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Berlin Heart EXCOR and ACTION post-approval surveillance study report
Farhan Zafar1, Jennifer Conway2, Mark S Bleiweis3
1Cincinnati Children's Hospital Medical Center, University of Cincinnati, Cincinnati, Ohio.
Summary
Outcomes improved for pediatric patients receiving the Berlin Heart EXCOR ventricular assist device (VAD), with reduced adverse events like stroke and pump exchange. This highlights advancements in mechanical circulatory support and collaborative learning in pediatric heart failure care.
Area of Science:
- Pediatric Cardiology
- Mechanical Circulatory Support
- Biomedical Engineering
Background:
- The Berlin Heart EXCOR Pediatric (EXCOR) ventricular assist device (VAD) has been used in North America for nearly two decades.
- The EXCOR received Food and Drug Administration (FDA) approval via Humanitarian Device Exemption in 2011 and Post-Market Approval (PMA) in 2017.
- Significant advancements in pediatric mechanical circulatory support, including device options and anticoagulation strategies, have occurred since the EXCOR's initial approval.
Purpose of the Study:
- To summarize outcomes of pediatric patients supported with the EXCOR VAD using data from the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) registry.
- To evaluate the effectiveness of the EXCOR VAD within the context of evolving pediatric mechanical circulatory support practices.
- To compare current EXCOR VAD patient outcomes with a historical cohort as part of a Post-Market Surveillance (PSS) study required by the FDA.
Main Methods:
- Data were collected from the ACTION registry, a collaborative of over 40 pediatric heart failure programs.
- Included were 72 North American patients with EXCOR implants from 2018-2020 (EXCOR PSS group).
- This group was compared to a historical cohort of 320 patients from a previous Berlin Heart EXCOR study (BHS group, 2007-2014).
Main Results:
- The EXCOR PSS group had younger, smaller patients, more congenital heart disease, and longer support durations compared to the BHS group.
- Primary anticoagulation in the PSS group was bivalirudin (92%).
- Success (transplant, weaned, or alive on device at 180 days) was 86% in the PSS group versus 76% in the BHS group. Stroke incidence decreased by 44%, and pump exchange by 40% in the PSS group.
Conclusions:
- The EXCOR PSS data from the ACTION registry demonstrate improved outcomes for pediatric patients using the Berlin Heart EXCOR VAD compared to historical data.
- These improvements may be attributed to evolving patient care practices and collaborative learning within pediatric heart failure programs.
- The findings underscore the continued role and evolving efficacy of the EXCOR VAD in pediatric mechanical circulatory support.
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