Closing the gap in paediatric ventricular assist device therapy with the Berlin Heart EXCORV® 15-ml pump

Fabrizio De Rita, Massimo Griselli, Eugen Sandica, Oliver Miera, Ann Karimova, Yves D'Udekem, Ranny Goldwasser, Katarzyna Januszewska, Antonio Amodeo, Nadine Jurrmann, Simon Ersel, Ares K. Menon

Research output: Contribution to journalArticle

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 m2were 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.

Original languageEnglish
Pages (from-to)768-771
Number of pages4
JournalInteractive Cardiovascular and Thoracic Surgery
Volume24
Issue number5
DOIs
Publication statusPublished - May 1 2017

Keywords

  • Appropriate pump size
  • Heart failure
  • Paediatrics
  • Ventricular assist device

ASJC Scopus subject areas

  • Surgery
  • Pulmonary and Respiratory Medicine
  • Cardiology and Cardiovascular Medicine

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    De Rita, F., Griselli, M., Sandica, E., Miera, O., Karimova, A., D'Udekem, Y., Goldwasser, R., Januszewska, K., Amodeo, A., Jurrmann, N., Ersel, S., & Menon, A. K. (2017). Closing the gap in paediatric ventricular assist device therapy with the Berlin Heart EXCORV® 15-ml pump. Interactive Cardiovascular and Thoracic Surgery, 24(5), 768-771. https://doi.org/10.1093/icvts/ivw437