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Research Topics in INTERMACS. What have we learned? What is next? Panel B: Functional Capacity, Quality of Life and Outcomes H. Functional Capacity I.Neurocognitive Assessment J.Quality of Life K.Terminal Events and Risk Factors L.Discussion. - PowerPoint PPT Presentation
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What have we learned? What is next?
Panel B: Functional Capacity, Quality of Life and Outcomes
H. Functional Capacity I. Neurocognitive Assessment J. Quality of Life K. Terminal Events and Risk Factors L. Discussion
Research Topics in INTERMACS
INTERMACS Annual Meeting
March 2012
Functional Capacity
JoAnn Lindenfeld
So far we have learned little about functional capacity
Research Topics in INTERMACS
INTERMACS Annual Meeting
March 2012
June 2006 – Sept 2008: Adult Prospective Implants
Pt Seen in 6 Minute Walk VO2 Max R at PeakFollow-up Hospital/Clinic n % n % n
%Pre-Implant 957 30 3.1% 58 6.1% 28 2.9%
3 Month 426 79 18.5% 14 3.3% 12 2.8%
6 Month 202 38 18.8% 10 5.0% 8 4.0%
12 Month 71 16 22.5% 1 1.4% 0
18 Month 16 3 18.8% 0 - 0 -
24 Month 3 1 33.3% 0 - 0 -
Total 1675 167 10.0% 83 5.0% 48 2.9%
INTERMACS Annual Meeting
March 2012
Is Frailty Predictive of Hospital Complications, Duration and
Success of Rehabilitation, and Ultimate Quality of Life?
INTERMACS Annual Meeting
March 2012
LVAD-Responsive Frailty
Systolic and diastolic dysfunction
↑PCWP and CVP↓Cardiac output
InflammationAnorexiaHypoxia
Polypharmacy
FrailtyIncreased Vulnerability to Stress
AGINGCOPD / lung disease
CancerDiabetes
OsteoporosisPeripheral vascular disease
CirrhosisNeurologic diseaseSarcopenia
MalnutritionCognitive deficits
Injurious falls
LVAD-Independent Frailty
Post-OperativeComplications
Prolonged LOSNeed for ICU care
ReducedSurvival
ImpairedHealth Status
DisabilityLoss of ADLs
Institutionalization Flint et alCirc: Heart Failure
In PressINTERMACS Annual M
eeting
March 2012
Pre-LVAD Frailty
Post-LVAD Frailty
LVAD-Responsive Frailty LVAD-Independent Frailty
Patient A Patient CPatient B
Unfavorable OutcomeHigh risk for premature death and complications with failure to improve
functional status
Intermediate OutcomeModerate risk for premature death and complications with
some persistent functional limitation
Favorable OutcomeLower risk for premature death or complications, with marked
improvement in functional status
Flint et alCirc: Heart Failure
In Press INTERMACS Annual Meeting
March 2012
Functional Capacity• Can we improve collection of functional capacity data?
• How much does functional capacity improve in LVAD recipients?
• What limits improvements in functional capacity?
• Can we measure gait speed in a high percentage of patients?
• Does gait speed add to the ability to predict mortality?
• Does gait speed add to the ability to predict post-operative complications and length of stay?
• Can we measure frailty using gait speed alone or combined with other parameters (weight loss, albumin, anemia, etc) in the database?
• Can we predict reversible frailty?
Research Topics in INTERMACS
INTERMACS Annual Meeting
March 2012
Functional Capacity
• Is gait speed predictive in those < 60 years?
• Do any of these measures of functional capacity predict QoL?
• What are the predictors of return to good functional capacity?
• What are the best measures of frailty in end-stage heart failure?
• How do we determine if frailty is reversible?
Research Topics in INTERMACS
INTERMACS Annual Meeting
March 2012
Neurocognitive Assessment
K Grady
Research Topics in INTERMACS
INTERMACS Annual Meeting
March 2012
What have we learned? • There are challenges to data collection for assessing neurocognitive function via the Trail Making Part B
• e.g., patient and coordinator burden, as it is directly administered to the patient by an examiner
• Data collection for the Trail Making Part B has been poor • There are no INTERMACS abstracts/publications to date
What is next?• Consider adding an expert (i.e., champion) in neurocognitive assessment to the INTERMACS QOL Committee and examine next steps to enhance data collection.
