A Single-Institutional Experience with 36 Children Smaller Than 5 Kilograms Supported with the Berlin Heart Ventricular Assist Device (VAD) over 12 Years: Comparison of Patients with Biventricular versus Functionally Univentricular Circulation.

OBJECTIVES: We reviewed outcomes in all 36 consecutive children <5 kg supported with the Berlin Heart pulsatile ventricular assist device (VAD) at the University of Florida, comparing those with univentricular circulation (n  =  23) to those with biventricular circulation (n  =  13).

METHODS: The primary outcome was mortality. Kaplan-Meier methods and log-rank tests were used to assess group differences in long-term survival after VAD insertion. T -tests using estimated survival proportions and standard errors were used to compare groups at specific time points.

RESULTS: Of all 82 patients ever supported with Berlin Heart at our institution, 49 (49/82  =  59.76%) weighed <10 kg and 36 (36/82  =  43.90%) weighed <5 kg. Of these 36 patients who weighed <5 kg, 26 (26/36  =  72.22%) were successfully bridged to transplantation. Of these 36 patients who weighed <5 kg, 13 (13/36  =  36.1%) had biventricular circulation and were supported with 12 biventricular assist devices (BiVADs) and 1 left ventricular assist device (LVAD) (Age [days]: median  =  67, range  =  17-212; Weight [kilograms]: median  =  4.1, range  =  3.1-4.9), while 23 (23/36  =  63.9%) had univentricular circulation and were supported with 23 single ventricle-ventricular assist devices (sVADs) (Age [days]: median  =  25, range  =  4-215; Weight [kilograms]: median  =  3.4, range  =  2.4-4.9). Of 13 biventricular patients who weighed <5 kg, 12 (12/23  =  92.3%) were successfully bridged to cardiac transplantation. Of 23 functionally univentricular patients who weighed <5 kg, 14 (14/23  =  60.87%) were successfully bridged to cardiac transplantation. For all 36 patients who weighed <5 kg: 1-year survival estimate after VAD insertion  =  62.7% (95% confidence interval [CI]  =  48.5%-81.2%) and 5-year survival estimate after VAD insertion  =  58.5% (95% CI  =  43.8%-78.3%). One-year survival after VAD insertion: 84.6% (95% CI  =  67.1%-99.9%) in biventricular patients and 49.7% (95% CI  =  32.3%-76.4%) in univentricular patients, P   =  0.018. Three-year survival after VAD insertion: 84.6% (95% CI  =  67.1%-99.9%) in biventricular patients and 41.4% (95% CI  =  23.6%-72.5%) in univentricular patients, P   =  0.005.

CONCLUSION: Pulsatile VAD facilitates bridge to transplantation in neonates and infants weighing <5 kg; however, survival after VAD insertion in these small patients is less in those with univentricular circulation in comparison to those with biventricular circulation.