Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients Assessment of Patient Characteristics and Impact on Patient Decision-Making Joseph Rogers, MD Professor of Medicine Duke University Disclosures: None Decision-Making Challenges: The ROADMAP for Medical Patients INTERMACS 9 th Annual Meeting MCSD: Evolution, Expansion, and Evaluation May 15-16, 2015
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Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in Ambulatory Heart Failure Patients Assessment.
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Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device and Medical Management in
Ambulatory Heart Failure PatientsAssessment of Patient Characteristics and Impact on Patient Decision-Making
Joseph Rogers, MDProfessor of MedicineDuke University
Disclosures: None
Decision-Making Challenges:The ROADMAP for Medical Patients
INTERMACS 9th Annual MeetingMCSD: Evolution, Expansion, and Evaluation
Other (Drug and alcohol abuse, financial, compliance concerns, etc.) 9 (9%)
Patient Reason for Selecting OMM N (%)
Patient doesn’t like the idea of major device implantation surgery 40 (39%)
Patient doesn’t want to depend on a machine 26 (25%)
Patient doesn’t feel sick enough 25 (24%)
Patient is worried about too many complications with a LVAD 21 (20%)
Patient doesn’t think a LVAD will improve quality of life 13 (13%)
Patient Reason for selecting LVAD N (%)
Patient thinks it will improve chances to live longer 81 (84%)
Patient thinks it will improve QoL 79 (81%)
Patient thinks it will improve heart failure symptoms 72 (74%)
Patient thinks it will help them return to activities they enjoy 72 (74%)
Patient Questionnaire at Baseline
Impact of Baseline QoL Satisfaction
9
Not or slightly satisfied (n=123) Moderately to extremely satisfied (n=123)
Primary End-Point *Significantly more LVAD than OMM patients were alive
at 12 months on original therapy with increase in 6MWD by 75m
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O.R. = 2.4 [1.2-4.8]P=0.017
O.R. = 3.7 [1.1-12.2]P=0.026
O.R. = 1.7 [0.6-4.6]P=0.423
N= 85 81 57 26 26 54
Stratified by INTERMACS Profile
***17% of OMM patients crossed over to LVAD
Secondary Endpoints
• VAD Treated Patients Experienced– Better improvements in NYHA Class– Better improvements in 6 MWD– Better improvement in health-related QoL– Better improvement in depression scores
Summary and Conclusions
• ROADMAP demonstrated that patients with advanced heart failure not treated with inotropes have a better improvement in survival associated with an increase in 6MWD > 75m treated with VAD vs. OMM
• Patients selecting VAD in ROADMAP:– Reported worse symptoms – Had lower submaximal exercise performance– Had lower heath-related QoL and were dissatisfied with QoL– Had more depression– Thought VAD would improve survival, QoL and functionality