Research Topics in INTERMACS
INTERMACS Annual Meeting
March 2012
Neurocognitive Assessment
The biggest challenges with neurocognitive assessment in INTERMACS are:
• Collecting the Data• Making neurocognitive assessment a part of
MCSD standard of care
Research Topics in INTERMACS
INTERMACS Annual Meeting
March 2012
Neurocognitive Assessment
What are the Next Steps?
• Improving Patient Outcomes• Device Evaluation and Development
Research Topics in INTERMACS
INTERMACS Annual Meeting
March 2012
Quality of Life
K Grady
Research Topics in INTERMACS
INTERMACS Annual Meeting
March 2012
MobilityI have no problems in walking about I have some problems in walking about I am confined to bed Self-CareI have no problems with self-care I have some problems washing or dressing myself I am unable to wash or dress myself Usual Activities (e.g. work, study, housework, family orleisure activities)I have no problems with performing my usual activities I have some problems with performing my usual activities I am unable to perform my usual activities Pain/DiscomfortI have no pain or discomfort I have moderate pain or discomfort I have extreme pain or discomfort Anxiety/DepressionI am not anxious or depressed I am moderately anxious or depressed I am extremely anxious or depressed
EQ-5DHealth Questionnaire
English version for the US
QOL Instrument
INTERMACS Annual Meeting
March 2012
0
10
20
30
40
50
60
70
80
90
100
EQ-5
D V
AS
(N=39)
Pre and Post Implant EQ-5D (primary implant, prospective, adult)
Visual Analogue Scale (VAS) Across Time (mean ± SD)
Pre-Implant 3 month 6 month 12 month
(N=312)
(N=183) (N=96)
P (pre vs 3 mo) <0.001
Months Post Implant
Best
Worst
N=878 adult MCS patients, primary implant (pulsatile and continuous flow [LVAD, Bi-VAD, TAH]: 6/06-9/08); Profile 1 = 36%, Profile 2 = 38%
INTERMACS Annual Meeting
March 2012
CONCLUSIONS• Quality of life was poor before MCS implant and improved
significantly from before to after MCS implant.
• The frequency of problems in the areas of mobility, self-care, usual activities, and anxiety / depression decreased from before to after MCSD implantation.
• The frequency of pain / discomfort was similar before and after MCSD implantation.
• “Some problems” were reported more frequently than “extreme problems” in all QOL domains after MCSD implant.
• Differences in QOL before and after MCSD implantation were identified by gender and age.
INTERMACS Annual Meeting
March 2012
PURPOSE
• To examine differences in HRQOL scores, among INTERMACS profiles, both before and
at 3, 6, and 12 months after implant
• To examine patterns of HRQOL scores from before MCS implant through 1 year after implant, by INTERMACS patient profiles
Definition: Health-related Quality of Life
“The functional effect of an illness and its consequent therapy upon a patient as perceived by the patient.”
HRQOL Domains: mobility, self-care, usual activities, anxiety / depression, pain / discomfort, & perception of overall health
statusSchipper H, in Spilker B (ed) Quality of Life Assessment in Clinical Trials (1990)
INTERMACS Annual Meeting
March 2012
Primary continuous flow LVAD, n=1559
Patient Profile Levels (Pre-Implant) Status at 1 year 1 2 3 4 5-7 Total Post implant (n= 262) (n=695) (n=330) (n=175) (n=97) (n=1559)
Death 21% 16% 9% 14% 12% 15%
Transplant 36% 32% 37% 33% 29% 34%
Recovery 2% 1% 0% 0% 1% 1%
Alive (on device)* 41% 51% 54% 53% 58% 50%
Total 100% 100% 100% 100% 100% 100%
* Available for quality of life assessment at 1 year post implant
Implants: June 2006 – March 2010, Follow-up: March 2011
INTERMACS Annual Meeting
March 2012
0.00.10.20.30.40.50.60.70.80.91.0
0 3 6 9 12 15 18 21 24
June 2006 – March 2011: HRQOL by Patient Profiles(All patients with opportunity for 1 year follow-up (n=1559)
