1. 7.35PHTS Business DCC Update/QID. Naftel Database CommitteeR. Gajarski (W. Mahle) Foundation UpdateA. Dipchand Financial RoadmapW. Mahle 8:15 Hard to Forget: The Challenge of Desensitization in Heart Transplant Candidates Jon Kobashigawa, MD 8:45PHTS Scientific Committee ReportW. Mahle 8:50Total Artificial Heart in ChildrenTimothy Baldwin, PhD 9:20Maintenance SteroidsS. Auerbach 9:25PVRM. Richmond (W. Mahle) 9:30AdjournW. Mahle

2. The purposes of the group are to establish and maintain an international, prospective, event driven database for heart transplantation, to use the database to encourage and stimulate basic and clinical research in the field of pediatric heart transplantation and to promote new therapeutic strategies.

3. James K. Kirklin, MDCV Division Director David Naftel, PhDProgram Director and Statistician Margaret Tresler, MPHProgrammer and Statistician Rob BrownProgrammer and Statistician Manisha Kukreja, MD, MPH Programmer and Statistician Susanna LendermanProgram Manager DeAnna BeckhamData Entry Manager James George, PhDImmunologist and Researcher Susan MyersProgrammer and Statistician Chase LendermanWebsite Management

4. Study ManagementData Management Site IRBSData Entry Dues CollectionData Checking Finance ManagementData Quality Conference Calls Website ManagementScience Conduct Annual MeetingPIs to UAB Abstracts Annual Report Presentations Summery of DatabasePublications Analysis of each siteMiscellaneous Request

5. April5 presentations at ISHLT June - NovemberISHLT Abstract Analyses October 5-6PI Visit: Scott Auerbach November 4PHTS Annual Fall Meeting November 7AHA Presentations (1) November 16ISHLT Abstract Submission (2)

6. 373Reported by UNOS for all pediatric heart transplants 335Reported by UNOS for PHTS Centers 90%Potential percentage of all US pediatric heart transplants if all PHTS centers report 100% of individual center transplants* 312Reported to PHTS for the calendar year 2011 84%of US transplants *some patients may be ineligible

7. 2011 Pediatric Heart Transplants 35Canadian Transplants Reported to PHTS 23European Transplants Reported to PHTS 58Total non US transplants reported to PHTS 19%Non US center pediatric transplant

8. PHTS Begins First Paper is Published First Form Revision Second Form Revision Third Form Revision Extensive form and data review by Database Committee Fourth Form Revision PHTS Foundation becomes a 501(3)3 nonprofit Collaboration with UNOS 19931996199920052008-20092010 2011

9. Anne and Robert H. Lurie Children’s Hospital of Chicago, Chicago, IL Duke Children’s Hospital, Durham, North Carolina Arkansas Children’s Hospital, Little Rock, ARFreeman Hospital, Newcastle upon Tyne, United Kingdom Cardinal Glennon Children’s Medical Center, St. Louis, MOGreat Ormond Street Hospital for Children, London, UK Children’s Healthcare of Atlanta at Egleston, Atlanta, GAHospital of Sick Children, Toronto, ON Children’s Hospital, Boston, MAJoe Demaggio Children’s Hospital, Hollywood, FL Children’s Hospital Medical Center, Cincinnati, OHJohns Hopkins Hospital, Baltimore, MD Children’s Hospital of Michigan, Detroit, MI Loma Linda University Medical Center, Loma Linda, CA Children’s Hospital of Philadelphia, Philadelphia, PAMedical University of South Carolina, Charleston, SC Children’s Hospital of Pittsburgh, Pittsburgh, PANationwide Children’s Hospital, Columbus, Ohio Children’s Hospital of Wisconsin, Milwaukee, WI Primary Children’s Medical Center, Salt Lake City, UT Cleveland Clinic Foundation, Cleveland, OHRiley Hospital for Children, Indianapolis, IN Columbia University-Babies Hospital, New York, NY

10. Seattle Children’s Medical Center, Seattle, WAUniversity of Florida, Shands Hospital, Gainesville, FL St. Joseph’s Hospital and Medical Center, Phoenix, AZUniversity of Iowa Hospitals and Clinics, Iowa City, IA St. Louis Children’s Hospital, St. Louis, MOUniversity of Miami, Jackson Memorial Hospital, Miami, FL Stanford University Medical Center, Stanford, CAUniversity of Michigan, Mott Children’s Hospital, Ann Arbor, MI Texas Children’s Hospital, Houston, TXUniversity of Minnesota, Amplatz Children’s Hospital, Minneapolis, MN The Children’s Hospital at Montefiore, New York, NYUniversity of North Carolina, Chapel Hill, NC University of Alabama at Birmingham, Birmingham, ALUniversity of South Florida-All Children’s Hospital, St. Petersburg, FL University of Alberta, Edmonton, CanadaUniversity of Texas, Children’s Medical Center, Dallas, TX University of Colorado, The Children’s Hospital, Denver, COUniversity of Virginia, Charlottesville, VA University of California Los Angeles, Los Angeles, CA

