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
May 15-16, 2015
ROADMAP Patient Populations
11 11 22 22 33 33 44 44 55 55 66 66 77 77INTERMACS
Profiles
CMS Coverage: Class IVCMS Coverage: Class IVCMS Coverage: Class IVCMS Coverage: Class IV
FDA Approval: Class IIIB/IVFDA Approval: Class IIIB/IVFDA Approval: Class IIIB/IVFDA Approval: Class IIIB/IV
Currently Not Approved Limited Adoption Acceptance
NYHA Class IIINYHA Class III Class Class IIIBIIIB
Class IV Class IV (Ambulatory(Ambulatory
))
Class IVClass IV(On Inotropes)(On Inotropes)
1.0% 1.4% 3.0% 14.6% 29.9% 36.4% 14.3%Percent of current implants in INTERMACS
Objectives and Study Design
• Primary Objectives
– Evaluate and compare the effectiveness of HM II LVAD support vs. optimal medical management (OMM) in
– ambulatory NYHA Class IIIB/IV patients
– not dependent on intravenous inotropic support (INTERMACS ≥ 4), and
– meet the FDA approved indications for HM II LVAD destination therapy
• Trial Design
– Prospective, multi-center, non-randomized, controlled, observational study
– Permits characterization of real-world advanced HF treatments strategies in varied health care delivery systems
– Includes collaborating cardiologists not directly involved in LVAD care
– Includes patients who do not desire LVAD treatment
– LVAD indication is already FDA approved – additional data needed to improve patient selection
3Rogers JG et al: ROADMAP Trial Design: Am Heart J 2015;169:205-10
Key Inclusion and Exclusion Criteria
Inclusion Criteria
•NYHA Class IIIB or IV ; Age 18 to 85
•Left ventricular ejection fraction (LVEF) ≤ 25%
•Not listed (or planned) for heart transplantation
•On optimal medical management (OMM)
•6MWT < 300 meters
•At least 1 hospitalization for HF in last 12 months, or 2 unscheduled ED or infusion clinic visits for HF in last 12 months
Exclusion Criteria
•Any inotrope use within 30 days
•Inability to perform 6MWT
•Any ongoing MCS (including IABP & temporary devices) at enrollment
•CRT or coronary revascularization within 3 months
4Rogers JG et al: ROADMAP Trial Design: Am Heart J 2015;169:205-10
Endpoints
• Primary Endpoint
– Composite of survival with improvement in 6-MWT distance from baseline of ≥75 meters at 12 months
• Secondary Endpoints– Actuarial survival
– Health-related Quality of Life (HRQoL) using the EQ-5D-5L Visual Analog Scale (VAS)
– Depression using Patient Health Questionnaire-9 (PHQ-9)
– Questionnaire on patient decisions related to LVAD therapy versus OMM
– Functional status using 6-MWT distance and NYHA Classification
– Adverse events, rehospitalizations
5
Baseline Data
* Median [range]6
Baseline Data
* Median [IQR]7
Reasons Provided for Choosing LVAD or OMM at Baseline
8
Physician Reason for selecting OMM N (%)
Physician believes patient isn’t good surgical candidate 14 (14%)
Physician believes patient isn’t sick enough 11 (11%)
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
10
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