Download The Roadmap for Medical Patients

Decision-Making Challenges:
The ROADMAP for Medical Patients
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
INTERMACS 9th Annual Meeting
MCSD: Evolution, Expansion, and Evaluation
May 15-16, 2015
Disclosures: None
Joseph Rogers, MD
Professor of Medicine
Duke University
ROADMAP Patient Populations
Class
IIIB
NYHA Class III
INTERMACS Profiles
Percent of current
implants in INTERMACS
7
6
1.0%
1.4%
Class IV
(Ambulatory)
5
4
3.0%
14.6%
Class IV
(On Inotropes)
3
29.9%
2
1
36.4%
14.3%
FDA Approval: Class IIIB/IV
CMS Coverage: Class IV
Currently Not Approved
Limited Adoption
Acceptance
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
Rogers JG et al: ROADMAP Trial Design: Am Heart J 2015;169:205-10
3
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
Rogers JG et al: ROADMAP Trial Design: Am Heart J 2015;169:205-10
4
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
LVAD
(n=97)
OMM
(n=103)
P
Enrollment Age (yrs) *
64 [21-82]
66 [23-82]
0.269
Male sex (%)
75 (77%)
71 (69%)
0.204
Race
White
72 (74%)
60 (58%)
Black
21 (22%)
35 (34%)
Other
4 (4%)
8 (8%)
Ischemic Etiology (%)
58 (60%)
51 (50%)
0.158
Duration of HF >1 yr
91 (94%)
95 (92%)
0.784
CRT or CRT-D
44 (45%)
43 (42%)
0.669
ICD
43 (44%)
48 (47%)
0.778
ACE Inhibitors (%)
42 (43%)
59 (57%)
0.066
Beta Blockers(%)
84 (87%)
99 (96%)
0.021
Characteristic
0.061
6
* Median [range]
Baseline Data
Parameter *
LVAD (n=97)
OMM (n=103)
47 (48%)
77 (75%)
50 (52%)
26 (25%)
Profile 4
63 (65%)
35 (34%)
Profile 5
21 (22%)
29 (28%)
Profile 6
10 (10%)
35 (34%)
Profile 7
0 (0%)
2 (2%)
VO2, RER>1.1
10.2 [8.8-11.3] (n=27)
10.9 [9.6-12.7] (n=23)
0.131
6MWD (m)
182 [122-259] (n=97)
219 [157-269 ] (n=103)
0.057
EQ5D VAS
50 [30-60] (n=93)
55 [45-75] (n=99)
<0.001
PHQ-9
10 [6-15] (n=96)
7 [3-10] (n=101)
<0.001
78 [63-89] %
84 [73-91] %
0.012
1.40 [0.93-1.81]
(n=93)
1.16 [0.57-1.94]
(n=88)
0.312
NYHA Class IIIB (%)
Class IV (%)
P
<0.001
INTERMACS
SHFM Predicted survival
HMRS Score
7
* Median [IQR]
<0.001
Reasons Provided for Choosing LVAD or OMM at Baseline
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 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%)
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.)
8
9 (9%)
Patient Questionnaire at Baseline
Impact of Baseline QoL Satisfaction
Not or slightly satisfied (n=123)
Moderately to extremely satisfied (n=123)
9
Primary End-Point *
Significantly more LVAD than OMM patients were alive
at 12 months on original therapy with increase in 6MWD by 75m
Stratified by INTERMACS Profile
O.R. = 2.4 [1.2-4.8]
P=0.017
N=
85
81
O.R. = 3.7 [1.1-12.2]
P=0.026
57
26
***17% of OMM patients crossed over to LVAD
O.R. = 1.7 [0.6-4.6]
P=0.423
26
54
10
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