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.
Patients with Fontan failure are high-risk candidates for heart transplantation and other advanced therapies. Understanding the outcomes following initial heart failure consultation can help define appropriate timing of referral for advanced heart failure care.
Outcomes after initial heart failure consultation in Fontan patients Read More »
Ricky was diagnosed with Duchenne Muscular Dystrophy (DMD) within the first year of his life. With the unyielding support of his mother, Rosie, he has defied the odds of a complex disease. From diagnosis to treatment, and now recovery, Ricky goes everywhere, experiencing life to the fullest.
Care Across State Lines: Ricky’s Journey to Life-Saving Surgery Read More »
Although waitlist mortality is unacceptably high, nearly half of donor heart offers are rejected by pediatric heart transplant centers. ACTION and PHTS convened a multi-institutional donor decision discussion forum (DDDF) aimed at assessing donor acceptance practices and reducing practice variation.
Reducing donor acceptance practice variation – Learnings from a discussion forum Read More »
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