs.gov INTERMACS Annual Meeting, April 2013

58 Panel Discussion: Clinical Eduardo Rame 58 INTERMACS Annual Meeting, April 2013

59 J. Eduardo Rame MD MPhil MCSD Program University of Pennsylvania INTERMACS THEN AND NOW: CLINICAL PERSPECTIVE INTERMACS Annual Meeting, April 2013

60 THE FIRST: DeBakey 1966 DeBakey ME. Left ventricular bypass pump for cardiac assistance: clinical experience. Am J Cardiol 1971;27:3–11 INTERMACS Annual Meeting, April 2013

61 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.” INTERMACS Annual Meeting, April 2013

62 THE EXPECTED Implantable Pump Controller Percutaneous Lead Batteries INTERMACS Annual Meeting, April 2013

63 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 Meeting, April 2013

64 : Confidence in Real-World Practice INTERMACS Annual Meeting, April 2013

65 : 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 INTERMACS Annual Meeting, April 2013

66 Months Post Implant % Survival Event: Death (censored at Transplant and Explant due to Recovery High Risk: “Risk Factors”: BiVAD, Cancer, BMI>32, BUN > 50, Dialysis, Age > 75 yrs N=334, deaths=67 Medium Risk: “Risk Factors”=No; Prior Card Surg=Yes N=167, deaths=31 p (Low Risk v Others) = 0.06 Months % Survival Post implantHigh Medium Low 6 83%88%94% 12 77%81%89% 24 72%65%80% Continuous Flow LVAD* Destination Therapy With 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 INTERMACS Annual Meeting, April 2013

67 Underweight Normal Obese Class II Overweight Obese 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 INTERMACS Annual Meeting, April 2013

68 J. Eduardo Rame, Circulation June 2012 Transition to MCS in Heart Failure : MEDAMACS to INTERMACS : Future Expectations INTERMACS Annual Meeting, April 2013

69 : Expanding Patient Eligibility INTERMACS Annual Meeting, April 2013

70 EQ-5D VAS (N=186) Pre-Implant3 month6 month12 month (N=654) (N=398) (N=345) P (pre vs 3 mo) < 0.0001 Months Post Implant Best Worst EQ5D Visual Analog Scale (VAS) across time (mean ± SE) CF LVAD*, n=1160 P (pre vs 6 mo) < 0.0001 P (pre vs 12 mo) = 0.0002 Quality of Life in Destination Therapy –Early and Sustained Increase James Kirklin, J. Thorac Cardiovasc Surg May 2012 INTERMACS Annual Meeting, April 2013

71 Acknowledgement Michael Acker Joe Woo Pavan Atluri Mariell Jessup Sue Brozena Ken Margulies Lee Goldberg Tom Cappola Joyce Wald Anjalie Owens Paul Forfia Daniel Dries David Naftel Susan Myers Mary Lou O’Hara Judy Marble Cristyna Zalewski Sheri Walsh Crissy Hill INTERMACS Annual Meeting, April 2013

72 Panel Discussion: Industry Don Middlebrook, Thoratec 72 INTERMACS Annual Meeting, April 2013

73 73 INTERMACS Seventh Annual Meeting New Data, New Thoughts, New Directions INTERMACS: Accomplishments and Challenges Donald A. Middlebrook Vice President, Corporate Quality, Regulatory and Clinical Affairs INTERMACS Annual Meeting, April 2013

74 74 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 INTERMACS Annual Meeting, April 2013

75 75 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.) INTERMACS Annual Meeting, April 2013

76 INTERMACS Data Collection: Expansions & Clarifications Kathryn Hollifield 76 INTERMACS Annual Meeting, April 2013

77 Interagency Registry for Mechanically Assisted Circulatory Support Clinical Affairs INTERMACS Annual Meeting, April 2013

78 Coordinator Training Session, April 05, 2013 Nurse Monitors 78 INTERMACS Annual Meeting, April 2013

79 Site Compliance 2010=69% > 90% Compliance2012=85%> 90% Compliance INTERMACS Annual Meeting, April 2013

80 Patient Transfers INTERMACS Annual Meeting, April 2013

81 Coordinator Training Session, April 05, 2013 Patient Transfers Sending 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. 29 INTERMACS Annual Meeting, April 2013

82 Coordinator Training Session, April 05, 2013 82 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 INTERMACS Annual Meeting, April 2013

83 Reminder: All forms must be completed and submitted, for the transfer process to be completed. Coordinator Training Session, April 05, 2013 INTERMACS Annual Meeting, April 2013

84 Patient Transfer Successful! INTERMACS Annual Meeting, April 2013

85 Device Exchange Coordinator Training Session, April 05, 2013 INTERMACS Annual Meeting, April 2013

86 Click here, after 1)All follow-up forms have been submitted 2)Explant Form has been completed Coordinator Training Session, April 05, 2013 INTERMACS Annual Meeting, April 2013

87 Incomplete form, it is not going to work! Coordinator Training Session, April 05, 2013 INTERMACS Annual Meeting, April 2013

88 Coordinator Training Session, April 05, 2013 88  Device malfunction  Infection  Device Thrombosis  Other, Specify Expanded Options INTERMACS Annual Meeting, April 2013

89 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 INTERMACS Annual Meeting, April 2013

90 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. INTERMACS Annual Meeting, April 2013

