Closing the gap in paediatric ventricular assist device therapy with the Berlin Heart EXCOR® 15-ml pump†
Open Access
- 23 January 2017
- journal article
- research article
- Published by Oxford University Press (OUP) in Interactive CardioVascular and Thoracic Surgery
- Vol. 24 (5), 768-771
- https://doi.org/10.1093/icvts/ivw437
Abstract
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 m2. 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 m2 (range 0.33–0.59 m2) 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 m2.Keywords
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