The use of implantable left ventricular assist devices (LVADs) has been increasing to serve the growing population of patients with end-stage congestive heart failure. The currently available implantable LVADs used as a bridge to transplant have produced improvements in multiorgan function. Patients implanted with a portable, electrically powered device can become outpatients and enjoy an acceptable quality of life.1–3 Recently, the Food and Drug Administration (FDA) granted permission for the permanent use of an implantable LVAD in patients who are not candidates for cardiac transplantation. However, up to 40% of LVAD patients have significant right ventricular (RV) failure that may limit the success of the LVAD therapy.4 The RV failure leads to two problems: decreased RV output, thus low LVAD flow, and high central venous pressures that result in passive congestion of the liver, kidneys, and abdominal organs. Both factors contribute to multiorgan failure, the leading cause of death after LVAD implant. Such patients commonly require prolonged inotropic support or support with a right ventricular assist device (RVAD). Clinically available RVADs, such as the Bio-Pump® (Medtronic, Inc., Minneapolis, MN), BVS 5000 (ABIOMED, Inc., Danvers, MA), Thoratec® VAD (Thoratec Corp., Berkeley, CA), and CentriMag® (Levitronix GmbH, Zurich, Switzerland) are extracorporeal devices and have several limitations, such as need for anticoagulation, need for a hospital stay, and a less than ideal quality of life.
The purpose of this new program, funded by a National Heart, Lung, and Blood Institute (NHLBI) Bioengineering Research Partnerships (BRP) grant, is to design, develop, and clinically evaluate an implantable RVAD that can be used as a component of an implantable biventricular assist device for patients with severe biventricular heart failure. This article describes the initial phase of this program, including the pump design and in vitro test results.