11. Listing Data Set Listed patients (January 1, 1993-December 31, 2011) 5,448 Transplanted (January 1, 1993-December 31, 2011) 3,769

12. 20002012 Institutions2142 Patients (listed)16785448* Abstracts1884 Papers753 *Through December 31, 2011

13. Form #NameWhen to Submit 1Patient ListingImmediately after listing 1tPatient TransplantImmediately after transplant 2DonorImmediately after transplant 3ImmunosuppressionSubmit at discharge 4CAD and LV Function AssessmentImmediately after the event 5RejectionImmediately after the event 6InfectionImmediately after the event 7Malignancy/LymphoproliferativeImmediately after the event 8Status ReportImmediately after the event 9Coronary RevascularizationImmediately after the event 10DeathTime of death post-listing/tx 11Re-transplantImmediately after the event 12Pre-transplant Follow-upAt the yearly anniversary of listing date or when removed from list permanently due to death while waiting or transplantation 14Dialysis/Renal TransplantImmediately after the event 15Mechanical Circulatory Support EventsImmediately after the event 16Anti-HLA AntibodiesAt time of transplant or death while waiting (if the patient PRA >10% or had a positive donor specific Crossmatch)

14. What it takes to have analyzable data: 1. Timely submission from institution (critical for the DCC to stay on track for deadline) 2. Data are: a. Received and separated for entry b. Entered by form type c. Entered forms are printed daily d. Forms are checked by two people e. Data entry (DCC) errors are corrected f. Data entry (Institutional) errors are collected and sent back monthly g. Monthly corrections are received back from institution h. Corrections are entered i. Forms are filed

15. To be included in the final research database you must have: 1. Current IRB 2. Current Dues 3. Complete Data a. Listings b. Transplants (reconciled with UNOS) c. Follow-up and Events d. Year End data received by March 1 st What happens if I can’t submit my data by the deadline? Call or email to let us know!!

16. Presentations (1993-2012) SocietyN% of 84 ISHLT5869% AHA1518% ACC030304% IPTA060607% Other020202% Total (Actual)84100%

17. Institution 2011 Listings 2011 TransplantsCorrections Form Questions IRB ApprovalDUA2012 Dues A 1 B C D E F G 13

18. Institution 2011 2011 TransplantsCorrections Form Questions IRB DUA2012 Dues ListingsApproval A 1 B C D E F G 13 H I 219 J 1 K L M N O P 221 1 Q 363 R 223 S 2 T 31 U V 82 W X Y Z AA AB 154 AC 1 AD AE 1 AF 1 AG 11 1 AH 1 AI AJ 61434 1 AK 17 AL AM AN AO 513 AP 1 Not Submitted 614128104230

19. Publications (1993-2012) JournalN% of 53 JHLT3260% Circulation612% Pediatric Transplantation47% Transplantation47% Progress in Pediatric Cardiology12% Lancet12% Congenital Heart Disease12% Pediatric Solid Organ Transplantation12% ISHLT Monograph Series12% Journal of American College of Cardiology12% The American Journal of Transplantation12% Total53100%

20. Susanna Lenderman, Program Manager Office: 205-975-0086 Fax: 205-975-0085 Email: slende@uab.edu DeAnna Beckham, Data Entry Manager Office: 205-975-2864 Fax: 205-975-0085 Email: dbeckham@uab.edu

21. A New Direction for PHTS? A Continuing Evolution of Center Specific Reports?

22. Quality Assurance Quality assurance, or QA (in use from 1973) for short, is the systematic monitoring and evaluation of the various aspects of a project, service or facility to maximize the probability that minimum standards of quality are being attained by the process. (source: wikipedia.com) Quality Improvement The systematic approach to reduction or elimination of waste, rework, and losses in production process. (source: businessdictionary.com) Benchmark noun / ˈ benCH ˌ märk/ a standard by which something can be measured or judged (source: google.onlinedictionary.com)

23. Summarize results at the local hospital Listed Patients Listing characteristics Outcomes: Death, transplant Transplanted Patients Pre-transplant characteristics Outcomes: Death, rejection, infection, malignancy, CAV, re-transplantation, etc.

24. Current Information Security Requirements One point of contact Encrypted files Secure data transfer via password protected drop-box