Roads, Maps, and Destinations: the Journey of Left Ventricular Assist Device Implantation in Ambulatory Patients with Advanced Heart Failure.

Abstract

The benefit of left ventricular assist devices in patients dependent on inotropes or temporary mechanical support is clear. There is a large population of advanced heart failure patients who are ambulatory and not dependent on inotropes, but in whom mortality remains high. We review the limited evidence regarding the benefits and risks of LVADs in this population. The REVIVE-IT trial, which aimed to study the use of LVADs in patients who are less sick and do not meet current FDA-indications, was suspended due to lack of equipoise in the setting of a spike in pump thromboses. The ROADMAP trial was a non-randomized study that compared HMII DT LVAD to optimal medical therapy in ambulatory patients who were not on inotropes. Patients in the LVAD arm were more likely to reach the primary endpoint, being alive at 12months with an improvement in 6-min walk distance. There was a quality of life and functional capacity advantage in the LVAD arm, but at a cost of increased adverse events. The use of LVADs in ambulatory, non-inotrope dependent patients should be carefully considered, and risks and benefits should be discussed with patients before they clinically deteriorate.