1. 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

2. 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

3. 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

4. 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)

5. 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.

6. 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

7. 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

8. 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

11. 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

12. 2015 Pediatric Transplants
Non-US Hospitals (5)
Canadian
European
Brazilian 38
Total non US transplants reported to PHTS 8%
Non US center pediatric transplant

13. 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.

14. 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.

15. PHTS Patients Available for Linking: 173
PHTS Transpants
5408
Transplants /2012
4081
Transplants
10/
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/
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

16. 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