Months Post Implant
Prop
ortio
n of
Pat
ient
s
Pre-implant
Alive (device in place) 100%
Txpl 0%
Dead 0%Rec 0%
Alive (device in place) 83%
Alive (device in place) 69%
Alive (device in place) 50%
Txpl 8%Dead 9%
Rec 0%
Txpl 19%
Dead 11%
Rec 1%
Txpl 34%
Dead 15%Rec 1%
INTERMACS Annual Meeting
March 2012
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100
Level 1: Level 2: Level 3: Level 4: Levels 5-7
Pre-Implant3 months post implant1 year post implant
EQ-5D: Visual Analog Scale
INTERMACS Patient Profile Levels
BestHealth
WorstHealth
Mea
n V
AS
Primary Continuous Flow LVADs, n=2807
INTERMACS Annual Meeting
March 2012
0.0%10.0%20.0%30.0%40.0%50.0%60.0%70.0%80.0%90.0%
100.0%
Level 1: Level 2: Level 3: Level 4: Levels 5-7
Pre-Implant3 months post implant1 year post implant
EQ-5D: Mobility, Any Problems%
Pat
ient
s w
ith A
ny M
obili
ty P
robl
ems
INTERMACS Patient Profile Levels
Primary Continuous Flow LVADs, n=2807
INTERMACS Annual Meeting
March 2012
0.0%10.0%20.0%30.0%40.0%50.0%60.0%70.0%80.0%90.0%
100.0%
Level 1: Level 2: Level 3: Level 4: Levels 5-7
Pre-Implant3 months post implant1 year post implant
EQ-5D: Self Care, Any Problems%
Pat
ient
s w
ith A
ny S
elf C
are
Pro
blem
s
INTERMACS Patient Profile Levels
Primary Continuous Flow LVADs, n=2807
INTERMACS Annual Meeting
March 2012
Predictors of better QOL at 6 months after continuous flow MCS
FACTOR Parameter estimate
SE Partial R-square
Model R-square
Better NYHA at 6 months after implant
-3.2629 0.9161 0.017 0.017
No HX of COPD
-6.5129 2.0949 0.008 0.026
Worse pre implant NYHA
3.9715 1.5153 0.009 0.035
Older age 0.0020 0.0005 0.008 0.042 No HX of CABG
-4.0862 1.8274 0.006 0.048
Being likely to be listed for HT 6 mos. after implant
3.4798 1.7100 0.005 0.054
Not being rehospitalized
-2.8237 1.3954 0.005 0.059
Total R-square = 6%, F=6.97, p<0.0001
•Since the mean VAS score improved dramatically from pre-implant to 6 months post implant (42 vs 74, p< 0.0001), the most important factor for increased overall health status was MCS implant.
INTERMACS Annual Meeting
March 2012
Quality of Life
What are the Next Steps?
• Improving Patient Outcomes• Device Evaluation and Development
Research Topics in INTERMACS
INTERMACS Annual Meeting
March 2012
What is next?• Identify preoperative psychosocial stress factors (e.g., poor QOL, social isolation, education) as predictors of outcomes in women and men after primary continuous flow LVAD implant.• Longitudinal change in HRQOL (EQ-5D re 5 dimensions + VAS and KCCQ) from before to 12, 24, and 36 months after MCS
- Overall - By demographic characteristics (i.e., age, gender) - By pre implant INTERMACS profile - By implant strategy (i.e., DT, BTT, BTR)
• Risk factors for poor HRQOL outcomes at 12, 24 and 36 months after continuous flow LVAD implant
DVs: EQ-5D VAS and 5 dimensions, EQ-5D indexKCCQ (including domains and summary scores)
IVs: Demographic factors (e.g., age, gender, education)Clinical factors
pre (e.g., INTERMACS profiles, co-morbidities)post (e.g., adverse events)
Other risk factors (e.g., stress, coping, self-efficacy)• Analyses of specific domains of interest (e.g., social support, self-efficacy, symptom frequency / burden, etc.) • Utility analyses, QALYs, etc. INTERMACS Annual M
eeting
March 2012
Terminal Events and Risk Factors
D Naftel
Research Topics in INTERMACS
INTERMACS Annual Meeting
March 2012
0102030405060708090
100
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18
Continuous Flow Intracorporeal Device n=896, deaths=112
Pulsatile Flow Paracorporeal Device,
n=74, deaths=28
p (overall) < 0.0001
Event: Death (censored at transplant or recovery)
% S
urvi
val
Months after Device Implant
Pulsatile Flow Intracorporeal Device, n=470, deaths=140
INTERMACS: Survival After LVAD Implant
