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Decision Making: Easy 89 yo Non-ambulatory Multiple failed - - PDF document
Decision Making: Easy 89 yo Non-ambulatory Multiple failed - - PDF document
4/8/19 Survival Predictions in CLTI: How to Use it in Clinical Decision Making Andres Schanzer, MD University of Massachusetts Medical School UCSF Vascular Symposium Decision Making: Easy 89 yo Non-ambulatory Multiple failed
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Predicting Outcomes
Risk Stratification Decision Making
CLTI is associated with a high risk
- f cardiovascular events including
major limb loss, myocardial infarction, stroke and death.
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Open surgical bypass traditionally has been the gold standard method for revascularization. Alternative Treatment Strategies
- 1. Endovascular techniques
- 2. Primary amputation
- 3. Conservative management
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Goal: To develop and validate a prognostic risk index for patients with CLTI considered for bypass surgery
Research Design and Methods
§ Study Design
§ Retrospective review of three prospectively collected databases to derive and then validate a risk prediction model
§ Data Sources
§ PREVENT III┼
§ 1404 CLTI patients from 83 hospitals
§ External validation cohort*
§ 716 CLTI patients from 3 hospitals (BWH, USF, Sarasota Memorial)
§ VSGNE§
§ 1166 CLTI patients from 11 hospitals
┼Schanzer et al, JVS, 2009. *Schanzer et al, JVS, 2010. §Schanzer et al, JVS, 2011.
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PIII CLTI Risk Score Development
- 1. PREVENT III cohort randomly divided
into a derivation set and a validation set
1404 patients 953 patients 451 patients
Two-Thirds: PIII Derivation Set One-Third: PIII Validation Set
- 1. Derivation
§ Multivariable model converted to a standard integer score system
- 2. Validation
§ Internal validation (PIII validation set, n=451) § External validation (External multicenter cohort, n=716) § External validation (VSGNE, n=1166) § External validation (Finland, n=1425)
PIII CLTI Risk Score Development
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Results
Multivariable Model for 1-Year AFS
Dialysis CLI criterion Age ≥ 75 years Hematocrit < 30 History of advanced CAD COVARIATES 2.81 (1.97, 3.99) <0.0001 2.22 (1.43, 3.44) 0.0004 1.64 (1.21-2.22) 0.001 1.61 (1.11, 2.34) 0.012 1.41 (1.05, 1.88) 0.021 HR (95% CI) P-Value
- re
1.03 0.80 0.50 0.48 0.34 β coefficient 4 2.8 3 2.2 2 1 2 1.6 1 1.4 ient Integer score
1 93.1 2 89.7 3 86.2 4 81.1 5 76.1 6 74.5 7 71.7 8 63 9 51 10 44 11 27.3 12 33 Risk Score Amputation-Free Survival (%)
PIII Derivation Set Stratified by Risk Score
Dialysis CLI criterion Age ≥ 75 years Hematocrit < 30 History of advanced CAD COVARIATES β coeff 4 2 3 2 2 1 2 1 1 1 nt Integer score
LOW MED HIGH
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Discrimination
PIII Derivation Set Stratified by Risk Score
Risk Categories Integer Score Amputation- Free Survival HR p-value Low ≤3 85.9 1.0 (ref) __ Medium 4-7 73.0 2.11 (1.54-2.89) <.0001 High ≥8 44.6 5.50 (3.73-8.10) <.0001
10 20 30 40 50 60 70 80 90
AMP-FREE SURVIVAL RATES (%)
LOW RISK ≤3 Points MEDIUM RISK 4-7 Points HIGH RISK ≥8 Points
86% 73% 45%
PREVENT III DERIVATION SET N=953
10 20 30 40 50 60 70 80 90
AMP-FREE SURVIVAL RATES (%)
LOW RISK ≤3 Points MEDIUM RISK 4-7 Points HIGH RISK ≥8 Points
86% 73% 45%
PREVENT III DERIVATION SET N=953
PIII RISK SCORE for CRITICAL LIMB ISCHEMIA
POINTS DIALYSIS 4 TISSUE LOSS 3 AGE ≥ 75 2 HCT ≤ 30% 2 CAD 1
10 20 30 40 50 60 70 80 90 AMP-FREE SURVIVAL RATES (%)
LOW RISK ≤3 Points MEDIUM RISK 4-7 Points HIGH RISK ≥8 Points
86% 73% 45%
PIII RISK SCORE for CRITICAL LIMB ISCHEMIA
POINTS DIALYSIS 4 TISSUE LOSS 3 AGE ≥ 75 2 HCT ≤ 30% 2 CAD 1
10 20 30 40 50 60 70 80 90 AMP-FREE SURVIVAL RATES (%)
LOW RISK ≤3 Points MEDIUM RISK 4-7 Points HIGH RISK ≥8 Points
86% 73% 45%
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Internal Validation
10 20 30 40 50 60 70 80 90
AMP-FREE SURVIVAL RATES (%)
LOW RISK <4 Points MEDIUM RISK 4-8 Points HIGH RISK >8 Points
88% 64% 45%
PREVENT III VALIDATION SET N=451
10 20 30 40 50 60 70 80 90
AMP-FREE SURVIVAL RATES (%)
LOW RISK <4 Points MEDIUM RISK 4-8 Points HIGH RISK >8 Points
88% 64% 45%
PREVENT III VALIDATION SET N=451
10 20 30 40 50 60 70 80 90
AMP-FREE SURVIVAL RATES (%)
LOW RISK ≤3 Points MEDIUM RISK 4-7 Points HIGH RISK ≥8 Points
86% 73% 45%
PREVENT III DERIVATION SET N=953
