To ventricular assist devices or not: When is implantation of a ventricular assist device appropriate in advanced ambulatory heart failure?

Table 1 Studies analyzing the early implantation of left ventricular assist devices

Study	Objective	Significant findings
ROADMAP	Compare outcomes of HeartMate II implantation in destination therapy patients who are not dependent on inotropic support with those on optimal medical management	Early LVAD implantation associated with improved quality of life and more adverse events. Intent to treat analysis showed no survival benefit with early implantation
REVIVE-IT	Compare outcomes of HeartMate II implantation in NYHA class III patients not severe enough to qualify for transplant or permanent LVAD therapy with those on optimal medical management	Study discontinued due to difficulty recruiting from observed increase in pump thrombosis (enrolled 0/100 patients (randomized study), 0/2500 patients (screening registry)
MedaMACS	Characterize and report on patients with ambulatory advanced heart failure who have not receive an LVAD	Patients desire LVADs and LVAD shows survival benefit compared to medical management for INTERMACS 4 and 5

ROADMAP and REVIVE-IT both evaluated the impact of implanting LVADs earlier in the heart failure progression while MedaMACS created a registry of patients on optimal medical therapy without LVADs to parallel INTERMACS data, and allow for a comparison of patients with LVADs to patients on optimal medical therapy; REVIVE-IT: Registry Evaluation of Vital Information for VADs in Ambulatory Life; NYHA: New York Heart Association; MedaMACS: Medical Arm of the Interagency Registry for Mechanically Assisted Circulatory Support; LVAD: Left ventricular assist devices.