Abstract 13090: Beneficial Effects of Left Ventricular Assist Device Compared to Medical Therapy in Ambulatory Non-inotropic Dependent Heart Failure Patients in INTERMACS Profiles 4 vs 5-7: Results From the ROADMAP Study

Abstract

Introduction: The role of left ventricular assist devices (LVAD) in advanced heart failure (HF) patients (pts) not dependent on intravenous inotropes is unclear. We hypothesize that the benefits of LVAD vs optimal medical management (OMM) are more pronounced in INTERMACS profile 4 (IM4) than profiles 5-7 (IM5-7). Methods: ROADMAP is a prospective, 41-center, non-randomized study of 200 pts. The objective was to evaluate the effectiveness and relative risks of HeartMate II LVAD support vs OMM in ambulatory NYHA Class IIIB/IV pts who met FDA indications for LVAD destination therapy but were non-inotrope dependent. The primary composite endpoint was survival with improvement in 6MWD ≥ 75m at 1 yr. Results: There were more LVAD pts in IM4 than IM5-7 (Table). Among IM4 pts, LVAD was 4.6X more likely than OMM to meet the primary endpoint, and 1 yr event-free survival as treated on original therapy was significantly greater for LVAD pts (Figure). The most frequent adverse event (AE) was bleeding for LVAD pts and worsening HF for OMM. For IM4 and IM5-7, LVAD pts had a higher composite of AEs compared to OMM, but freedom from rehospitalizations was similar for IM4. In OMM pts, 33% of IM4 and 15% of IM5-7 received delayed LVADs within 1 yr. Health related quality of life (HRQoL), severity of depression (PHQ-9), and NYHA class improved more at 1 yr with LVADs than OMM. Conclusions: Survival with improved functional status was better with LVADs compared to OMM in IM4 pts. HRQoL and depression improved more in all IM profiles with LVADs in spite of AEs being more frequent with LVADs. Results support the use of the HMII LVAD in functionally limited non-inotrope dependent HF patients, particularly those in IM4 profile.