INTERMACS Annual Meeting
March 2012
0
20
40
60
80
100
0 3 6 9 12 15 18 21 240.000.020.040.060.080.100.120.140.160.180.20
Survival
% S
urvi
val
Months after Device Implant
Event: Death (censored at transplant or recovery)
Months % Survival 1 mo 94% 3 mo 89% 6 mo 84%12 mo 76%24 mo 63%
Survival after Primary LVAD(Pulsatile and Continuous Flow Devices)
Hazard
Deaths / M
onth (Hazard)
INTERMACS: Survival After LVAD Implant
INTERMACS Annual Meeting
March 2012
0102030405060708090
100
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18
65+ years, n=66, deaths=35
P (overall) <.0001
Event: Death (censored at transplant or recovery)
% S
urvi
val
Months after Device Implant
30 – 65 years, n=377, deaths=100
< 30 years, n=27, deaths=5
By Age Groups
INTERMACS: Survival after LVAD ImplantAdult Primary Pulsatile Intracorporeal Flow LVAD Pumps (n= 470)
INTERMACS Annual Meeting
March 2012
0102030405060708090
100
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18
65+ years, n=144, deaths=29
P (overall) = .002
Event: Death (censored at transplant or recovery)
% S
urvi
val
Months after Device Implant
30 – 65 years, n=691, deaths=81
< 30 years, n=61, deaths=2By Age Groups
INTERMACS: Survival after LVAD ImplantAdult Primary Continuous Intracorporeal Flow LVAD Pumps: n= 896
INTERMACS Annual Meeting
March 2012
Early Constant
Risk Factor Hazard ratio p-value Hazard ratio p-valueFemale 1.71 0.04 --- ---
Age (older) 1.141 0.006 1.131 0.008Previous CABG 2.71 <0.0001 --- ---Previous Valve Surgery 1.99 0.01 --- ---Dialysis (current) 2.45 0.01 --- ---INR (higher) 1.492 0.003 --- ---Ascites 2.32 0.002 --- ---RVEF: Severe --- --- 2.33 0.04RA Pressure (higher) 1.523 0.02 --- --- Cardiogenic Shock 1.98 0.003 --- --- BTC or DT --- --- 3.00 0.01
Pulsatile pump --- --- 3.02 0.001
1 Hazard ratio denotes the increased risk with a 20 year increase in age2 Hazard ratio denotes the increased risk with a 1.0 increase in INR
3 Hazard ratio denotes the increased risk of a 10-unit increase in RA pressure
INTERMACS: Survival After LVAD ImplantAdult Primary Intracorporeal LVADs (n=1366)
INTERMACS Annual Meeting
March 2012
0102030405060708090
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0 3 6 9 12 15 18 21 24
INTERMACS: Survival after LVAD ImplantAdult Primary Intracorporeal LVADs: n= 1366
Months after Device Implant
Pred
icte
d %
Sur
viva
l
Pulsatile Intracorporeal
Continuous Intracorporeal
Risk Factor Unadjusted Adjusted
Constant Phase Hazard ratio p-value Hazard ratio p-valuePulsatile pump 12.54 <0.0001 3.02 0.001
“Average” Patient
INTERMACS Annual Meeting
March 2012
33
Early Constant
Risk Factor Hazard ratio p-value Hazard ratio p-value
Age (older) 2.421 <.0001 1.551 .0005Bilirubin (higher) 1.412 .0002 --- --- RA Pressure (higher) 2.083 .0009 --- --- Cardiogenic Shock 1.97 .02 --- --- BTC or DT --- --- 1.80 .02Pulsatile pump --- --- 2.74 .001
Table 9Risk Factors for Death after Implant: June 2006 – March 2009 Primary LVAD: n=1092
1 Hazard ratio denotes the increased risk from age 60 to 70 years 2 Hazard ratio denotes the increased risk of a 2-unit increase in bilirubin3 Hazard ratio denotes the increased risk of a 10-unit increase in RA pressure
LVAD, left ventricular assist device; BTT, bridge to transplant; BTC, bridge to candidacy; DT, destination therapy; RA, right arterial
INTERMACS Annual Meeting
March 2012
Terminal Events and Risk Factors
What are the Next Steps?
• Improving Patient Outcomes• Device Evaluation and Development
Research Topics in INTERMACS
INTERMACS Annual Meeting
March 2012
Panel B: G. Functional CapacityH. Neurocognitive AssessmentI. Quality of LifeJ. Terminal Events and Risk FactorsK. Panel Discussion Young
Research Topics in INTERMACS
INTERMACS Annual Meeting
March 2012