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

Disclosure Information Nothing to disclose Slide: Disclosure Information: Educator

ISHLT 2014

Trolley Problem by Phillipa Foot

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

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

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.

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

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

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. © IF THIS IMAGE HAS BEEN PROVIDED BY OR IS OWNED BY A THIRD PARTY, AS INDICATED IN THE CAPTION LINE, THEN FURTHER PERMISSION MAY BE NEEDED BEFORE ANY FURTHER USE. PLEASE CONTACT WILEY'S PERMISSIONS DEPARTMENT ON PERMISSIONS@WILEY.COM OR USE THE RIGHTSLINK SERVICE BY CLICKING ON THE 'REQUEST PERMISSION' LINK ACCOMPANYING THIS ARTICLE. WILEY OR AUTHOR OWNED IMAGES MAY BE USED FOR NON-COMMERCIAL PURPOSES, SUBJECT TO PROPER CITATION OF THE ARTICLE, AUTHOR, AND PUBLISHER. 2007-09 1 yr - 88.8%, 3-yr - 82.1% 5-yr - 75.9% 07/12-12/14 1 yr - 90.6%, 3-yr - 84.5% American Journal of Transplantation pages 115-140, 11 JAN 2016 DOI: 10.1111/ajt.13670 http://onlinelibrary.wiley.com/doi/10.1111/ajt.13670/full#ajt13670-fig-0016

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): 996-1008 JHLT. 2015 Oct; 34(10): 1244-1254

Adult and Pediatric Heart Transplants Kaplan-Meier Survival by Age Group (Transplants: January 1982 – June 2013) p < 0.0001 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): 1009-1024 JHLT. 2015 Oct; 34(10): 1244-1254

INTERMACS

INTERMACS

INTERMACS

2007-09 1 yr - 88.8%, 3-yr - 82.1% 5-yr - 75.9% 07/12-12/14 1 yr - 90.6% 3-yr - 84.5%

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

VAD vs Transplant Listed Transplant VAD

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

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

Transplant vs VAD therapy VAD vs Transplant Listed Transplant VAD Transplant vs VAD therapy

Transplant vs VAD therapy VAD vs Transplant Listed Transplant VAD Transplant vs VAD therapy

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

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?

To VAD or to Transplant

To VAD or to Transplant

To VAD or to Transplant

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

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

HF Medical Rx Recovery Progression Palliation MCS Transplant