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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.

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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

INTERMACS Annual Meeting

March 2012


Research Topics in INTERMACS

Functional Capacity

JoAnn Lindenfeld

So far we have learned little about functional capacity

INTERMACS Annual Meeting

March 2012


June 2006 – Sept 2008: Adult Prospective Implants

Pt Seen in 6 Minute WalkVO2 Max R at Peak

Follow-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


Frailty and Success of Rehabilitation, and Ultimate Quality of Life?

Increased Vulnerability to Stress

LVAD-Responsive Frailty

LVAD-Independent Frailty

Systolic and

diastolic dysfunction

Inflammation

Anorexia

Hypoxia

Polypharmacy

AGING

COPD / lung disease

Cancer

Diabetes

Osteoporosis

Peripheral vascular disease

Cirrhosis

Neurologic disease

↑PCWP and CVP

↓Cardiac output

Sarcopenia

Malnutrition

Cognitive deficits

Injurious falls

Impaired

Health Status

Disability

Loss of ADLs

Institutionalization

Post-Operative

Complications

Prolonged LOS

Need for ICU care

Reduced

Survival

INTERMACS Annual Meeting

March 2012

Flint et al

Circ: Heart Failure

In Press


LVAD-Independent Frailty and Success of Rehabilitation, and Ultimate Quality of Life?

LVAD-Responsive Frailty

Patient A

Patient B

Patient C

Pre-LVAD Frailty

Post-LVAD Frailty

INTERMACS Annual Meeting

March 2012

Favorable Outcome

Lower risk for premature death or complications, with marked improvement in functional status

Intermediate Outcome

Moderate risk for premature death and complications with some persistent functional limitation

Unfavorable Outcome

High risk for premature death and complications with failure to improve functional status

Flint et al

Circ: Heart Failure

In Press


Research Topics in INTERMACS and Success of Rehabilitation, and Ultimate Quality of Life?

  • 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?

INTERMACS Annual Meeting

March 2012


Research Topics in INTERMACS and Success of Rehabilitation, and Ultimate Quality of Life?

  • 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?

INTERMACS Annual Meeting

March 2012


Research Topics in INTERMACS and Success of Rehabilitation, and Ultimate Quality of Life?

Neurocognitive Assessment

K Grady

INTERMACS Annual Meeting

March 2012


Research Topics in INTERMACS and Success of Rehabilitation, and Ultimate Quality of Life?

  • 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.

INTERMACS Annual Meeting

March 2012


Research Topics in INTERMACS and Success of Rehabilitation, and Ultimate Quality of Life?

  • Neurocognitive Assessment

    • The biggest challenges with neurocognitive assessment in INTERMACS are:

      • Collecting the Data

      • Making neurocognitive assessment a part of MCSD standard of care

INTERMACS Annual Meeting

March 2012


Research Topics in INTERMACS and Success of Rehabilitation, and Ultimate Quality of Life?

  • Neurocognitive Assessment

    • What are the Next Steps?

      • Improving Patient Outcomes

      • Device Evaluation and Development

INTERMACS Annual Meeting

March 2012


Research Topics in INTERMACS and Success of Rehabilitation, and Ultimate Quality of Life?

Quality of Life

K Grady

INTERMACS Annual Meeting

March 2012


QOL Instrument and Success of Rehabilitation, and Ultimate Quality of Life?

