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
D. Hsu
9:35pm
New Business
M. Everitt
Registry Comparison
Feature
PHTS
Intermacs
Pedimacs
Quality Assurance Reports
Annual
Quarterly
Quarterly
Data Quality Reports
Annual
Quarterly
Quarterly
Web Based Data Entry System
FISMA Compliant
Administrative System
Manages Data
De-identified Data to Researchers
Patient Lists
Version 2
Real-Time Data Checks
Version 2
Download Excel Data
Download SAS Research Data
Coming
Analytics
2016
2016
Outcome Predictions
2016
2016
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)
WBDE Training Session
What does the current system include?
Phase I
•
•
October 1, 2015
•
•
Phase II
April 2016
• Business rules on all forms and data
fields
Phase III
Future
• Data download of a hospital’s data
Phase IV
Future
• Analytics: survival curves and
analyses at local hospital
Mirror of data collection forms
Revisit/revision of all forms
Tool for data management
Create Administrative System
*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
1st Quarter
2nd Quarter
3rd Quarter
4th Quarter
January
February
March
April
May
June
July
August
September
October
November
December
Absolute
Submission
Deadline
April 30th
July 31st
October 31st
January 31st
Forms Entered into PHTS Database
January 2014 - October 2016
500
450
Number of Forms
400
350
300
250
200
150
100
50
0
January - June
2014
July December
2014
January - June
2015
July December
2015
Month of Data Entry
Listing
Transplant
January - June July - October
2016
2016
Listings and Transplants in PHTS Database
January 2014 - October 2016
500
450
400
Frequency
350
300
250
200
150
100
50
0
January - June
2014
July December
2014
January - June
2015
July December
2015
Month of Event
Listing
Transplant
January - June July - October
2016
2016
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 Transpants
1993 - 2015
5408
Transplants
10/2012 - 2015
PHTS Patients Available for Linking: 173
1327
Pedimacs Patients Available for Linking: 163
United States
Hospitals
1160
186
Retrospective
Patients
9
Prospective
Patients
177
Hospital not
in PHTS
14
Pedimacs
Hospital
813
VAD at
Transplant
173
PHTS
Hospital
163
Matched
Matched
VADs
147
147
Unmatched
16
Retransplanted
5
Not Found in
PHTS
11
Temporary
136
Pulsatile
11
Continuous
74
62
No MCSD
12
26
International
Hospitals
103
Hospital not
in Pedimacs
348
ECMO at
Transplant
Unmatched
VADs
Durable
4081
Primary
Retransplants
Transplants
1263
64
Exact Matches: 116
Pedimacs
Transplants
9/2012 - 2015
Transplants
1993 - 9/2012
628
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