1. More Than Survival: Futility
Suzanne V. Arnold, MD, MHA
Saint Luke’s Mid America Heart Institute/UMKC
March 12, 2016

2. Defining Futility When risks do not outweigh expected benefits
Risk of a poor outcome is too high
Treatment fails to achieve its designed benefits
Prolonged survival with reasonable quality of life
Improve heart failure symptoms without substantial other adverse side effects

3. Definition of Poor Outcome
Assessed at 1 year after LVAD
Death
Very poor heart failure-specific quality of life
KCCQ <45 over the year following LVAD
Missing from the definition:
Cognitive function
Stroke
Generic quality of life
Arnold et al., Circ Cardiovasc Qual Outcomes Sep 1;6(5):591-7.
Arnold et al., Circulation Jun 24;129(25):

4. Rate of Poor Outcome at 1 Year After DT-LVAD: 30%
VAD Patients v3.0 in INTERMACS
May 2012-Sept 2013
N=3922
–2208 BTT/possible BTT
–45 BTR, rescue, other
–31 BiVAD
–151 missing all comorbidity data
Analytic Cohort
N=1487
Died <1 year
N=336 (23%)
Survived
N=1151
–177 No KCCQ follow-up
Rate of Poor Outcome at 1 Year After DT-LVAD:
30%
Follow-up KCCQ data
N=974
Very Poor QoL
N=94 (7%)
Acceptable QoL
N=880 (70%)

5. Methods
Multivariable logistic model was built to predict a poor outcome at 1 year after DT-LVAD
18 baseline demographic and clinical variables
Parameter estimates penalized to minimize the effect of over-fitting
Inverse propensity weighting was used to adjust for loss to follow-up
Multiple imputation for missing data was performed via sequential regression modeling

6. Model OR (95% CI) P-value Age (per +10 years) 1.23 (1.08-1.40) 0.002
KCCQ-12 Summary Score (per -10 pts)
1.10 ( )
0.010
BMI (per +5 kg/m2)
1.12 ( )
0.017
INTERMACS Patient Profile 1-2
1.27 ( )
0.078
History of solid organ cancer
1.39 ( )
0.079
Previous cardiac operation
1.23 ( )
0.119
Hemoglobin (per +1 g/dL)
0.95 ( )
0.170
History of illicit drug use/alcohol abuse
1.29 ( )
0.189
Non-significant factors: sex, diabetes, stroke, PAD, creatinine, lung disease, albumin, arrhythmias, tricuspid regurgitation, KCCQ missing

7. Model Performance Discrimination: C-index=0.64, Validated=0.62
Calibration:
Slope=1.01, Intercept=0.01

8. Outcomes by Predicted Risk

9. When is an LVAD futile? Expected benefits > potential harm
Is there a predicted risk of poor outcome that is sufficiently high to claim futility?

10. Outcomes by Predicted Risk
10% of population
While nearly 1/3 of patients have poor outcomes over the year after DT-LVAD, identifying patients at such a high-risk of this poor outcome to deem the LVAD futile is unlikely

11. When is an LVAD futile? Expected benefits > potential harm
Is there a predicted risk of medical management sufficiently low to claim futility?

12. Outcomes by Predicted Risk of Poor Outcome with Medical Therapy
EVEREST Risk Score
N (%)
Predicted Risk with Meds (6m)
1-Year
Outcome with LVAD
Low
80 (6.1%)
12.9%
19.6%
Moderate
185 (14.1%)
25.2%
31.4%
High
67 (5.1%)
37.8%
24.3%
Not calculated
978 (74.7%) -
31.6%
Allen LA et al., Circ Cardiovasc Qual Outcomes Jul;4(4):

13. When is an LVAD futile? Patient perspective: Societal perspective:
Standards uncertain and may vary across patients
Societal perspective:
Much longer survival after LVAD
Consider using risk models and engage in shared decision-making

14. Thank you