Annual Fall Meeting November 13, 2016 6:30pm Welcome J. Kirklin/M. Everitt 6:40pm Steering Committee Report M. Everitt 6:50pm DCC Update J. Kirklin 7:05pm Web Based Data Entry D. Naftel 7:20pm Database Committee Report M. Richmond 7:35pm Foundation Update C. Collum/B. Wilk/R. Gajarski 7:50pm Risk Factor Model K. Schumacher 8:05pm Heart Failure Simulation B. Feingold 8:10pm iPHFR R. Gajarski 8:15pm Break 8:30pm Pedimacs Report B. Blume 8:40pm Scientific Committee Report D. Hsu 8:50pm Scientific Committee Sponsored Workshops 9:35pm New Business 9:45pm Adjourn

Registry Comparison Feature PHTS Intermacs Pedimacs Web Based Data Entry System FISMA Compliant Administrative System Manages Data Quality Assurance Reports Annual Quarterly Data Quality Reports De-identified Data to Researchers Patient Lists Version 2 Real-Time Data Checks Download Excel Data Download SAS Research Data Coming Analytics 2016 Outcome Predictions

Web Based Data Entry System Initial Goal Create and implement software for electronic entry of data Expanded Goal Create an electronic system for managing data (entry, quality checks, etc.) for managing participating hospitals and local personnel for communication for document delivery for managing regulatory requirements is FISMA/HIPAA compliant

WBDE System Development at UAB UAB IT Application Consulting Services MedaMACS: Live January 2013 INTERMACS: Live June 2, 2014 PediMACS: Live September 1, 2014 PHTS: Live October 1, 2015 Design and Structure of the WBDE System Will follow INTERMACS (cost savings) FISMA/HIPAA Compliance > 200 requirements: in place (cost savings) UAB administrative support Computer Hardware (Server) Will share INTERMACS server (no initial cost)

What does the current system include? WBDE Training Session What does the current system include? Phase I October 1, 2015 Mirror of data collection forms Revisit/revision of all forms Tool for data management Create Administrative System Phase II April 2016 Business rules on all forms and data fields Phase III Future Data download of a hospital’s data Phase IV Analytics: survival curves and analyses at local hospital *Phase III and Phase IV will be possible with an expansion of the PHTS mission.

PHTS Listings and Transplants 20+ years of data and form changes/additions January 1, 1993 – October 31, 2016 Listings: 8,192 Transplants: 5,951 Total Forms: 97,912

WBDE System The Dream: New Opportunities More timely data submission Better quality data More frequent QA reports Unanticipated Consequences Changing Data Entry Personnel More People Training WBDE Training in PHTS New attention from local IRB

Data Submission Deadlines Event Occurrence Months Absolute Submission Deadline 1st Quarter January February March April 30th   2nd Quarter April May June July 31st 3rd Quarter July August September October 31st 4th Quarter October November December January 31st

2015 Pediatric Transplants US Hospitals (47) 457 Reported by UNOS for all pediatric heart transplant centers 440 Reported by UNOS for PHTS Centers 96% Potential percentage of all US pediatric heart transplants if all PHTS centers report 100% of individual center transplants* 420 Reported to PHTS for the calendar year 2015 92% of US transplants *some patients may be ineligible

2015 Pediatric Transplants Non-US Hospitals (5) Canadian European Brazilian 38 Total non US transplants reported to PHTS 8% Non US center pediatric transplant

Quality Assurance Reports 2015 QA Reports will be distributed in December 2016 Includes listings and transplants through December 31, 2015 Centers with large quantities of missing data were either censored or excluded. Report included benchmarking information from all of PHTS.

Post-Transplant Outcomes in Pediatric VAD Patients: A Pedimacs-PHTS Linkage Study David Sutcliffe1, Elizabeth Pruitt,2, Ryan Cantor2, James K. Kirklin2, David Naftel2, Jodi Lantz1, Justin Godown3, John Lane4, Mark Turrentine5, Sabrina Law6, Besty Blume7, and Dan Bernstein8. 1Children’s Health Dallas, University of Texas Southwestern, Dallas, TX; 2University of Alabama at Birmingham, Birmingham, AL; 3Monroe Carrell Jr. Children’s Hospital at Vanderbilt, Nashville, TN; 4Phoenix Children’s Hospital, Phoenix, AZ; 5Riley Hospital for Children, Indianapolis, IN; 6Columbia University-Morgan Stanley Children’s Hospital of New York Presbyterian, New York, NY; 7Boston’s Children’s Hospital, Boston, MA; 8Lucile Packard Children’s Hospital at Stanford, Palo Alto, CA.

PHTS Patients Available for Linking: 173 PHTS Transpants 1993 - 2015 5408 Transplants 1993 - 9/2012 4081 Transplants 10/2012 - 2015 1327 Retransplants 64 Primary Transplants 1263 International Hospitals 103 United States Hospitals 1160 Hospital not in Pedimacs 348 Pedimacs Hospital 813 No MCSD 628 ECMO at Transplant 12 VAD at Transplant 173 Unmatched VADs 26 Matched 147 Pedimacs Transplants 9/2012 - 2015 186 Prospective Patients 177 PHTS Hospital 163 Matched VADs Temporary 11 Durable 136 Continuous 62 Pulsatile 74 Unmatched 16 Not Found in PHTS Retransplanted 5 Hospital not in PHTS 14 Retrospective Patients 9 PHTS Patients Available for Linking: 173 Pedimacs Patients Available for Linking: 163 Exact Matches: 116

WBDE Update Current Status of WBDE Successful creation of the WBDE has occurred Successful migration of old data into the new system has occurred The regulatory requirements (IRB approval and informed consent) is essentially complete The local coordinators have successfully navigated the WBDE waters Opportunity remains for semi-annual hospital reports and data reporting and analysis tools in the WBDE