Reliability of the Thoratec HeartMate II flow measurements and alarms in the presence of reduced or non-existent flow

Abstract

Introduction: The Thoratec Corporation has over 10,000 patients registered as recipients of the HeartMate II left ventricular assist device (LVAD) worldwide. Although it has undoubtedly prolonged the lifespan of heart failure patients, the most recognized risk associated with these devices is the development of thrombus. In the presence of a small or developing clot, the HeartMate II display module and system monitor indicate that there is a decrease in pump flow, adjusts its pump power and is accompanied by audible and visual alarms when flow rates drop below a fixed threshold established by Thoratec. In contrast, when thrombus completely inhibits flow through the device, the display module and system monitor have failed in previous case studies to indicate that flow has reduced to zero and do not produce any corresponding alarms. Methods: To test the efficacy of the HeartMate II alarms, a cardiovascular simulation tank was used to reproduce the hemodynamics of a typical heart failure patient. The hemodynamics were then improved by the addition of the HeartMate II LVAD and different partial and complete occlusions were applied to the inlet and outlet of the HeartMate II pump. Conclusions: Partially occluding the inflow and/or outflow of the HeartMate II did display changes in flow and presented with alarms when flow was estimated to be below 2.5 L/min; however, complete occlusion of the inflow and/or outflow failed to produce any alarms or accurately measured changes in flow.