91 Coordinator Training Session, March 11, 2012 QUESTIONS? 91 INTERMACS Annual Meeting, April 2013

92 Coordinator Training Session, March 11, 2012 92 INTERMACS Annual Meeting, April 2013

93 Waiver of Consent: Is it Possible? Wendy Taddei-Peters 93 INTERMACS Annual Meeting, April 2013

94 Waiver of Consent: Is It Possible? Wendy Taddei-Peters, Ph.D. Clinical Trial Specialist National Heart, Lung, and Blood Institute INTERMACS ® Seventh Annual Meeting April 5, 2013 INTERMACS Annual Meeting, April 2013

95 I have no relevant financial relationships to disclose. Disclosure 95 INTERMACS Annual Meeting, April 2013

96  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 96 INTERMACS Annual Meeting, April 2013

97  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 97 INTERMACS Annual Meeting, April 2013

98  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 98 INTERMACS Annual Meeting, April 2013

99  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) 99 INTERMACS Annual Meeting, April 2013

100  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) 100 INTERMACS Annual Meeting, April 2013

101  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) 101 INTERMACS Annual Meeting, April 2013

102 (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) 102 INTERMACS Annual Meeting, April 2013

103  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) 103 INTERMACS Annual Meeting, April 2013

104  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 104 INTERMACS Annual Meeting, April 2013

105  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) 105 INTERMACS Annual Meeting, April 2013

106  Follow-up examinations, evaluations, and interviews have become or should be considered as the standard of care now that INTERMACS ® is in its 8 th 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) 106 INTERMACS Annual Meeting, April 2013

107  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 107 INTERMACS Annual Meeting, April 2013

108 108 INTERMACS Annual Meeting, April 2013

109 The Latest Hospital Quarterly QA Report: An Evaluation Tool for Local Programs David C. Naftel 109 INTERMACS Annual Meeting, April 2013

110 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 INTERMACS Annual Meeting, April 2013

111 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 INTERMACS Annual Meeting, April 2013

112 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 112 INTERMACS Annual Meeting, April 2013

113 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 113 INTERMACS Annual Meeting, April 2013

114 Seventh Annual Meeting, April 5-6, 2013 114 INTERMACS Annual Meeting, April 2013

115 Seventh Annual Meeting, April 5-6, 2013 115 INTERMACS Annual Meeting, April 2013

116 Seventh Annual Meeting, April 5-6, 2013 116 INTERMACS Annual Meeting, April 2013

117 Seventh Annual Meeting, April 5-6, 2013 117 INTERMACS Annual Meeting, April 2013

118 1.May 31, 2007Minor revisions to web-based data entry (Protocol v2.2) 2.March 5, 2009Significant form revision (e.g. bleeding form - Protocol v2.3) 3.May 2, 2012INTERMACS Re-Launch (Protocol v3.0) INTERMACS Form Revisions 118 Workshop for the Executive Committee, FDA, and Industry INTERMACS Annual Meeting, April 2013

119 Seventh Annual Meeting, April 5-6, 2013 119 INTERMACS Annual Meeting, April 2013

120 Seventh Annual Meeting, April 5-6, 2013 120 INTERMACS Annual Meeting, April 2013

121 Seventh Annual Meeting, April 5-6, 2013 121 INTERMACS Annual Meeting, April 2013

122 Seventh Annual Meeting, April 5-6, 2013 122 INTERMACS Annual Meeting, April 2013

123 Seventh Annual Meeting, April 5-6, 2013 123 INTERMACS Annual Meeting, April 2013

124 Seventh Annual Meeting, April 5-6, 2013 124 INTERMACS Annual Meeting, April 2013

125 Seventh Annual Meeting, April 5-6, 2013 125 INTERMACS Annual Meeting, April 2013

126 Seventh Annual Meeting, April 5-6, 2013 126 INTERMACS Annual Meeting, April 2013

127 Seventh Annual Meeting, April 5-6, 2013 127 INTERMACS Annual Meeting, April 2013

128 Seventh Annual Meeting, April 5-6, 2013 128 INTERMACS Annual Meeting, April 2013

129 Seventh Annual Meeting, April 5-6, 2013 129 INTERMACS Annual Meeting, April 2013

130 Seventh Annual Meeting, April 5-6, 2013 130 INTERMACS Annual Meeting, April 2013

131 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 131 INTERMACS Annual Meeting, April 2013

132 Data Quality Report This 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. 132 INTERMACS Annual Meeting, April 2013

133 Seventh Annual Meeting, April 5-6, 2013 133 INTERMACS Annual Meeting, April 2013

134 INTERMACS 134 INTERMACS Annual Meeting, April 2013

135 INTERMACS Awards James Young 135 INTERMACS Annual Meeting, April 2013

136 2013 INTERMACS Vanguard Centers Regulatory Compliance = 100% Participated in INTERMACS = 1Year Minimum Enrollment = 20 Patients Data Compliance = 95% Currently Activated 136 INTERMACS Annual Meeting, April 2013

137 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 137 INTERMACS Annual Meeting, April 2013

138 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 138 INTERMACS Annual Meeting, April 2013

139 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 139 INTERMACS Annual Meeting, April 2013

140 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 140 INTERMACS Annual Meeting, April 2013

141 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 141 INTERMACS Annual Meeting, April 2013

142 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 142 INTERMACS Annual Meeting, April 2013


Download ppt "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."

Similar presentations


Ads by Google