Bridging gaps in pediatric device development: The power of ACTION - a collaborative learning network

Area of Science:

• Pediatric Cardiology
• Medical Device Innovation
• Health Outcomes Research

Background:

• Pediatric ventricular assist devices (VADs) have significantly improved outcomes for children with end-stage heart failure.
• Innovation in pediatric VADs faces challenges due to small, heterogeneous patient populations, leading to financial and regulatory barriers.
• The Advanced Cardiac Therapies Improving Outcomes Network (ACTION) was created in 2017 to address these challenges.

Purpose of the Study:

• To describe the intentional design of the ACTION registry.
• To explain how this design mitigates regulatory and financial barriers to pediatric VAD innovation.
• To highlight the use of real-world evidence within a learning network to advance pediatric VAD technology.

Main Methods:

• Establishment of the ACTION learning network in 2017.
• Development of a registry with intentional design features.
• Collection and utilization of real-world evidence from pediatric VAD patients.

Main Results:

• The ACTION registry's design has successfully addressed regulatory and financial limitations.
• Real-world evidence gathered through the network facilitates pediatric VAD innovation.
• Improved outcomes for pediatric patients supported by VADs are being achieved.

Conclusions:

• The ACTION registry model effectively overcomes barriers to pediatric VAD innovation.
• Real-world evidence and a collaborative learning network are key to advancing pediatric cardiac therapies.
• This approach supports the development and implementation of improved VADs for children.