EQ-5D

Health Questionnaire

English version for the US

Mobility

I have no problems in walking about q

I have some problems in walking about q

I am confined to bed q

Self-Care

I have no problems with self-care q

I have some problems washing or dressing myself q

I am unable to wash or dress myself q

Usual Activities (e.g. work, study, housework, family or

leisure activities)

I have no problems with performing my usual activities q

I have some problems with performing my usual activities q

I am unable to perform my usual activities q

Pain/Discomfort

I have no pain or discomfort q

I have moderate pain or discomfort q

I have extreme pain or discomfort q

Anxiety/Depression

I am not anxious or depressed q

I am moderately anxious or depressed q

I am extremely anxious or depressed q

INTERMACS Annual Meeting

March 2012


N=878 adult MCS patients, primary implant ( and Success of Rehabilitation, and Ultimate Quality of Life?pulsatile and continuous flow [LVAD, Bi-VAD, TAH]: 6/06-9/08); Profile 1 = 36%, Profile 2 = 38%

Pre and Post Implant EQ-5D

(primary implant, prospective, adult)

Visual Analogue Scale (VAS) Across Time (mean ± SD)

Best

(N=39)

(N=96)

(N=183)

EQ-5D VAS

(N=312)

P (pre vs 3 mo) <0.001

Worst

INTERMACS Annual Meeting

March 2012

Pre-Implant

3 month

6 month

12 month

Months Post Implant


Conclusions
CONCLUSIONS and Success of Rehabilitation, and Ultimate Quality of Life?

  • 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 and Success of Rehabilitation, and Ultimate Quality of Life?

  • 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 status

  • Schipper H, in Spilker B (ed) Quality of Life Assessment in Clinical Trials (1990)

INTERMACS Annual Meeting

March 2012


Implants: June 2006 – March 2010, Follow-up: March 2011 and Success of Rehabilitation, and Ultimate Quality of Life?

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

INTERMACS Annual Meeting

March 2012


June 2006 – March 2011: HRQOL by Patient Profiles and Success of Rehabilitation, and Ultimate Quality of Life?

(All patients with opportunity for 1 year follow-up (n=1559)

Alive (device in place) 100%

Alive (device in place) 83%

Alive (device in place) 69%

Alive (device in place) 50%

Proportion of Patients

Txpl 34%

Txpl 19%

Dead 9%

Dead 11%

Txpl 8%

Dead 15%

Rec 1%

Rec 1%

Rec 0%

Txpl 0%

INTERMACS Annual Meeting

March 2012

Dead 0%

Rec 0%

Pre-implant

Months Post Implant


EQ-5D: Visual Analog Scale and Success of Rehabilitation, and Ultimate Quality of Life?

Primary Continuous Flow LVADs, n=2807

Best

Health

Mean VAS

Worst

Health

INTERMACS Annual Meeting

March 2012

INTERMACS Patient Profile Levels


EQ-5D: Mobility, Any Problems and Success of Rehabilitation, and Ultimate Quality of Life?

Primary Continuous Flow LVADs, n=2807

% Patients with Any Mobility Problems

INTERMACS Annual Meeting

March 2012

INTERMACS Patient Profile Levels


EQ-5D: Self Care, Any Problems and Success of Rehabilitation, and Ultimate Quality of Life?

Primary Continuous Flow LVADs, n=2807

% Patients with Any Self Care Problems

INTERMACS Annual Meeting

March 2012

INTERMACS Patient Profile Levels


Predictors of better QOL at 6 months and Success of Rehabilitation, and Ultimate Quality of Life?after continuous flow MCS

  • 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


Research Topics in INTERMACS and Success of Rehabilitation, and Ultimate Quality of Life?

  • Quality of Life

    • What are the Next Steps?

      • Improving Patient Outcomes

      • Device Evaluation and Development

INTERMACS Annual Meeting

March 2012


What is next? and Success of Rehabilitation, and Ultimate Quality of Life?

  • 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 index

  • KCCQ (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 Meeting

March 2012


Research Topics in INTERMACS and Success of Rehabilitation, and Ultimate Quality of Life?

Terminal Events and Risk Factors

D Naftel

INTERMACS Annual Meeting

March 2012


INTERMACS: Survival After LVAD Implant and Success of Rehabilitation, and Ultimate Quality of Life?

