JHLT Open (Nov 2024)
Quality of life in pediatric patients on a paracorporeal ventricular assist device with a novel mobile driving system
Abstract
Background: EXCOR ventricular assist device (VAD) is the gold standard circulatory support for children with end-stage heart failure. Until recently, the only available driving unit was the stationary Ikus. This study (NCT04634708) investigates the impact of the novel mobile EXCOR Active driving unit on patients’ mobility and the quality of life (QoL) of their families. Methods: Children on EXCOR VAD support with the Ikus who were mobilizable outside the hospital room were eligible for the prospective study. Patients remained on Ikus for 7 days, then switched to Excor Active, and were observed for another 45 days. The end-points were the rates of clinically relevant device exchanges (i.e., exchanges that could raise safety concerns for the patient) and successful patient outcomes, respectively. QoL of patients’ families was recorded through 2 validated questionnaires: the Pediatric Quality of Life Inventory Family Impact Module and Depression, Anxiety and Stress Scale 21. Patients’ mobility and activity levels were monitored through diary entries. Results: A total of 24 patients were enrolled of which 23 patients completed the study. No clinically relevant device exchanges occurred and there was a successful outcome in 22/23 (95.7%) patients. Changing from the Ikus to the EXCOR Active improved QoL as seen in family impact total score (from 53.8 ± 19.8-66.5 ± 20.8, p = 0.005) and mental health (depression: moderate to mild, stress moderate to normal, both p < 0.05; anxiety: mild to normal, n.s.). Activity levels raised in both, mean time (from 100-300 min/day, p = 0.011) and distance (from 30-1,110 m/day, p = 0.002). Conclusions: The EXCOR Active driving unit is safe and performs equivalent to Ikus. This study indicates considerable improvement in patients’ mobility. In addition, data suggest that families’ QoL is positively affected by means of the novel driving unit.
