Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients

• DOI: 10.1016/j.jchf.2017.02.016
• Publication Date: 2017-04-05T23:33:56Z
• Authors: Randall C. Starling; Jerry D. Estep; Douglas A. Horstm...; Carmelo A. Milano; Josef Stehlik; Keyur B. Shah; Brian A. Bruckner; Sangjin Lee; James W. Long; Craig H. Selzman; Vigneshwar Kasirajan; Donald C. Haas; Andrew J. Boyle; Joyce Chuang; David J. Farrar; Joseph G. Rogers
• Keywords: Clinical endpoint

The authors sought to provide the pre-specified primary endpoint of ROADMAP (Risk Assessment and Comparative Effectiveness Left Ventricular Assist Device Medical Management in Ambulatory Heart Failure Patients) trial at 2 years.The was a prospective nonrandomized observational study 200 patients (97 with left ventricular assist device [LVAD], 103 on optimal medical management [OMM]) that showed survival improved functional status 1 year better LVADs compared OMM patient population ambulatory New York Association class IIIb/IV patients.The composite original therapy improvement 6-min walk distance ≥75 m.Patients receiving LVAD versus had lower baseline health-related quality life, reduced Seattle Model 1-year (78% vs. 84%; p = 0.012), were predominantly INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) profile 4 (65% 34%; < 0.001) profiles 5 7. More met years: 30% 12% (odds ratio: 3.2 [95% confidence interval: 1.3 7.7]; 0.012). Survival as treated years greater (70 ± 5% 41 5%; 0.001), but there no difference intent-to-treat 63 0.307). In arm, 23 (22%) received delayed (18 within 12 months; from 24 months). adverse events declined after bleeding (primarily gastrointestinal) arrhythmias.Survival superior years. Reduction key beyond observed group. provides risk-benefit information guide patient- physician-shared decision making elective treatment heart failure. Patients [ROADMAP]; NCT01452802).