In this multicenter retrospective study of 150 pediatric patients supported with the Impella device, 89.3% achieved positive clinical outcomes despite a 28% adverse event rate. Findings suggest a potential role for Impella in managing refractory advanced heart failure in children, particularly those with cardiomyopathy, transplant graft dysfunction, or congenital heart disease.
In a prospective study of 265 males with Duchenne Muscular Dystrophy, nearly 30% of those with moderate or severe heart dysfunction were not receiving full consensus-directed cardiac therapy, and most did not reach target medication doses—highlighting the need to optimize treatment strategies as cardiac disease becomes a leading cause of death in DMD.
Cardiac Medication Use in ACTION for Duchenne Muscular Dystrophy Cardiomyopathy Read More »
Through the collection and use of real-world data, the field has gained greater understanding of best practices in care of these patients, as well as improved access to devices with pediatric labeling of devices previously approved only for adults. Recent and current work across the network’s major focus areas (VAD, heart failure, muscular dystrophy, and Fontan) are highlighted.
Innovation in pediatric medical devices is limited by financial and regulatory barriers due to the small and heterogenous target population. Intentional design of the ACTION registry has mitigated regulatory and financial barriers to pediatric VAD innovation through the use of real-world evidence gathered through a learning network.
CHD patients are more likely in extremis at VAD implantation and experience higher rates of adverse events and worse survival compared to those with non-CHD. Timely referral for patients with CHD experiencing worsening heart failure and a proactive approach to VAD implantation has the potential to improve outcomes for this vulnerable cohort.
The ACTION VADs score for mortality can be calculated easily and offers risk stratification and prognostic information for pediatric VAD candidates. This is the first validated risk assessment tool for pediatric mechanical circulatory support.
ACTION and the Academic Research Consortium (ARC) aimed to harmonize definitions of pediatric and CHD AEs for use in clinical trials, registries, and regulatory evaluation.
ACTION and the Academic Research Consortium (ARC) aimed to harmonize definitions of pediatric and CHD AEs for use in clinical trials, registries, and regulatory evaluation.
Placement of a ventricular assist device (VAD) improves outcomes in children with advanced heart failure, but adverse events remain important consequences. Preoperative mechanical ventilation (MV) increases mortality, but it is unknown what impact prolonged postoperative MV has.
The HeartWare ventricular assist device (HVAD) was discontinued in July 2021. The study aims to describe the impact the discontinuation the HVAD had on pediatric ventricular assist device (VAD) utilization and outcomes.
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