First Human Implantation of A Miniaturized Axial Flow Ventricular Assist Device in a Child with End-Stage Heart Failure

Small children with end-stage heart failure who require left ventricular assist device (LVAD) support to heart transplant have limited device options, leading to high morbidity and mortality and are confined to the hospital until transplant. 1 Almond CS Morales DL Blackstone EH et al. Berlin Heart EXCOR pediatric ventricular assist device for bridge to heart transplantation in US children. Circulation. 2013; 127: 1702-1711 Crossref PubMed Scopus (356) Google Scholar ,2 Yarlagadda VV Maeda K Zhang Y et al. Temporary circulatory support in U.S. Children awaiting heart transplantation. J Am Coll Cardiol. 2017; 70: 2250-2260 Crossref PubMed Scopus (32) Google Scholar The only Food and Drug Administration (FDA)-approved durable LVAD for children is a paracorporeal pulsatile device that carries a high stroke risk and lacks portability, precluding hospital discharge. 1 Almond CS Morales DL Blackstone EH et al. Berlin Heart EXCOR pediatric ventricular assist device for bridge to heart transplantation in US children. Circulation. 2013; 127: 1702-1711 Crossref PubMed Scopus (356) Google Scholar Temporary paracorporeal continuous flow devices have also been used off-label for bridge-to-transplant but carry higher mortality, require lengthy paracorporeal cannulas prone to circuit thrombus, and typically require children to remain in intensive care. 2 Yarlagadda VV Maeda K Zhang Y et al. Temporary circulatory support in U.S. Children awaiting heart transplantation. J Am Coll Cardiol. 2017; 70: 2250-2260 Crossref PubMed Scopus (32) Google Scholar ,3 Baldwin JT Adachi I Teal J et al. Closing in on the PumpKIN Trial of the Jarvik 2015 ventricular assist device. Semin Thorac Cardiovasc Surg Pediatr Card Surg Annu. 2017; 20: 9-15 Abstract Full Text Full Text PDF PubMed Scopus (57) Google Scholar Recently, a novel, durable, fully implantable, miniaturized axial flow pump similar to more contemporary adult LVADs has been developed, but it has never been used in a human. We present the case of a 4-year-old girl with dilated cardiomyopathy who underwent the world's first pump placement in Rome, Italy. After 1 year of support, we review the lessons learned from the child's case and discuss the stiff headwinds that persist in preventing United States device companies from developing urgently needed medical devices for children.