1. ISHLT iPHF REGISTRY Status and Update
April 2017
Based on data as of March 15, 2017
2017

2. Goals of the Registry
To collect and analyze clinically relevant data on pediatric heart failure patients in order to better understand the natural history and response to current and future disease treatment regimes.
2017

3. Enrollment Overview First patient enrolled: April 4, 2016 16 Centers
81 patients
2017

4. Participating Institutions (N=16)
* Institutions enrolled as of March 15, 2017
2017

5. In Progress
Boston Children’s
Cincinnati
2017

6. Potential Centres (have expressed interest / been in contact)
Newcastle
Singapore
Rady Children’s (San Diego)
Arkansas
Washington
Kentucky
Utah
Delaware
Montefiore
Osaka, Japan
La Paz, Spain
Oslo, Norway
Michigan
?Others?
2017

7. Enrollment Activities
As of March 15, 2017
Number of centers: 16
Number of patients: 81
2017

8. Age Distribution at Enrollment
(Patients diagnosed during 1/1/2016 – 3/3/2017)
N=81
2017

9. Race Distribution at Enrollment
(Patients diagnosed during 1/1/2016 – 3/3/2017)
N=75
2017

10. Gender Distribution at Enrollment
(Patients diagnosed during 1/1/2016 – 3/3/2017)
N=81
z scores
2017

11. Weight Distribution at Enrollment
(Patients diagnosed during 1/1/2016 – 3/3/2017)
N=74
Z scores
2017

12. Diagnosis at Enrollment
(Patients diagnosed during 1/1/2016 – 3/3/2017)
N=81
2017

13. Medical Condition at Enrollment
(Patients diagnosed during 1/1/2016 – 3/3/2017)
N=75
2017

14. Life Support at Enrollment
(Patients diagnosed during 1/1/2016 – 3/3/2017)
N=75
2017

15. Functional Status at Enrollment
(Patients diagnosed during 1/1/2016 – 3/3/2017)
N=73
2017

16. Academic Progress at Enrollment
(Patients diagnosed during 1/1/2016 – 3/3/2017)
N=74
2017

17. Academic Activity Level at Enrollment
(Patients diagnosed during 1/1/2016 – 3/3/2017)
N=73
2017

18. Cognitive Development at Enrollment
(Patients diagnosed during 1/1/2016 – 3/3/2017)
N=72
2017

19. Motor Development at Enrollment
(Patients diagnosed during 1/1/2016 – 3/3/2017)
N=72
2017

20. LVEF at Enrollment
(Patients diagnosed during 1/1/2016 – 3/3/2017)
N=64
2017

21. LVEDD at Enrollment
(Patients diagnosed during 1/1/2016 – 3/3/2017)
N=46
2017

22. MR at Enrollment 2017 (Patients diagnosed during 1/1/2016 – 3/3/2017)

23. Qualitative RV Function at Enrollment
(Patients diagnosed during 1/1/2016 – 3/3/2017)
N=71
2017

24. Qualitative RV Size at Enrollment
(Patients diagnosed during 1/1/2016 – 3/3/2017)
N=71
2017

25. Heart Catheterization at Enrollment
(Patients diagnosed during 1/1/2016 – 3/3/2017)
N=72
2017

26. Creatinine at Enrollment
(Patients diagnosed during 1/1/2016 – 3/3/2017)
N=74
2017

27. BNP at Enrollment 2017 (Patients diagnosed during 1/1/2016 – 3/3/2017)

28. nt-pro BNP at Enrollment
(Patients diagnosed during 1/1/2016 – 3/3/2017)
N=28
2017

29. Number of Hospitalizations
(Patients diagnosed during 1/1/2016 – 3/3/2017)
N=64
2017

30. Reasons for Hospitalization
(Patients diagnosed during 1/1/2016 – 3/3/2017)
N=62
2017

31. Length of First Hospitalization
(Patients diagnosed during 1/1/2016 – 3/3/2017)
N=61
2017

32. Interventions Initiated on First Hospitalization *
(Patients diagnosed during 1/1/2016 – 3/3/2017)
N=60
* Only most common interventions are displayed; Patients may be reported with more than one intervention.
2017

33. Outcomes of First Hospitalization
(Patients diagnosed during 1/1/2016 – 3/3/2017)
N=64
2017

34. Why Participate? Benefits to Centers
Statistical summaries of hospital experience
Participate in heart failure research
Generate volume and trend data to facilitate short and long term manpower and financial planning
2017

35. Why Participate? Benefits to pediatric heart failure community
Improved outcomes
Facilitate accelerated evaluation of new therapies (drugs and devices)
Development of international standards for pediatric heart failure
2017

36. Challenges: IRB and Data Sharing Agreements
Templates online
Consents online – including Spanish consents
Some non-NA centers having challenges (e.g. Europe)
Data sharing agreement with UNOS
Draft online
2017

37. Challenges: Data Entry
Feedback: Not difficult (data elements clear; web-based data entry very user friendly)
Time
Enrollment: mins
Hospitalization form: mins
2017

38. Challenges: Data Entry
Human Resources***
MD – fastest but workload and time
Clinical APN or RN – have knowledge base but workload and time
Research APN or RN
Research coordinator – education
Seems to be easiest if incorporated into patient care workflow
2017

39. Why should we persist? Funding – ISHLT Infrastructure – The database
Collaboration – All of Us
Unique – there is no other way to get this data to address gaps in knowledge
Very Unique – merger projects with PEDIMACS/IMACS and the Transplant Registries (ISHLT, PHTS, and UNOS)
2017

40. iPHFR Patient Destinations
Recovery
Stable HF
MCS (Pedimacs, iMacs)
Listing (PHTS, UNOS)
Tx (ISHLT, PHTS, UNOS)
And the ability to understand better recovery and stability
2017

41. Steering Committee Anne Dipchand (Chair) Richard Kirk Chris Almond
Christina VanderPluym
Angela Lorts
Yuk Law
Elfi Pahl
Estela Azeka
Robert Gajarski
Scott Auerbach
Warren Zuckerman
Wida Cherikh (UNOS)
2017

42. Institutional enrollment information available at...
2017

43. Questions?
2017