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Closing the gap in paediatric ventricular assist device therapy with the Berlin Heart EXCOR® 15-ml pump
Fabrizio De Rita1, Massimo Griselli1, Eugen Sandica2
1Department of Paediatric Heart Surgery, Freeman Hospital, Newcastle upon Tyne, UK.
Insights
The new 15-ml Berlin Heart EXCOR® blood pump effectively supports pediatric patients with end-stage heart failure. This device fills a critical size gap, showing 100% survival in early trials.
Area of Science:
- Pediatric Cardiology
- Mechanical Circulatory Support
- Biomedical Engineering
Background:
- The Berlin Heart EXCOR® (EXCOR) is a widely used ventricular assist device for pediatric end-stage heart failure.
- A size gap existed between the 10 ml and 25 ml EXCOR pumps, limiting options for patients with body surface area (BSA) of 0.33–0.5 m².
Purpose of the Study:
- To evaluate the clinical experience and safety of the new EXCOR 15-ml blood pump.
- To assess the device's suitability for pediatric patients within a specific BSA range.
Main Methods:
- Early product surveillance (EPS) of 20 pediatric patients (mean age 1.6 years, mean BSA 0.45 m²) approved by CE and FDA.
- Prospective data collection from high-volume pediatric transplant centers for 60 days post-implantation.
Main Results:
- 100% survival rate at the end of the 60-day EPS period.
- Mean support time was 43 days; 7 patients received heart transplants, 2 were weaned, and 11 remained on support.
- Adverse events included cannula exit site infections (3 patients) and minor thromboembolic strokes with full recovery (2 patients).
Conclusions:
- The EXCOR 15-ml blood pump provides optimal ventricular assist device support for children with BSA between 0.33 and 0.5 m².
- The device effectively addresses a critical need in pediatric mechanical circulatory support.
Objectives:
The Berlin Heart EXCOR ® (EXCOR) paediatric ventricular assist device is used worldwide for mechanical support of infants and small children with end-stage heart failure. A clinically important gap between the smallest EXCOR blood pump (10 ml) and the next larger size (25 ml) limited the choice of pump size in patients with a body surface area (BSA) between 0.33 and 0.5 m 2 . We present the first clinical experience from the early product surveillance (EPS) of the new EXCOR 15-ml blood pump.
Methods:
After CE and U.S. Food and Drug Administration approval in January 2013, 20 patients with a mean age of 1.6 years (range 0.5-3.5 years) and a mean BSA of 0.45 m 2 (range 0.33-0.59 m 2 ) were enrolled in the EPS. The main diagnosis was idiopathic cardiomyopathy in 13 patients; the majority ( n = 16) of children were in INTERMACS level 1 or 2. Data from high-volume paediatric transplant centres were collected prospectively for a defined follow-up period of 60 days after device implantation.
Results:
Mean time on the EXCOR 15-ml blood pump was 43 days; the survival rate was 100% at the end of the EPS period. Seven patients underwent a heart transplant from the device; 2 children were weaned; and 11 patients remained on support. Infection of cannula exit sites occurred in 3 patients. Two patients had minor thromboembolic strokes but made a complete neurological recovery.
Conclusions:
The new EXCOR 15-ml blood pump demonstrated optimal ventricular assist device support of children with a BSA of 0.33-0.5 m 2 .
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