Continuous Flow Intracorporeal Device n=896, deaths=112

Pulsatile Flow Intracorporeal Device, n=470, deaths=140

Pulsatile Flow Paracorporeal Device, n=74, deaths=28

% Survival

p (overall) < 0.0001

Event: Death (censored at transplant or recovery)

INTERMACS Annual Meeting

March 2012

Months after Device Implant


INTERMACS: Survival After LVAD Implant and Success of Rehabilitation, and Ultimate Quality of Life?

Survival after Primary LVAD

(Pulsatile and Continuous Flow Devices)

Survival

Months % Survival

1 mo 94%

3 mo 89%

6 mo 84%

12 mo 76%

24 mo 63%

% Survival

Deaths / Month (Hazard)

Hazard

Event: Death (censored at transplant or recovery)

INTERMACS Annual Meeting

March 2012

Months after Device Implant


INTERMACS: Survival after LVAD Implant and Success of Rehabilitation, and Ultimate Quality of Life?

Adult Primary Pulsatile Intracorporeal Flow LVAD Pumps (n= 470)

By Age Groups

< 30 years, n=27, deaths=5

30 – 65 years, n=377, deaths=100

% Survival

65+ years, n=66, deaths=35

P (overall) <.0001

Event: Death (censored at transplant or recovery)

INTERMACS Annual Meeting

March 2012

Months after Device Implant


INTERMACS: Survival after LVAD Implant and Success of Rehabilitation, and Ultimate Quality of Life?

Adult Primary Continuous Intracorporeal Flow LVAD Pumps: n= 896

By Age Groups

< 30 years, n=61, deaths=2

30 – 65 years, n=691, deaths=81

65+ years, n=144, deaths=29

% Survival

P (overall) = .002

Event: Death (censored at transplant or recovery)

INTERMACS Annual Meeting

March 2012

Months after Device Implant


INTERMACS: Survival After LVAD Implant and Success of Rehabilitation, and Ultimate Quality of Life?

Adult Primary Intracorporeal LVADs (n=1366)

Early Constant

Risk Factor Hazard ratio p-value Hazard ratio p-value

Female 1.71 0.04 --- ---

Age (older) 1.141 0.006 1.131 0.008

Previous 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 0.04

RA 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 age

2 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 Annual Meeting

March 2012


INTERMACS: Survival after LVAD Implant and Success of Rehabilitation, and Ultimate Quality of Life?

Adult Primary Intracorporeal LVADs: n= 1366

Continuous Intracorporeal

Pulsatile Intracorporeal

“Average” Patient

Predicted % Survival

Risk Factor Unadjusted Adjusted

Constant Phase Hazard ratio p-value Hazard ratio p-value

Pulsatile pump 12.54 <0.0001 3.02 0.001

INTERMACS Annual Meeting

March 2012

Months after Device Implant


Risk Factors for Death after Implant and Success of Rehabilitation, and Ultimate Quality of Life?

Table 9

: June 2006 – March 2009

Primary LVAD: n=1092

Early Constant

Risk Factor Hazard ratio p-value Hazard ratio p-value

Age (older) 2.421 <.0001 1.551 .0005

Bilirubin (higher) 1.412 .0002 --- ---

RA Pressure (higher) 2.083 .0009 --- ---

Cardiogenic Shock 1.97 .02 --- ---

BTC or DT --- --- 1.80 .02

Pulsatile pump --- --- 2.74 .001

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 bilirubin

3 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


Research Topics in INTERMACS and Success of Rehabilitation, and Ultimate Quality of Life?

  • Terminal Events and Risk Factors

    • What are the Next Steps?

      • Improving Patient Outcomes

      • Device Evaluation and Development

INTERMACS Annual Meeting

March 2012


Research Topics in INTERMACS and Success of Rehabilitation, and Ultimate Quality of Life?

  • Panel B:

    • Functional Capacity

    • Neurocognitive Assessment

    • Quality of Life

    • Terminal Events and Risk Factors

    • Panel Discussion Young

INTERMACS Annual Meeting

March 2012


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