Totally Implantable Artificial Heart: Still a Major Challenge

Abstract

The first mechanical heart was placed by Liotta and Cooley in 1969 in a dying patient at the Texas Heart Institute in Houston as a 2 ½-day bridge for a transplant, albeit the patient died 32 hours after transplantation.¹ Years later (1982) a totally implantable artificial heart (model Jarvik-7) was permanently implanted in a patient by DeVries et al at the University of Utah Medical Center in Salt Lake City, Utah, USA and the patient lived for 112 days.² Subsequent attempts of implantation of a total artificial heart (e.g. CardioWest/SynCardia models) have limited its use as a bridge to transplantation, like the left- or bi-ventricular assist devices (VADs).^3-7 The SynCardia model (SynCardia Systems Inc., Tuscon, AZ) has been approved for compassionate use by the Food and Drug Administration (FDA) for patients with end-stage biventricular heart failure as a bridge to transplantation since 1985 and has had FDA approval since 2004.^3-5 The SynCardia™ total artificial heart, weighing 180 g, providing a stroke volume of 70 cc, is a pneumatically driven, pulsatile system capable of flows of >9L/min. It is indicated for temporary use as a bridge to transplantation in patients with end-stage non-reversible bi-ventricular failure. Currently, the recipients of this device are hospital-bound and attached to a large pneumatic driver. The bridge to transplantation rate has been ~80% in >1100 implants. In 2010, the FDA gave conditional approval for an Investigational Device Exemption clinical study of the portable Freedom driver (SynCardia) (www.syncardia.com)... (excerpt)