10 20 30 40 50 60 70 80 90
AMP-FREE SURVIVAL RATES (%)
LOW RISK ≤3 Points MEDIUM RISK 4-7 Points HIGH RISK ≥8 Points
86% 73% 45%
PREVENT III DERIVATION SET N=953
External Validation 1
10 20 30 40 50 60 70 80 90
AMP-FREE SURVIVAL RATES (%)
LOW RISK ≤3 Points MEDIUM RISK 4-7 Points HIGH RISK ≥8 Points
86% 73% 45%
PREVENT III DERIVATION SET N=953
10 20 30 40 50 60 70 80 90
AMP-FREE SURVIVAL RATES (%)
LOW RISK ≤3 Points MEDIUM RISK 4-7 Points HIGH RISK ≥8 Points
86% 73% 45%
PREVENT III DERIVATION SET N=953
10 20 30 40 50 60 70 80 90
AMP-FREE SURVIVAL RATES (%)
LOW RISK ≤3 Points MEDIUM RISK 4-7 Points HIGH RISK ≥8 Points
86% 70% 48%
BWH/USF/FSU DATASET N=716
10 20 30 40 50 60 70 80 90
AMP-FREE SURVIVAL RATES (%)
LOW RISK ≤3 Points MEDIUM RISK 4-7 Points HIGH RISK ≥8 Points
86% 70% 48%
BWH/USF/FSU DATASET N=716
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External Validation 2
10 20 30 40 50 60 70 80 90
AMP-FREE SURVIVAL RATES (%)
LOW RISK ≤3 Points MEDIUM RISK 4-7 Points HIGH RISK ≥8 Points
86% 73% 45%
PREVENT III DERIVATION SET N=953
10 20 30 40 50 60 70 80 90
AMP-FREE SURVIVAL RATES (%)
LOW RISK ≤3 Points MEDIUM RISK 4-7 Points HIGH RISK ≥8 Points
86% 73% 45%
PREVENT III DERIVATION SET N=953
10 20 30 40 50 60 70 80 90
AMP-FREE SURVIVAL RATES (%)
LOW RISK <4 Points MEDIUM RISK 4-8 Points HIGH RISK >8 Points
86% 74% 56%
VSGNNE DATASET N=1166
10 20 30 40 50 60 70 80 90
AMP-FREE SURVIVAL RATES (%)
LOW RISK <4 Points MEDIUM RISK 4-8 Points HIGH RISK >8 Points
86% 74% 56%
VSGNNE DATASET N=1166
Results-Validation
AFS at One Year by Risk Category
47.8 86.4 74.1 56.1 44.6 73 85.9 45.0 63.7 87.7 70.1 86.3
10 20 30 40 50 60 70 80 90 100 Low (≤3) Medium (4-7) High (≥8) Risk category (integer score) Amputation-Free Survival PIII Derivation Set (n=953) PIII Validation Set (n=451) Retrospective Validation Set (n=716) VSGNNE VALIDATION SET (n=1166)
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Results-Validation
JVS, November, 2010
Discussion
§ The PIII Risk Score is easily used at initial presentation using five simple dichotomous variables:
Dialysis-Dependency Tissue Loss on Presentation Hematocrit ≤ 30% History of Advanced CAD Age ≥ 75
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Conclusions
§ The PIII Risk Score is GENERALIZABLE
Dialysis-Dependency Tissue Loss on Presentation Hematocrit ≤ 30% History of Advanced CAD Age ≥ 75
The PIII risk score is a useful clinical tool for treatment decision planning
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VSGNE LEB Risk Prediction Models
§ Amputation or graft occlusion at 1 year* § Death at 1 year§ § Ambulation status at 1 year┼ § Clinical failure, despite graft patency, at 1 year°
┼Goodney et al, JVS, 2009.
*Goodney et al, Annals of Vasc Surg, 2010.
§Goodney et al, JVS, 2010.
°Simons et al, JVS, 2010.
*Goodney et al, Annals of Vasc Surg, 2010.
“Patients with no risk factors had…amputation rates <1%; patients with >3 risk factors had nearly 30% chance of suffering amputation.”
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§Goodney et al, JVS, 2010.
“Patients with no risk factors had 1-year death rates…<5%; patients with >3 risk factors had 28% chance
- f dying by 1 year.”
§Goodney et al, JVS, 2009.
“Likelihood of nonambulatory status at 1 year was <5% in patients with no risk factors and nearly 50% in patients with >3.”
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°Simons et al, JVS, 2010.
“After lower extremity bypass for CLTI, 10% of patients with a patent graft did not achieve clinical improvement at 1 year.”
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§ We lack validated instruments to accurately answer this question § We can predict some specific outcomes at specific time points with relatively reliable accuracy (i.e. <50% likelihood that patient is alive with an intact limb) § The best we can do is try to use available data to help inform patient and physician decision-making
Risk Assessment in the CLTI Patient: Who is Likely to Benefit from Revascularization and Who is Not?
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Problem: 1 year or 2 year outcomes at most
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“greatest magnitude of effect associated with age >80 years, oxygen- dependent chronic
- bstructive pulmonary
disease, stage 5 chronic kidney disease, and bedbound status.” “Procedure type (open/endo) was not significant in any models…”
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