Novel system for ventricular assist device support safe in children with heart failure

A novel active driving system for paediatric ventricular assist devices exhibits safety and reliability in children with heart failure, with no major malfunctions, according to a study.

Forty participants (mean age 38.2 months, 55 percent with congenital heart disease) were enrolled in this study under a US Food and Drug Administration-approved investigational device exemption, followed by 118 additional patients under a continued access protocol.

The incidence of major device malfunction, adverse events, and successful outcomes, defined as survival to transplantation, recovery, or continued support at 90 days postimplantation, served as the primary endpoints. Descriptive statistics and competing risk models were used to assess these outcomes.

No episodes of major device malfunction occurred among the 40 investigational device exemption participants. Of these, 65 percent remained on support, 17.5 percent underwent transplantation, 15.0 percent were converted to another support modality, and one was explanted for recovery at 90 days.

Ninety-day mortality rate was 0 percent, and stroke incidence was 12.5 percent.

Similarly, no major device malfunctions occurred in 118 continued access protocol patients. At the time of data abstraction, 44 (37 percent) had undergone transplantation, 37 (31 percent) remained alive on device, seven (6 percent) had the device explanted for recovery, 27 (23 percent) had been converted to another support modality, and three had withdrawal of support.

Ninety-day survival was 98.1 percent.

“This trial also validates the feasibility of leveraging a clinical registry infrastructure for class III device evaluation, offering a scalable and cost-efficient model for device approvals,” the authors said.

“Paediatric patients with heart failure increasingly rely on ventricular assist devices as a bridge to transplantation,” they noted.