AIM OF THE STUDY: To retrospectively create a predictive score for estimating amputation-free survival (AFS) in patients with critical limb ischemia (CLI) operated on with the use of a heparin-bonded expanded polytetrafluoroethylene (ePTFE) bypass graft (Hb-ePTFE). METHODS: Over a 13-year period, ending in March 2015, a Hb-ePTFE graft was implanted in 683 patients undergoing below-knee revascularization for CLI in seven Italian vascular hospitals. Data concerning these interventions were retrospectively collected in a multicenter registry with a dedicated database. Univariate and multivariable analyses with Kaplan-Meier estimates were used to identify potential significant predictors of AFS at 5 years, and then a predictive risk score was constructed. A qualitative assessment of the Kaplan-Meier survival estimates for each integer score was performed, and subgroups of risk were stratified on the basis of the primary end point. RESULTS: Overall, estimated 5-year AFS rate was 48.3 % (SE 0.024). At multivariate analysis, older age, coronary artery disease, end-stage renal disease, tissue loss and poor runoff score were predictors of AFS. The integer score ranged from 0 to 11; Kaplan-Meier analysis for AFS in each score group identified three subgroups with significant differences at 5 years: low-risk subgroup (scores from 0 to 2, 67.7 %), medium-risk subgroup (scores 3 and 4, 49.2 %, p < 0.001 in comparison with low-risk subgroup) and high-risk subgroup (scores from 5 to 11, 25.2 %, p < 0.001 in comparison with either low-risk subgroup or medium-risk subgroup). CONCLUSIONS: A category of low-risk patients with CLI treated with the indexed graft does exist, thus suggesting a primary role for Hb-ePTFE in such patients. A prospective validation of such a score is necessary.

A Multicenter Predictive Score for Amputation-Free Survival for Patients Operated on with an Heparin-Bonded ePTFE Graft for Critical Limb Ischemia

Piffaretti G.;Castelli P.;
2017-01-01

Abstract

AIM OF THE STUDY: To retrospectively create a predictive score for estimating amputation-free survival (AFS) in patients with critical limb ischemia (CLI) operated on with the use of a heparin-bonded expanded polytetrafluoroethylene (ePTFE) bypass graft (Hb-ePTFE). METHODS: Over a 13-year period, ending in March 2015, a Hb-ePTFE graft was implanted in 683 patients undergoing below-knee revascularization for CLI in seven Italian vascular hospitals. Data concerning these interventions were retrospectively collected in a multicenter registry with a dedicated database. Univariate and multivariable analyses with Kaplan-Meier estimates were used to identify potential significant predictors of AFS at 5 years, and then a predictive risk score was constructed. A qualitative assessment of the Kaplan-Meier survival estimates for each integer score was performed, and subgroups of risk were stratified on the basis of the primary end point. RESULTS: Overall, estimated 5-year AFS rate was 48.3 % (SE 0.024). At multivariate analysis, older age, coronary artery disease, end-stage renal disease, tissue loss and poor runoff score were predictors of AFS. The integer score ranged from 0 to 11; Kaplan-Meier analysis for AFS in each score group identified three subgroups with significant differences at 5 years: low-risk subgroup (scores from 0 to 2, 67.7 %), medium-risk subgroup (scores 3 and 4, 49.2 %, p < 0.001 in comparison with low-risk subgroup) and high-risk subgroup (scores from 5 to 11, 25.2 %, p < 0.001 in comparison with either low-risk subgroup or medium-risk subgroup). CONCLUSIONS: A category of low-risk patients with CLI treated with the indexed graft does exist, thus suggesting a primary role for Hb-ePTFE in such patients. A prospective validation of such a score is necessary.
2017
Dorigo, W.; Piffaretti, G.; Pulli, R.; Castelli, P.; Pratesi, C.; Alessi Innocenti, A.; Pratesi, G.; De Blasis, G.; Scalisi, L.; Monaca, V.; Battaglia, G.; Dorrucci, V.; Vecchiati, E.; Casali, G.; Ferilli, F.; Ottavi, P.; Franchin, M.
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11383/2059704
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