1. Intermacs and the Scientific Registry of Transplant Recipients (SRTR)
José A. Tallaj, MD
Division of Cardiovascular Disease
Birmingham VA Medical Center
The University of Alabama at Birmingham

2. Disclosure Information
Nothing to disclose
Slide: Disclosure Information: Educator

3. ISHLT 2014

4. Trolley Problem by Phillipa Foot

5. Study Question To VAD or to Transplant
In a similar group of patients, which therapy would lead to a better survival

6. Background
Heart Transplantation (HxTxp) and Mechanical Circulatory Support (MCS) are acceptable therapies for patients with end-stage heart disease
Both improve survival
Both improve QOL
HxTxp has long-term outcomes
60% at 10 years
MCS is a relatively young field

7. Background VAD technology is improving rapidly.
The expectation is that it will continue to improve over time.
The question becomes, which therapy leads to a better survival.

8. North American national registry for MCS devices
Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS)
North American national registry for MCS devices
Durable, approved devices
Enrollment started 2006
> 16,000 patients enrolled
>13,500 continuous flow devices

9. Scientific Registry for Transplant Recipients (SRTR)
National database of transplant statistics, collected by the Organ Procurement and Transplantation Network (OPTN), and administered by the Chronic Disease Research Group (CDRG) of the Minneapolis Medical Research Foundation (MMRF)
Supports ongoing evaluation of the scientific and clinical status of solid organ transplantation
Started in 1988
62,500 heart transplants recipients

10. SRTR Survival 2007-09 1 yr - 88.8%, 3-yr - 82.1% 5-yr - 75.9%
Patient survival estimated using unadjusted Kaplan‐Meier methods. For recipients of more than one transplant during the period, only the first is considered. Ventricular assist device (VAD) status at time of transplant. IABP, intra‐aortic balloon pump.
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yr %,
3-yr %
5-yr %
07/12-12/14 1 yr %,
3-yr %
American Journal of Transplantation pages , 11 JAN 2016 DOI: /ajt

11. Adult and Pediatric Heart Transplants Kaplan-Meier Survival (Transplants: January 1982 – June 2013)
N at risk at 30 years = 16
Survival was calculated using the Kaplan-Meier method, which incorporates information from all transplants for whom any follow-up has been provided. Since many patients are still alive and some patients have been lost to follow-up, the survival rates are estimates rather than exact rates because the time of death is not known for all patients. Therefore, 95% confidence limits are provided about the survival rate estimate; the survival rate shown is the best estimate but the true rate will most likely fall within these limits.
The median survival is the estimated time point at which 50% of all of the recipients have died. The conditional median survival is the estimated time point at which 50% of the recipients who survive to at least 1 year have died. Because the decline in survival is greatest during the first year following transplantation, the conditional survival provides a more realistic expectation of survival time for recipients who survive the early post-transplant period.
2015
JHLT. 2014 Oct; 33(10):
JHLT Oct; 34(10):

12. Adult and Pediatric Heart Transplants Kaplan-Meier Survival by Age Group (Transplants: January 1982 – June 2013)
p <
Survival was calculated using the Kaplan-Meier method, which incorporates information from all transplants for whom any follow-up has been provided. Since many patients are still alive and some patients have been lost to follow-up, the survival rates are estimates rather than exact rates because the time of death is not known for all patients. The median survival is the estimated time point at which 50% of all of the recipients have died.
The conditional median survival is the estimated time point at which 50% of the recipients who survive to at least 1 year have died. Because the decline in survival is greatest during the first year following transplantation, the conditional survival provides a more realistic expectation of survival time for recipients who survive the early post-transplant period.
Survival rates were compared using the log-rank test statistic.
2015
JHLT. 2014 Oct; 33(10):
JHLT Oct; 34(10):

13. INTERMACS

14. INTERMACS

15. INTERMACS

16. yr %,
3-yr %
5-yr %
07/12-12/14 1 yr %
3-yr %

17. Methods Merge Intermacs and SRTR database Continuous flow devices only
All, DTs or BTTs
SRTR data gathering is not as extensive or detailed

18. VAD vs Transplant
Listed
Transplant
VAD

19. “Intention” to transplant vs VAD therapy
VAD vs Transplant
Listed
Transplant
VAD
“Intention” to transplant vs VAD therapy

20. “Intention” to transplant vs VAD therapy
VAD vs Transplant
Listed
Transplant
VAD
“Intention” to transplant vs VAD therapy

21. Transplant vs VAD therapy
VAD vs Transplant
Listed
Transplant
VAD
Transplant vs VAD therapy

22. Transplant vs VAD therapy
VAD vs Transplant
Listed
Transplant
VAD
Transplant vs VAD therapy

23. Propensity Score Match
Demographics
Co-morbidities
Cr, TB
Severity of illness
Intermacs profile
N properly matched
200 enough?

24. Questions to be answered
Subgroup analysis
Which patients do better with Txp or MCS?
Co-morbidities
BiVADs
Intention of Txp vs intention LVAD
N properly matched
200 enough?

25. To VAD or to Transplant

26. To VAD or to Transplant

27. To VAD or to Transplant

28. Limitations SRTR database is not as detailed Regional preference
Patient characteristic bias
Patients as own control
Involved multiple agencies
Open conversation

29. Future Directions Ethics of randomized trial Further subgroup analysis
Pilot for further merges
Pediatric
International (ISHLT)
? CTRD-like database
Medical management (MEDAMACS)

30. HF Medical Rx
Recovery
Progression
Palliation
MCS
Transplant