Background: Recently, a novel mobile driving unit (MDU) obtained the CE mark as driver of the
only ventricular assist device (VAD) approved for children of all ages and sizes.
The E-Motion study investigates the MDU performance, safety, outcomes, and quality
of life (QoL) of pediatric patients supported with this paracorporeal VAD in the post-market
phase. This analysis investigates whether the learning curve in MDU utilization has
an impact on patient QoL.
Method: Twenty-four patients were enrolled in the study. To be eligible for the study, patients
had to be on VAD connected to a conventional stationary driving unit and in a condition
enabling to get mobilized. Enrolled patients remained on the stationary unit for 7 ± 5
days, followed by a switch to the MDU and an additional observation period of 45 ± 7
days. All patients/caregivers completed questionnaires to evaluate QoL and stress
level by means of the Pediatric Quality of Life Inventory (PedsQL) score and the Depression
Anxiety Stress Scale (DASS-21), respectively. For this analysis, the patient cohort
was divided into group 1 (first 12 enrolled patients) and group 2 (last 12 enrolled
patients).
Results: Patients of group 1 tended to be younger (3.39 ± 5.17 years vs. 6.19 ± 6.37 years)
and were most likely to receive a left VAD (LVAD, 58.3%), whereas in the group 2 the
biventricular (BVAD) configuration was more common (54.5%). Dilated cardiomyopathy
was the most common diagnosis in both groups (66.7 and 58.3%, respectively). At the
end of study, most of the patients have experienced a successful outcome (100 and
92%, respectively), one death occurred in the group 2. QoL increased in both groups
for mobilization phase compared to stationary phase. While only a trend in QoL increase
was observed in group 1 (11.0 score points, p = 0.129), QoL significantly increased in group 2 (16.1 score points, p = 0.031). Stress level improved in both groups, but without reaching statistical
significance.
Conclusion: This analysis suggests that the experience in handling of the MDU to support pediatric
patients may impact the QoL of patients. However, this study shows a steep positive
learning curve indicating that proper MDU utilization can be achieved fast and easy.
