Browsing by Autor "Nader Moazami"

Filter results by typing the first few letters
Now showing 1 - 2 of 2
  • Thumbnail Image
    Item type: Item ,
    Abstract 10948: Patient-reported Quality of Life is a Predictor of Outcomes After Left Ventricular Assist Device Compared to Medical Therapy - Results From the ROADMAP Study
    (Lippincott Williams & Wilkins, 2015) Josef Stehlik; Donald Haas; Jerry D. Estep; Craig H. Selzman; Joseph G. Rogers; Carmelo A. Milano; Douglas Horstmanshof; James W. Long; Brian A. Bruckner; Nader Moazami
    Introduction: The ROADMAP study examined outcomes in subjects with non-inotrope dependent advanced heart failure (n-HF) selected for either left ventricular assist device (LVAD) or optimal medical management (OMM). At 12 months, more LVAD subjects achieved the composite endpoint of survival and ≥75m improvement in 6-minute walk distance (6MWD), while all-cause mortality was similar in the 2 groups. This suggests the focus in decision-making should be on health related quality of life (HRQoL). Aim: The aim of this study was to identify predictors of favorable outcome in n-HF patients treated with LVAD or OMM. Methods: We analyzed ROADMAP study data from 200 n-HF pts receiving LVAD or OMM. HRQoL was assessed with the EQ-5D visual analog scale (VAS) that ranged from 0 (worst) to 100 (best) health status. Results: At baseline, both LVAD and OMM group had markedly impaired exertional capacity and HRQoL (Table 1). We found that baseline VAS was a powerful predictor of the utility of LVAD therapy. Subjects with VAS<60 at baseline were more likely to achieve a positive outcome at 12 months (defined as survival with ≥75m 6MWD increase or survival with HRQoL VAS≥60) with LVAD compared to OMM (Table 1) thus favoring LVAD for these patients. No significant difference between treatments was seen for those with VAS≥60 at baseline (Table 1), supporting continued OMM. Similar results were seen when the examined outcome was survival as treated on original therapy (Figure 1). Conclusions: Patients with poor baseline QoL benefit the most from LVAD therapy compared to continued OMM. HRQoL assessed by EQ5D VAS provides valuable information that can aid in identification of suitable candidates for LVAD therapy.
  • Thumbnail Image
    Item type: Item ,
    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
    (Lippincott Williams & Wilkins, 2015) Douglas Horstmanshof; Keyur B. Shah; Joseph G. Rogers; James W. Long; Randall C. Starling; Nader Moazami; Brian A. Bruckner; Vigneshwar Kasirajan; Donald Haas; Rohinton J. Morris
    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.