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Updated: Jun 3, 2026

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Published on: February 5, 2021
Mechanical circulatory support for infants and small children
1Instructor, Division of Congenital Heart Surgery, Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, TX, USA.
Insights
Mechanical circulatory support for pediatric heart failure lags adult options. The Berlin Heart EXCOR Pediatric is the sole long-term device for children awaiting transplants, with others years from clinical trials.
Area of Science:
- Pediatric cardiology
- Biomedical engineering
- Mechanical circulatory support
Background:
- Mechanical circulatory support (MCS) development for pediatric heart failure has historically lagged behind adult applications.
- Limited durable MCS options exist for infants and small children with acute heart failure.
- The United States saw minimal progress in pediatric MCS until the early 2000s.
Purpose of the Study:
- To review the current status of mechanical circulatory support devices for pediatric patients.
- To discuss therapy strategies for infants and small children with acute heart failure.
- To highlight the challenges and advancements in pediatric MCS.
Main Methods:
- Review of existing literature on pediatric mechanical circulatory support devices.
- Analysis of current therapeutic strategies for pediatric heart failure.
- Examination of the regulatory and clinical trial landscape for pediatric MCS.
Main Results:
- The Berlin Heart EXCOR Pediatric ventricular assist device is the only currently available long-term MCS for children awaiting cardiac transplantation.
- Access to the EXCOR Pediatric device is limited to compassionate use or investigational device exemption trials.
- Several other pediatric MCS devices are under development but require years for clinical trial testing.
Conclusions:
- Significant unmet needs exist for mechanical circulatory support in pediatric heart failure.
- The Berlin Heart EXCOR Pediatric represents a critical, albeit limited, option for critically ill children.
- Further research and development are essential to expand MCS options for infants and small children.
Abstract:
The development of mechanical circulatory support devices for infants and small children with heart failure has significantly lagged behind the development of devices for adults. In the United States, there was really very little activity focused on the development and implementation of durable mechanical assist devices for small children until the early part of this millennium. At present, the Berlin Heart EXCOR Pediatric ventricular assist device (Berlin Heart Inc., The Woodlands, TX) is currently the only device available to provide long-term support to small children awaiting cardiac transplantation; this device is only available through either compassionate use solicitation or within the confines of an ongoing investigation device exemption trial. There are several other devices being developed at this time, but it will be years before they are tested in clinical trials. In this article, we will review the current status of mechanical circulatory support devices and therapy strategies for infants and small children presenting in acute heart failure.
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