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Published on: September 22, 2020
Validation of ERICVA Risk Score as a Predictor of One Year Amputation-Free Survival of Patients with Critical Limb
Sara-Azhari Mohamed1, Navian Lee Viknaswaran2, Jonathan Doran3
1Regenerative Medicine Institute, National University of Ireland Galway, Ireland; Department of Vascular Surgery, Galway University Hospital, Galway, Ireland.
Insights
The ERICVA risk score shows fair validity for predicting amputation-free survival in critical limb ischemia (CLI) patients. A simplified version offers similar predictive power and can replace the full score.
Area of Science:
- Vascular Surgery
- Clinical Risk Stratification
- Amputation Prevention
Background:
- Critical Limb Ischemia (CLI) poses a significant risk for amputation.
- The ERICVA score was developed to predict amputation-free survival (AFS) in CLI patients.
- External validation of the ERICVA score was lacking.
Purpose of the Study:
- To externally validate the ERICVA risk score system for predicting one-year amputation-free survival (AFS) in patients with critical limb ischemia (CLI).
- To compare the predictive performance of the full ERICVA scale (11 parameters) and a simplified version (5 parameters).
Main Methods:
- Prospective data collection from 179 CLI patients prescreened for a stem cell trial.
- Validation of full and simplified ERICVA scores using Area Under the Receiver Operating Characteristic (ROC) curve (AUC).
- Chi-square tests and Kaplan-Meier survival curves analyzed risk group association with one-year AFS.
Main Results:
- A significant association was found between ERICVA risk groups and one-year AFS (P=0.0007).
- Kaplan-Meier curves showed significant differences in AFS among risk groups (log-rank P < 0.001).
- AUC for the full and simplified scores were 0.63 and 0.61, respectively; simplified score had higher specificity (0.92 vs 0.84).
Conclusions:
- The ERICVA risk score demonstrates fair validity but is not a completely reliable predictor of one-year AFS in CLI patients.
- The simplified ERICVA score performs comparably to the full score and is recommended for clinical use.
- Further research may be needed to enhance the reliability of risk stratification for CLI patients.
Background:
The ERICVA score was derived to predict amputation-free survival in patients with critical limb ischemia (CLI). It may be a useful tool to stratify patients in trials of novel interventions to treat CLI but, as yet, it has not been externally validated.
Methods:
A prospective database of CLI patients was developed during prescreening of patients for a phase 1 stem cell therapy clinical trial. The primary outcome was amputation free survival (AFS) at 1 year. Both the full ERICVA scale (11 parameters) and simplified ERICVA scale (5 parameters) were validated. Data analysis was performed by calculation of the area under the receiver operating characteristic (ROC) curve examining the predictive value of the scores. The Chi-square test was used to examine the association between risk group and one-year AFS and the cumulative survival of the three risk groups was compared using Kaplan Meier survival curves.
Results:
A series of 179 CLI patients were included in the analysis. The Chi-square test of independence showed a significant association between the risk group (high, medium and low) and one-year AFS outcome (P = 0.0007). Kaplan-Meier survival curve showed significant difference in one-year AFS between the three risk groups (log-rank P < 0.001). The area under the curve (AUC) was found to be 0.63 and 0.61 for the full and simplified score, respectively. The sensitivity of the full score was 0.44 with specificity of 0.84. The simplified score had a sensitivity of 0.28 and specificity of 0.92.
Conclusion:
The ERICVA risk score system was found to have a fair validity but cannot be considered reliable as a single predictor of one year AFS of CLI patients. The simplified score had an AUC almost identical to the full score and can accordingly replace the full score.
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