BACKGROUND: Data for @entity1002 ( @entity1002 ) in @entity1 with noninotrope-dependent @entity712 ( @entity712 ) are limited. OBJECTIVES: The goal of this study was to evaluate @entity1605 ( @entity1605 ) @entity1002 support versus optimal medical management (OMM) in ambulatory New York Heart Association functional class IIIB/IV @entity1 meeting indications for @entity1002 destination therapy but not dependent on intravenous inotropic support. METHODS: This was a prospective, multicenter (N  = 41), observational study of 200 @entity1 (97 @entity1002 , 103 OMM). Entry criteria included  >= 1 hospitalization for @entity712 in the last 12 months and 6-min walk distance (6MWD)  <300 m. The primary composite endpoint was survival on original therapy with improvement in 6MWD  >= 75 m at 12 months. RESULTS: @entity1002 @entity1 were more severely ill, with more @entity1 classified as Interagency Registry for Mechanically Assisted Circulatory Support profile 4 (65% @entity1002 vs. 34% OMM; p  < 0.001) than 5 to 7. More @entity1002 @entity1 met the primary endpoint (39% @entity1002 vs. 21% OMM; odds ratio: 2.4 [95% confidence interval: 1.2 to 4.8]; p  = 0.012). On the basis of as-treated analysis, 12-month survival was greater for @entity1002 versus OMM (80    4% vs. 63    5%; p  = 0.022) @entity1 . Adverse events were higher in @entity1002 @entity1 , at 1.89 events/ @entity1 -year (EPPY), primarily driven by bleeding (1.22 EPPY), than with OMM, at 0.83 EPPY, primarily driven by worsening @entity712 (0.68 EPPY). Most @entity1 (80% @entity1002 vs. 62% OMM; p  < 0.001) required hospitalizations. Health-related quality of life (HRQol) and @entity308 improved from baseline more significantly with @entity1002 than with OMM (   visual analog scale: 29    25 vs. 10    22 [p  < 0.001];    @entity1 Health Questionnaire-9: -5    7 vs. -1    5 [p  < 0.001]). CONCLUSIONS: Survival with improved functional status was better with @entity1605 @entity1002 compared with OMM. Despite experiencing more frequent adverse events, @entity1002 @entity1 improved more in HRQol and @entity308 . The results support @entity1605 use in functionally limited, noninotrope-dependent @entity712 @entity1 with poor HRQoL. (Risk Assessment and Comparative Effectiveness of @entity1002 [ @entity1002 ] and Medical Management [ROADMAP]; NCT01452802).

Risk Assessment and Comparative Effectiveness of Left Ventricular Assist  Device and Medical Management in  Ambulatory XXXX @entity1 : Results From the ROADMAP Study.

@entity1 :: ('9606', 'Species') :: ['patients', 'patient', 'Patient'] @entity308 :: ('MESH:D003866', 'Disease') :: ['depression'] @entity712 :: ('MESH:D006333', 'Disease') :: ['HF', 'heart failure'] @entity1605 :: ('OMIM:217000', 'Disease') :: ['HeartMate II', 'HMII'] @entity1002 :: ('MESH:D018487', 'Disease') :: ['LVAD', 'LVADs', 'left ventricular assist devices', 'Left Ventricular Assist Device']
@entity712 :: (MESH:D006333,Disease) :: ['Heart Failure']
