Abstract 15139: Safety and Efficacy of Extracorporeal Membrane Oxygenation for Bridge-to-Heart Transplantation Among Us Children
Background: FDA-approval of emerging pediatric ventricular assist devices (VADs) may involve some comparison of first-generation VADs to extra-corporeal membrane oxygenation (ECMO) given its role as the historical treatment standard. Because ECMO has never been formally reviewed by the FDA for the indication of bridge-to-transplant, data on the utility and safety of ECMO when used specifically for bridge to heart transplant (HT) are limited.
Methods: Data from the Extra-corporeal Life Support Organization Registry (ELSO) and the Organ Procurement and Transplantation Network (OPTN) were merged to identify children with severe heart failure who were supported with ECMO while actively listed for HT between 1990 and 2009. Logistic regression was used to identify independent predictors of survival to transplant and survival to hospital discharge conditional upon transplant.
Results: Of 773 children who met the study inclusion criteria, the median age was 2.3 years (IQR 0.5 to 9.7); 45% were female, 28% had cardiomyopathy (CMP). Following a median ECMO duration of 22 days (95% CI 19, 25), 346 (45%) children were ultimately transplanted. A total of 301 (39%) died during the waiting period [including 272 (35%) who died while on ECMO]; 436 (56.2%) died prior to hospital discharge. Waiting list mortality was independently associated with congenital heart disease (CHD) (OR 1.8 95% CI, 1.2, 2.5), CPR prior to ECMO (OR 1.4, 1.1, 2.1), and severe renal dysfunction (OR 2.7 95% CI 1.5, 4.6), whereas post-transplant mortality was associated with similar factors plus ECMO duration >14 days (OR 3.3, 1.7, 6.5) and initial ECMO use as a bridge-to-recovery (OR 3.2, 1.8, 5.8). Of those successfully transplanted, 117/346 (34%) died prior to hospital discharge. Complications on ECMO included bleeding in 46%, infection in 17%, CNS event in 16%, and device malfunction in 23%.
Conclusion: ECMO is not reliable for long-term circulatory support which is often necessary for children awaiting heart transplant. More than half of all children bridged with ECMO failed to survive to hospital discharge including one-third of patients successfully transplanted. Among transplant recipients, ECMO duration of >14 days was associated with in-hospital mortality.
- Ventricular assist devices
- Extracorporeal circulation
- Congenital heart disease
- Transplantation/surgical aspects
- © 2010 by American Heart Association, Inc.