Study Finds Survival Advantage with TCS versus ECMO in Children on Heart Transplant Waitlist

The use of temporary circulatory support (TCS) devices in children as a bridge to heart transplant provides superior survival compared with the standard-of-care extracorporeal membrane oxygenation (ECMO), according to a study published Oct. 23 in the Journal of the American College of Cardiology.

Approximately one-half of all children supported with ECMO do not survive to hospital discharge. Previous studies of the newer generation TCS devices have been limited to case reports and single-center case series that lacked a control group or were underpowered. The aim of this study, authored by Vamsi V. Yarlagadda, MD, et al., was to determine whether bridge-to-heart transplant survival with a TCS device is superior to ECMO after adjusting for patient differences.

The study included all pediatric patients ≤21 years of age who were supported with ECMO or TCS while on the waitlist for heart transplant in the U.S. between January 2011 and December 2015, identified from Organ Procurement and Transplantation Network data. The patients were followed from the time of heart transplant listing until death or the last observation on March 30, 2016.

A total of 3,316 children ≤21 years of age were listed for heart transplant during the study period. Of these, 371 (11 percent) were supported with ECMO alone (n = 278; 75 percent) or TCS alone (n = 93; 25 percent). The number of TCS devices used in children increased from ≤3 before 2011 to 50 in 2015. ECMO use remained stable with 80 to 100 implanted per year. The CentriMag-PediMag was the most commonly used device (65 percent).

Of the 93 TCS patients, 82 were propensity score (PS) matched to an ECMO patient, for a total cohort of 164 patients. The median support duration for TCS patients was three-times longer than for ECMO patients (19 vs. 6 days; p < 0.001). CentriMag-PediMag patients had the longest median support duration compared with ECMO patients (24 vs. 6 days; p < 0.001).

Compared with the ECMO patients, the TCS patients had significantly longer waitlist survival (hazard ratio, 0.49; p = 0.003) and overall survival (hazard ratio, 0.61; p = 0.03). There was no significant difference in post-heart transplant survival between the two groups.

"Although the optimal role of TCS ventricular assist device (VAD) use in children is still being defined, continued innovation in TCS care will likely play a critical role in further reducing waitlist mortality," the authors concluded.

According to a related editorial by Jennifer Conway, MD, and Sabin J. Bozso, MD, the lack of safety outcomes is a large barrier to expanding the use of long-term VAD support in children, but "emerging analysis of registry data will provide the comparative safety profiles." "Ongoing refinement of TCS devices will continue to promote their increased utilization…ultimately leading to improved outcomes and reduced mortality," they concluded.

Clinical Topics: Cardiac Surgery, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Cardiac Surgery and Heart Failure, Heart Transplant, Mechanical Circulatory Support

Keywords: Heart-Assist Devices, Heart Transplantation, Extracorporeal Membrane Oxygenation, Propensity Score, Control Groups, Standard of Care, Waiting Lists, Tissue and Organ Procurement, Graft Survival, Registries

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